Traumatic Brain Injury
Conditions
Keywords
severe, hypoxic-ischemic encephalopathy, stroke, intracranial hemorrhage, cerebral palsy, chronic, neurological injury
Brief summary
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.
Detailed description
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.
Interventions
BIOLOGICALHB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells
Sponsors
The University of Texas Health Science Center, Houston
Hope Biosciences LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, non-randomized study to determine safety and treatment effect of three infusions of HB-adMSC (2 x 10\^8 total cells per dose) in adult patients with sub-acute or chronic neurological injury
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. adults between 18 and 55 years of age 2. documented head injury with functional neurological damage to the central nervous system unlikely to improve with present standard of care approaches 3. a Glasgow Outcome Scale-Extended (GOS-E) score \> 2 and ≤ 6 4. onset or diagnosis of the injury or disease process greater than 6 months 5. ability to obtain consent from the subject of their legally authorized representative (LAR) 6. ability to speak English or Spanish \*required for validated neurocognitive outcome testing) -
Exclusion criteria
1. known history of: 1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, 2. recently treated infection, 3. renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL), 4. hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL), 5. cancer, 6. immunosuppression (screening WBC \< 3, 000 cells/ml), 7. HIV+, 8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study, 9. acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation, 10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia, 11. known sensitivity to heparin, Lovenox, and pork products, 12. individuals with mechanical prosthetic heart valves. 13. individuals who have received a stem cell treatment. 2. Normal brain CT/MRI exam 3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam 4. diagnosed with a genetic or metabolic disorder related to the neurologic condition 5. other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation 6. for women of child bearing potential, a positive pregnancy test at the screening visit, or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study 7. participation in a concurrent interventional study 8. inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments 9. unwilling or unable to return for follow-up study visits -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs (Respiratory Rate) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate |
| Vital Signs (Temperature) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature |
| Vital Signs (Systolic Blood Pressure) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure |
| Vital Signs (Diastolic Blood Pressure) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure |
| Vital Signs (Pulse Rate) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate |
| Vital Signs (Oxygen Saturation) | Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation |
| Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure |
| Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure |
| Vital Signs Change From Baseline (Pulse Rate) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate |
| Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation |
| Vital Signs Change From Baseline (Respiratory Rate) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate |
| Vital Signs Change From Baseline (Temperature) | Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4) | Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free Active TGF-Beta1 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Free active TGF-Beta1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 799 pg/mL to 7374 pg/mL |
| Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Count of Participants with specific GOS-E scores at Visits 3, 6, and 7 Glasgow Outcome Scale-Extended is an 8-point scale that classifies the global outcome for individuals with traumatic brain injury (TBI), ranging from 1 (dead) to 8 (upper good recovery). The categorical rating is based on a structured interview about the patient's ability to function. Higher scores indicate better recovery. Category 3 is Lower Severe Disability, Category 4 is Upper Severe Disability, Category 5 is Lower Moderate Disability, and Category 6 is Upper Moderate Disability. |
| Disability Rating Scale (DRS) Functional Outcomes | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and SD of Disability Rating Scale (DRS) evaluation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Disability Rating Scale score provides a numerical measure of an individual's functional impairment and disability. This assessment uses a 0-30 total score to assess traumatic brain injury, with higher scores indicating greater disability. A score of 0 indicates a rating of no disability and a score of 30 indicates a rating of profound vegetative state. |
| Galveston Orientation and Amnesia Test Neuropsychological Outcomes | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Mean and SD of Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The total score is calculated by subtracting an error score from 100. The error score is calculated by summing together the individual error score points from each question. The minimum total score of -3 is associated with a failure to respond correctly to any memory/orientation question. A total score of 100 indicates perfect recall on the GOAT memory/orientation questions. Higher total scores indicate better recall. |
| Brief Symptoms Inventory 18 (BSI 18) SOM T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Brief Symptoms Inventory 18 (BSI 18) Somatization (SOM) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized. |
| Brief Symptoms Inventory 18 (BSI 18) DEP T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Brief Symptoms Inventory 18 (BSI 18) Depression (DEP) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized. |
| Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized. |
| Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. The Global Severity Index (GSI) is the sum of the three subscores, which was then normalized with a t-score in this analysis. A T-score was calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction with SRA T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average. |
| NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Cognition: Picture Vocabulary Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Cognition: Picture Vocabulary Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. |
| Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Delay Test consists of calculating the total number of words recalled on the delayed recall trial (after a 20-30 minute delay). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized. |
| Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 Test consists of calculating the total number of words correctly recalled across the five initial learning trials (Trials 1-5). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized. |
| Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome. |
| Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome. |
| Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Wechsler Adult Intelligence Scale - IV: Processing Speed Composite Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome. |
| Controlled Oral Word Association Test (COWAT) Total Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | Controlled Oral Word Association Test (COWAT) Total Scaled Scores Mean and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The COWAT is scored by counting the number of correct words a person produces in one minute for each of the three given letters. The total score is the sum of the unique words generated across all three trials. Higher scores are considered a better outcome. The raw total score is then compared to normative data that is based on factors such as age and education level. The scaled score has a mean of 10 and a standard deviation of 3. A t-score of \< 20 indicates severe impairment. |
| MRI Structural Measures - Global White Matter | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Global White Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Global Gray Matter | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Global Gray Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Global Corpus Callosum Matter | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Global Corpus Callosum Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Hippocampus (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Hippocampus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Amygdala (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Amygdala (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Thalamus (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Thalamus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Caudate (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Caudate (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| Interleukin 4 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-4 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 1940 pg/mL to 6060 pg/mL |
| MRI Structural Measures - Pallidum (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Pallidum (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Insula (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Insula (Bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Hippocampus (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Hippocampus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Hippocampus (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Hippocampus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Amygdala (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Amygdala (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Amygdala (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Amygdala (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Thalamus (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Thalamus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Thalamus (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Thalamus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Caudate (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Caudate (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Caudate (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Caudate (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Putamen (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Putamen (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Putamen (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Putamen (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Pallidum (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Pallidum (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Pallidum (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Pallidum (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Insula (Left) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Insula (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Insula (Right) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Insula (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| MRI Structural Measures - Putamen (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28) | MRI Structural Measures - Putamen (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3. |
| Interleukin 2 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-2 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 363 pg/mL to 1909 pg/mL |
| Interleukin 1-beta | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-1-beta lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1615 pg/mL to 6930 pg/mL |
| Interferon Gamma-induced Protein 10 (IP-10) | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IP-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 5270 pg/mL to 15466 pg/mL |
| Tumor Necrosis Factor Alpha | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | TNFα lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 232 pg/mL to 4570 pg/mL |
| Monocyte Chemoattractant Protein-1 (MCP-1) | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | MCP-1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1439 pg/mL to 7472 pg/mL |
| Interleukin Protein-17A (IL-17a) | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-17a lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values measure 526 pg/mL to 3228 pg/mL |
| Interleukin 6 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-6 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 750 pg/mL to 4740 pg/mL |
| Interleukin 10 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 497 pg/mL to 2796 pg/mL |
| IFN-gamma | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IFN-gamma lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 764 pg/mL to 6591 pg/mL |
| IL-12p70 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-12p70 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 676 pg/mL to 3975 pg/mL |
| IL-8 | Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) | IL-8 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1348 pg/mL to 7738 pg/mL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify.
Placebo: Placebo will be administered intravenously to study participants who qualify. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 10 |
| Age, Customized | 33 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 175 cm STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight | 73 kg STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Vital Signs Change From Baseline (Diastolic Blood Pressure)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0) | 71.0 mmHg | Standard Deviation 10.42 |
| HB-adMSC | Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 2 (Visit 4 - Week 2) | 69.4 mmHg | Standard Deviation 10.24 |
| HB-adMSC | Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | -1.7 mmHg | Standard Deviation 8.69 |
| HB-adMSC | Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 3 (Visit 5 - Week 4) | 68.8 mmHg | Standard Deviation 9.31 |
| HB-adMSC | Vital Signs Change From Baseline (Diastolic Blood Pressure) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | -2.1 mmHg | Standard Deviation 8.81 |
Primary
Vital Signs Change From Baseline (Oxygen Saturation)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 1/Baseline (Visit 3 - Week 0) | 97.1 % of oxygen | Standard Deviation 4.63 |
| HB-adMSC | Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 2 (Visit 4 - Week 2) | 97.5 % of oxygen | Standard Deviation 1.97 |
| HB-adMSC | Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | 0.4 % of oxygen | Standard Deviation 4.59 |
| HB-adMSC | Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 3 (Visit 5 - Week 4) | 96.7 % of oxygen | Standard Deviation 5.15 |
| HB-adMSC | Vital Signs Change From Baseline (Oxygen Saturation) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | -0.5 % of oxygen | Standard Deviation 6.82 |
Primary
Vital Signs Change From Baseline (Pulse Rate)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Pulse Rate) | Infusion 1/Baseline (Visit 3 - Week 0) | 72.0 beats/min | Standard Deviation 11.26 |
| HB-adMSC | Vital Signs Change From Baseline (Pulse Rate) | Infusion 2 (Visit 4 - Week 2) | 70.5 beats/min | Standard Deviation 11.15 |
| HB-adMSC | Vital Signs Change From Baseline (Pulse Rate) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | -1.4 beats/min | Standard Deviation 10.79 |
| HB-adMSC | Vital Signs Change From Baseline (Pulse Rate) | Infusion 3 (Visit 5 - Week 4) | 72.1 beats/min | Standard Deviation 11.02 |
| HB-adMSC | Vital Signs Change From Baseline (Pulse Rate) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | 0.1 beats/min | Standard Deviation 11.15 |
Primary
Vital Signs Change From Baseline (Respiratory Rate)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Respiratory Rate) | Infusion 1/Baseline (Visit 3 - Week 0) | 16.4 breaths/min | Standard Deviation 1.67 |
| HB-adMSC | Vital Signs Change From Baseline (Respiratory Rate) | Infusion 2 (Visit 4 - Week 2) | 16.4 breaths/min | Standard Deviation 1.14 |
| HB-adMSC | Vital Signs Change From Baseline (Respiratory Rate) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | 0.0 breaths/min | Standard Deviation 1.4 |
| HB-adMSC | Vital Signs Change From Baseline (Respiratory Rate) | Infusion 3 (Visit 5 - Week 4) | 16.4 breaths/min | Standard Deviation 1.03 |
| HB-adMSC | Vital Signs Change From Baseline (Respiratory Rate) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | 0.0 breaths/min | Standard Deviation 1.83 |
Primary
Vital Signs Change From Baseline (Systolic Blood Pressure)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0) | 115.3 mmHg | Standard Deviation 14.73 |
| HB-adMSC | Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 2 (Visit 4 - Week 2) | 113.8 mmHg | Standard Deviation 16.06 |
| HB-adMSC | Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | -1.7 mmHg | Standard Deviation 11.1 |
| HB-adMSC | Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 3 (Visit 5 - Week 4) | 114.3 mmHg | Standard Deviation 15.18 |
| HB-adMSC | Vital Signs Change From Baseline (Systolic Blood Pressure) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | -1.0 mmHg | Standard Deviation 11.18 |
Primary
Vital Signs Change From Baseline (Temperature)
Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs Change From Baseline (Temperature) | Infusion 1/Baseline (Visit 3 - Week 0) | 36.7 degrees Celsius | Standard Deviation 0.29 |
| HB-adMSC | Vital Signs Change From Baseline (Temperature) | Infusion 2 (Visit 4 - Week 2) | 36.7 degrees Celsius | Standard Deviation 0.25 |
| HB-adMSC | Vital Signs Change From Baseline (Temperature) | Infusion 2 (Visit 4 - Week 2) Change from Baseline | 0.0 degrees Celsius | Standard Deviation 0.35 |
| HB-adMSC | Vital Signs Change From Baseline (Temperature) | Infusion 3 (Visit 5 - Week 4) | 36.7 degrees Celsius | Standard Deviation 0.29 |
| HB-adMSC | Vital Signs Change From Baseline (Temperature) | Infusion 3 (Visit 5 - Week 4) Change from Baseline | -0.0 degrees Celsius | Standard Deviation 0.36 |
Primary
Vital Signs (Diastolic Blood Pressure)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Diastolic Blood Pressure) | 1 year Post-Infusion (Visit 7 - Week 56) | 74 mmHg | Standard Deviation 8 |
| HB-adMSC | Vital Signs (Diastolic Blood Pressure) | Screening/Pre-Infusion (Visit 1) | 73 mmHg | Standard Deviation 9 |
| HB-adMSC | Vital Signs (Diastolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0) | 72 mmHg | Standard Deviation 8 |
| HB-adMSC | Vital Signs (Diastolic Blood Pressure) | 6 months Post-Infusion (Visit 6 - Week 28) | 74 mmHg | Standard Deviation 10 |
Primary
Vital Signs (Oxygen Saturation)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Oxygen Saturation) | Screening/Pre-Infusion (Visit 1) | 98.87 % of oxygen | Standard Deviation 1.6 |
| HB-adMSC | Vital Signs (Oxygen Saturation) | Infusion 1/Baseline (Visit 3 - Week 0) | 98.68 % of oxygen | Standard Deviation 1.84 |
| HB-adMSC | Vital Signs (Oxygen Saturation) | 6 months Post-Infusion (Visit 6 - Week 28) | 98.37 % of oxygen | Standard Deviation 1.74 |
| HB-adMSC | Vital Signs (Oxygen Saturation) | 1 year Post-Infusion (Visit 7 - Week 56) | 98.79 % of oxygen | Standard Deviation 1.25 |
Primary
Vital Signs (Pulse Rate)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Pulse Rate) | Screening/Pre-Infusion (Visit 1) | 80 beats/min | Standard Deviation 12 |
| HB-adMSC | Vital Signs (Pulse Rate) | Infusion 1/Baseline (Visit 3 - Week 0) | 78 beats/min | Standard Deviation 9 |
| HB-adMSC | Vital Signs (Pulse Rate) | 6 months Post-Infusion (Visit 6 - Week 28) | 80 beats/min | Standard Deviation 16 |
| HB-adMSC | Vital Signs (Pulse Rate) | 1 year Post-Infusion (Visit 7 - Week 56) | 76 beats/min | Standard Deviation 13 |
Primary
Vital Signs (Respiratory Rate)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Respiratory Rate) | Screening/Pre-Infusion (Visit 1) | 16.54 breaths/min | Standard Deviation 1.22 |
| HB-adMSC | Vital Signs (Respiratory Rate) | Infusion 1/Baseline (Visit 3 - Week 0) | 16.82 breaths/min | Standard Deviation 1.59 |
| HB-adMSC | Vital Signs (Respiratory Rate) | 6 months Post-Infusion (Visit 6 - Week 28) | 16.63 breaths/min | Standard Deviation 0.96 |
| HB-adMSC | Vital Signs (Respiratory Rate) | 1 year Post-Infusion (Visit 7 - Week 56) | 16.42 breaths/min | Standard Deviation 0.84 |
Primary
Vital Signs (Systolic Blood Pressure)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Systolic Blood Pressure) | Screening/Pre-Infusion (Visit 1) | 119 mmHg | Standard Deviation 16 |
| HB-adMSC | Vital Signs (Systolic Blood Pressure) | Infusion 1/Baseline (Visit 3 - Week 0) | 119 mmHg | Standard Deviation 14 |
| HB-adMSC | Vital Signs (Systolic Blood Pressure) | 6 months Post-Infusion (Visit 6 - Week 28) | 117 mmHg | Standard Deviation 14 |
| HB-adMSC | Vital Signs (Systolic Blood Pressure) | 1 year Post-Infusion (Visit 7 - Week 56) | 119 mmHg | Standard Deviation 14 |
Primary
Vital Signs (Temperature)
Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature
Time frame: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Vital Signs (Temperature) | Screening/Pre-Infusion (Visit 1) | 36.76 degrees Celsius | Standard Deviation 0.55 |
| HB-adMSC | Vital Signs (Temperature) | Infusion 1/Baseline (Visit 3 - Week 0) | 42.49 degrees Celsius | Standard Deviation 18.18 |
| HB-adMSC | Vital Signs (Temperature) | 6 months Post-Infusion (Visit 6 - Week 28) | 39.85 degrees Celsius | Standard Deviation 13.68 |
| HB-adMSC | Vital Signs (Temperature) | 1 year Post-Infusion (Visit 7 - Week 56) | 39.96 degrees Celsius | Standard Deviation 14.08 |
Secondary
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 54.74 t-score | Standard Deviation 10.85 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 48.37 t-score | Standard Deviation 9.06 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 47.85 t-score | Standard Deviation 8.71 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0295% CI: [-8.12, -0.79]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.002995% CI: [-9.297, -2.103]Mixed Models Analysis
Secondary
Brief Symptoms Inventory 18 (BSI 18) DEP T Scores
Brief Symptoms Inventory 18 (BSI 18) Depression (DEP) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) DEP T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 57.17 t-score | Standard Deviation 12.83 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) DEP T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 52.58 t-score | Standard Deviation 11.65 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) DEP T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 51.00 t-score | Standard Deviation 11.68 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.06995% CI: [-7.55, 0.26]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.02695% CI: [-9.983, -2.317]Mixed Models Analysis
Secondary
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. The Global Severity Index (GSI) is the sum of the three subscores, which was then normalized with a t-score in this analysis. A T-score was calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 57.48 t-score | Standard Deviation 11.14 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 52.00 t-score | Standard Deviation 10.37 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 50.60 t-score | Standard Deviation 10.69 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.05495% CI: [-7.33, 0.02]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.002395% CI: [-9.456, -2.244]Mixed Models Analysis
Secondary
Brief Symptoms Inventory 18 (BSI 18) SOM T Scores
Brief Symptoms Inventory 18 (BSI 18) Somatization (SOM) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) SOM T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 56.52 t-score | Standard Deviation 9.85 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) SOM T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 52.42 t-score | Standard Deviation 8.93 |
| HB-adMSC | Brief Symptoms Inventory 18 (BSI 18) SOM T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 51.60 t-score | Standard Deviation 7.86 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.1995% CI: [-6.07, -1.18]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.04395% CI: [-7.26, -0.14]Mixed Models Analysis
Secondary
Controlled Oral Word Association Test (COWAT) Total Scaled Scores
Controlled Oral Word Association Test (COWAT) Total Scaled Scores Mean and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The COWAT is scored by counting the number of correct words a person produces in one minute for each of the three given letters. The total score is the sum of the unique words generated across all three trials. Higher scores are considered a better outcome. The raw total score is then compared to normative data that is based on factors such as age and education level. The scaled score has a mean of 10 and a standard deviation of 3. A t-score of \< 20 indicates severe impairment.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Controlled Oral Word Association Test (COWAT) Total Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 8.88 score on a scale | Standard Deviation 3.26 |
| HB-adMSC | Controlled Oral Word Association Test (COWAT) Total Scaled Scores | Month 66 months Post-Infusion (Visit 6 - Week 28) | 8.69 score on a scale | Standard Deviation 2.3 |
| HB-adMSC | Controlled Oral Word Association Test (COWAT) Total Scaled Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 10.00 score on a scale | Standard Deviation 2.65 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.8495% CI: [-1.23, 0.97]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.05395% CI: [-0.028, 2.162]Regression, Linear
Secondary
Disability Rating Scale (DRS) Functional Outcomes
Mean and SD of Disability Rating Scale (DRS) evaluation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Disability Rating Scale score provides a numerical measure of an individual's functional impairment and disability. This assessment uses a 0-30 total score to assess traumatic brain injury, with higher scores indicating greater disability. A score of 0 indicates a rating of no disability and a score of 30 indicates a rating of profound vegetative state.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Disability Rating Scale (DRS) Functional Outcomes | Infusion 1/Baseline (Visit 3 - Week 0) | 4.54 score on a scale | Standard Deviation 3.89 |
| HB-adMSC | Disability Rating Scale (DRS) Functional Outcomes | 6 months Post-Infusion (Visit 6 - Week 28) | 4.65 score on a scale | Standard Deviation 4.07 |
| HB-adMSC | Disability Rating Scale (DRS) Functional Outcomes | 1 year Post-Infusion (Visit 7 - Week 56) | 3.30 score on a scale | Standard Deviation 2 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.04795% CI: [-0.75, -0.01]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0002395% CI: [-1.12, -0.379]Mixed Models Analysis
Secondary
Free Active TGF-Beta1
Free active TGF-Beta1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 799 pg/mL to 7374 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Free Active TGF-Beta1 | Infusion 1/Baseline (Visit 3 - Week 0) | 1684 pg/mL | Standard Deviation 1580 |
| HB-adMSC | Free Active TGF-Beta1 | 6 months Post-Infusion (Visit 6 - Week 28) | 2252 pg/mL | Standard Deviation 2251 |
| HB-adMSC | Free Active TGF-Beta1 | 1 year Post-Infusion (Visit 7 - Week 56) | 1755 pg/mL | Standard Deviation 1244 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.6Mixed Models Analysis
Secondary
Galveston Orientation and Amnesia Test Neuropsychological Outcomes
Mean and SD of Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The total score is calculated by subtracting an error score from 100. The error score is calculated by summing together the individual error score points from each question. The minimum total score of -3 is associated with a failure to respond correctly to any memory/orientation question. A total score of 100 indicates perfect recall on the GOAT memory/orientation questions. Higher total scores indicate better recall.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Galveston Orientation and Amnesia Test Neuropsychological Outcomes | Infusion 1/Baseline (Visit 3 - Week 0) | 91.74 score on a scale | Standard Deviation 7.81 |
| HB-adMSC | Galveston Orientation and Amnesia Test Neuropsychological Outcomes | 6 months Post-Infusion (Visit 6 - Week 28) | 95.89 score on a scale | Standard Deviation 4.93 |
| HB-adMSC | Galveston Orientation and Amnesia Test Neuropsychological Outcomes | 1 year Post-Infusion (Visit 7 - Week 56) | 96.10 score on a scale | Standard Deviation 4.56 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0002795% CI: [2.42, 7.29]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0001995% CI: [2.506, 7.294]Mixed Models Analysis
Secondary
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes
Count of Participants with specific GOS-E scores at Visits 3, 6, and 7 Glasgow Outcome Scale-Extended is an 8-point scale that classifies the global outcome for individuals with traumatic brain injury (TBI), ranging from 1 (dead) to 8 (upper good recovery). The categorical rating is based on a structured interview about the patient's ability to function. Higher scores indicate better recovery. Category 3 is Lower Severe Disability, Category 4 is Upper Severe Disability, Category 5 is Lower Moderate Disability, and Category 6 is Upper Moderate Disability.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 3 at 6 months Post-Infusion (Visit 6 - Week 28) | 6 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 4 at 6 months Post-Infusion (Visit 6 - Week 28) | 3 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 5 at 6 months Post-Infusion (Visit 6 - Week 28) | 2 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 6 at 6 months Post-Infusion (Visit 6 - Week 28) | 9 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 3 at 1 year Post-Infusion (Visit 7 - Week 56) | 5 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 4 at 1 year Post-Infusion (Visit 7 - Week 56) | 2 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 5 at 1 year Post-Infusion (Visit 7 - Week 56) | 3 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 6 at 1 year Post-Infusion (Visit 7 - Week 56) | 10 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 3 at Infusion 1/Baseline (Visit 3 - Week 0) | 7 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 4 at Infusion 1/Baseline (Visit 3 - Week 0) | 5 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 5 at Infusion 1/Baseline (Visit 3 - Week 0) | 2 Participants |
| HB-adMSC | Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes | Category 6 at Infusion 1/Baseline (Visit 3 - Week 0) | 10 Participants |
Comparison: A proportional odds logistic regression model was used to analyze the data over time. This model is used to predict an ordered categorical outcome over time by assuming the odds ratio between any two outcome categories is constant throughout all time points. Null hypothesis is that time has no effect on the cumulative odds for a patient to be in a higher category after being evaluated on the GOS-E. Odds ratio \>1 indicates higher likelihood of being in higher categories compared to at baseline.p-value: 0.6395% CI: [0.43, 4.19]Regression, Logistic
Comparison: A proportional odds logistic regression model was used to analyze the data over time. This model is used to predict an ordered categorical outcome over time by assuming the odds ratio between any two outcome categories is constant throughout all time points. Null hypothesis is that time has no effect on the cumulative odds for a patient to be in a higher category after being evaluated on the GOS-E. Odds ratio \>1 indicates higher likelihood of being in higher categories compared to at baseline.p-value: 0.3695% CI: [0.55, 5.45]Regression, Logistic
Secondary
IFN-gamma
IFN-gamma lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 764 pg/mL to 6591 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | IFN-gamma | Infusion 1/Baseline (Visit 3 - Week 0) | 1419 pg/mL | Standard Deviation 826 |
| HB-adMSC | IFN-gamma | 6 months Post-Infusion (Visit 6 - Week 28) | 2940 pg/mL | Standard Deviation 1779 |
| HB-adMSC | IFN-gamma | 1 year Post-Infusion (Visit 7 - Week 56) | 1696 pg/mL | Standard Deviation 679 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.002Mixed Models Analysis
Secondary
IL-12p70
IL-12p70 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 676 pg/mL to 3975 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | IL-12p70 | Infusion 1/Baseline (Visit 3 - Week 0) | 1835 pg/mL | Standard Deviation 385 |
| HB-adMSC | IL-12p70 | 6 months Post-Infusion (Visit 6 - Week 28) | 1708 pg/mL | Standard Deviation 1097 |
| HB-adMSC | IL-12p70 | 1 year Post-Infusion (Visit 7 - Week 56) | 1893 pg/mL | Standard Deviation 652 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.8Mixed Models Analysis
Secondary
IL-8
IL-8 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1348 pg/mL to 7738 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | IL-8 | Infusion 1/Baseline (Visit 3 - Week 0) | 2477 pg/mL | Standard Deviation 927 |
| HB-adMSC | IL-8 | 6 months Post-Infusion (Visit 6 - Week 28) | 3667 pg/mL | Standard Deviation 2161 |
| HB-adMSC | IL-8 | 1 year Post-Infusion (Visit 7 - Week 56) | 3023 pg/mL | Standard Deviation 1181 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.069Mixed Models Analysis
Secondary
Interferon Gamma-induced Protein 10 (IP-10)
IP-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 5270 pg/mL to 15466 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interferon Gamma-induced Protein 10 (IP-10) | Infusion 1/Baseline (Visit 3 - Week 0) | 8090 pg/mL | Standard Deviation 2762 |
| HB-adMSC | Interferon Gamma-induced Protein 10 (IP-10) | 6 months Post-Infusion (Visit 6 - Week 28) | 8158 pg/mL | Standard Deviation 2210 |
| HB-adMSC | Interferon Gamma-induced Protein 10 (IP-10) | 1 year Post-Infusion (Visit 7 - Week 56) | 7426 pg/mL | Standard Deviation 1828 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.1Mixed Models Analysis
Secondary
Interleukin 10
IL-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 497 pg/mL to 2796 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin 10 | Infusion 1/Baseline (Visit 3 - Week 0) | 1020 pg/mL | Standard Deviation 388 |
| HB-adMSC | Interleukin 10 | 6 months Post-Infusion (Visit 6 - Week 28) | 1129 pg/mL | Standard Deviation 777 |
| HB-adMSC | Interleukin 10 | 1 year Post-Infusion (Visit 7 - Week 56) | 1087 pg/mL | Standard Deviation 337 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.8Mixed Models Analysis
Secondary
Interleukin 1-beta
IL-1-beta lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1615 pg/mL to 6930 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin 1-beta | Infusion 1/Baseline (Visit 3 - Week 0) | 3267 pg/mL | Standard Deviation 780 |
| HB-adMSC | Interleukin 1-beta | 6 months Post-Infusion (Visit 6 - Week 28) | 3709 pg/mL | Standard Deviation 1763 |
| HB-adMSC | Interleukin 1-beta | 1 year Post-Infusion (Visit 7 - Week 56) | 3478 pg/mL | Standard Deviation 1226 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.6Mixed Models Analysis
Secondary
Interleukin 2
IL-2 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 363 pg/mL to 1909 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin 2 | Infusion 1/Baseline (Visit 3 - Week 0) | 652 pg/mL | Standard Deviation 221 |
| HB-adMSC | Interleukin 2 | 6 months Post-Infusion (Visit 6 - Week 28) | 828 pg/mL | Standard Deviation 517 |
| HB-adMSC | Interleukin 2 | 1 year Post-Infusion (Visit 7 - Week 56) | 973 pg/mL | Standard Deviation 324 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.2Mixed Models Analysis
Secondary
Interleukin 4
IL-4 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 1940 pg/mL to 6060 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin 4 | Infusion 1/Baseline (Visit 3 - Week 0) | 2694 pg/mL | Standard Deviation 939 |
| HB-adMSC | Interleukin 4 | 6 months Post-Infusion (Visit 6 - Week 28) | 4236 pg/mL | Standard Deviation 2561 |
| HB-adMSC | Interleukin 4 | 1 year Post-Infusion (Visit 7 - Week 56) | 3388 pg/mL | Standard Deviation 1296 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.048Mixed Models Analysis
Secondary
Interleukin 6
IL-6 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 750 pg/mL to 4740 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin 6 | Infusion 1/Baseline (Visit 3 - Week 0) | 1501 pg/mL | Standard Deviation 574 |
| HB-adMSC | Interleukin 6 | 6 months Post-Infusion (Visit 6 - Week 28) | 1609 pg/mL | Standard Deviation 1379 |
| HB-adMSC | Interleukin 6 | 1 year Post-Infusion (Visit 7 - Week 56) | 1695 pg/mL | Standard Deviation 681 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: >0.9Mixed Models Analysis
Secondary
Interleukin Protein-17A (IL-17a)
IL-17a lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values measure 526 pg/mL to 3228 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Interleukin Protein-17A (IL-17a) | Infusion 1/Baseline (Visit 3 - Week 0) | 1529 pg/mL | Standard Deviation 532 |
| HB-adMSC | Interleukin Protein-17A (IL-17a) | 6 months Post-Infusion (Visit 6 - Week 28) | 1410 pg/mL | Standard Deviation 827 |
| HB-adMSC | Interleukin Protein-17A (IL-17a) | 1 year Post-Infusion (Visit 7 - Week 56) | 1736 pg/mL | Standard Deviation 639 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.5Mixed Models Analysis
Secondary
Monocyte Chemoattractant Protein-1 (MCP-1)
MCP-1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1439 pg/mL to 7472 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Monocyte Chemoattractant Protein-1 (MCP-1) | Infusion 1/Baseline (Visit 3 - Week 0) | 4600 pg/mL | Standard Deviation 1602 |
| HB-adMSC | Monocyte Chemoattractant Protein-1 (MCP-1) | 6 months Post-Infusion (Visit 6 - Week 28) | 4745 pg/mL | Standard Deviation 1122 |
| HB-adMSC | Monocyte Chemoattractant Protein-1 (MCP-1) | 1 year Post-Infusion (Visit 7 - Week 56) | 5090 pg/mL | Standard Deviation 833 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.6Mixed Models Analysis
Secondary
MRI Structural Measures - Amygdala (Bilateral)
MRI Structural Measures - Amygdala (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Amygdala (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 1,926 SupraMD volume (mm3) | Standard Deviation 457 |
| HB-adMSC | MRI Structural Measures - Amygdala (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 1,794 SupraMD volume (mm3) | Standard Deviation 496 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.0395% CI: [-41.11, -2.65]Mixed Models Analysis
Secondary
MRI Structural Measures - Amygdala (Left)
MRI Structural Measures - Amygdala (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Amygdala (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 870 SupraMD volume (mm3) | Standard Deviation 195 |
| HB-adMSC | MRI Structural Measures - Amygdala (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 813 SupraMD volume (mm3) | Standard Deviation 243 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.06795% CI: [-19.79, 0.59]Mixed Models Analysis
Secondary
MRI Structural Measures - Amygdala (Right)
MRI Structural Measures - Amygdala (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Amygdala (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 1,055 SupraMD volume (mm3) | Standard Deviation 326 |
| HB-adMSC | MRI Structural Measures - Amygdala (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 982 SupraMD volume (mm3) | Standard Deviation 290 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.06995% CI: [-25.45, 0.88]Mixed Models Analysis
Secondary
MRI Structural Measures - Caudate (Bilateral)
MRI Structural Measures - Caudate (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Caudate (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 3,760 SupraMD volume (mm3) | Standard Deviation 771 |
| HB-adMSC | MRI Structural Measures - Caudate (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 3,523 SupraMD volume (mm3) | Standard Deviation 636 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.1895% CI: [-98.67, 19.56]Mixed Models Analysis
Secondary
MRI Structural Measures - Caudate (Left)
MRI Structural Measures - Caudate (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Caudate (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 1,786 SupraMD volume (mm3) | Standard Deviation 253 |
| HB-adMSC | MRI Structural Measures - Caudate (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 1,679 SupraMD volume (mm3) | Standard Deviation 220 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.07995% CI: [-37.83, 2.01]Mixed Models Analysis
Secondary
MRI Structural Measures - Caudate (Right)
MRI Structural Measures - Caudate (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Caudate (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 1,974 SupraMD volume (mm3) | Standard Deviation 578 |
| HB-adMSC | MRI Structural Measures - Caudate (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 1,844 SupraMD volume (mm3) | Standard Deviation 483 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2995% CI: [-62.91, 19.61]Mixed Models Analysis
Secondary
MRI Structural Measures - Global Corpus Callosum Matter
MRI Structural Measures - Global Corpus Callosum Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Global Corpus Callosum Matter | Infusion 1/Baseline (Visit 3 - Week 0) | 836 SupraMD volume (mm3) | Standard Deviation 274 |
| HB-adMSC | MRI Structural Measures - Global Corpus Callosum Matter | 6 months Post-Infusion (Visit 6 - Week 28) | 757 SupraMD volume (mm3) | Standard Deviation 258 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.1995% CI: [-33.32, 6.98]Mixed Models Analysis
Secondary
MRI Structural Measures - Global Gray Matter
MRI Structural Measures - Global Gray Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Global Gray Matter | Infusion 1/Baseline (Visit 3 - Week 0) | 430,058 SupraMD volume (mm3) |
| HB-adMSC | MRI Structural Measures - Global Gray Matter | 6 months Post-Infusion (Visit 6 - Week 28) | 427,864 SupraMD volume (mm3) |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.6195% CI: [-1835.1, 1103.97]Mixed Models Analysis
Secondary
MRI Structural Measures - Global White Matter
MRI Structural Measures - Global White Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Global White Matter | Infusion 1/Baseline (Visit 3 - Week 0) | 114,303 SupraMD volume (mm3) |
| HB-adMSC | MRI Structural Measures - Global White Matter | 6 months Post-Infusion (Visit 6 - Week 28) | 108,002 SupraMD volume (mm3) |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2795% CI: [-2958.69, 858.19]Mixed Models Analysis
Secondary
MRI Structural Measures - Hippocampus (Bilateral)
MRI Structural Measures - Hippocampus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Hippocampus (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 6,475 SupraMD volume (mm3) |
| HB-adMSC | MRI Structural Measures - Hippocampus (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 6,281 SupraMD volume (mm3) |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.007295% CI: [-54.61, -10.09]Mixed Models Analysis
Secondary
MRI Structural Measures - Hippocampus (Left)
MRI Structural Measures - Hippocampus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Hippocampus (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 3,180 SupraMD volume (mm3) | Standard Deviation 453 |
| HB-adMSC | MRI Structural Measures - Hippocampus (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 3,140 SupraMD volume (mm3) | Standard Deviation 503 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.3195% CI: [-19.5, 6.34]Mixed Models Analysis
Secondary
MRI Structural Measures - Hippocampus (Right)
MRI Structural Measures - Hippocampus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Hippocampus (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 3,295 SupraMD volume (mm3) | Standard Deviation 663 |
| HB-adMSC | MRI Structural Measures - Hippocampus (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 3,141 SupraMD volume (mm3) | Standard Deviation 646 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.01895% CI: [-46.25, -5.29]Mixed Models Analysis
Secondary
MRI Structural Measures - Insula (Bilateral)
MRI Structural Measures - Insula (Bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Insula (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 4,985 SupraMD volume (mm3) | — |
| HB-adMSC | MRI Structural Measures - Insula (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 4,772 SupraMD volume (mm3) | Standard Deviation 967 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2495% CI: [-95.21, 24.36]Mixed Models Analysis
Secondary
MRI Structural Measures - Insula (Left)
MRI Structural Measures - Insula (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Insula (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 2,071 SupraMD volume (mm3) | Standard Deviation 575 |
| HB-adMSC | MRI Structural Measures - Insula (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 2,016 SupraMD volume (mm3) | Standard Deviation 422 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.6695% CI: [-51.62, 33.16]Mixed Models Analysis
Secondary
MRI Structural Measures - Insula (Right)
MRI Structural Measures - Insula (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Insula (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 2,914 SupraMD volume (mm3) | Standard Deviation 748 |
| HB-adMSC | MRI Structural Measures - Insula (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 2,756 SupraMD volume (mm3) | Standard Deviation 688 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2495% CI: [-70.22, 17.84]Mixed Models Analysis
Secondary
MRI Structural Measures - Pallidum (Bilateral)
MRI Structural Measures - Pallidum (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Pallidum (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 450 SupraMD volume (mm3) | Standard Deviation 393 |
| HB-adMSC | MRI Structural Measures - Pallidum (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 459 SupraMD volume (mm3) | Standard Deviation 448 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.8595% CI: [-14.84, 17.79]Mixed Models Analysis
Secondary
MRI Structural Measures - Pallidum (Left)
MRI Structural Measures - Pallidum (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Pallidum (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 179 SupraMD volume (mm3) | Standard Deviation 150 |
| HB-adMSC | MRI Structural Measures - Pallidum (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 159 SupraMD volume (mm3) | Standard Deviation 125 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2395% CI: [-8.67, 2.17]Mixed Models Analysis
Secondary
MRI Structural Measures - Pallidum (Right)
MRI Structural Measures - Pallidum (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Pallidum (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 272 SupraMD volume (mm3) | Standard Deviation 319 |
| HB-adMSC | MRI Structural Measures - Pallidum (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 300 SupraMD volume (mm3) | Standard Deviation 407 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.595% CI: [-9.43, 18.88]Mixed Models Analysis
Secondary
MRI Structural Measures - Putamen (Bilateral)
MRI Structural Measures - Putamen (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Putamen (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 901 SupraMD volume (mm3) | Standard Deviation 1169 |
| HB-adMSC | MRI Structural Measures - Putamen (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 951 SupraMD volume (mm3) | Standard Deviation 1396 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.6395% CI: [-26.01, 42.51]Mixed Models Analysis
Secondary
MRI Structural Measures - Putamen (Left)
MRI Structural Measures - Putamen (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Putamen (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 224 SupraMD volume (mm3) | Standard Deviation 135 |
| HB-adMSC | MRI Structural Measures - Putamen (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 199 SupraMD volume (mm3) | Standard Deviation 106 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2495% CI: [-11.01, 2.84]Mixed Models Analysis
Secondary
MRI Structural Measures - Putamen (Right)
MRI Structural Measures - Putamen (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Putamen (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 678 SupraMD volume (mm3) |
| HB-adMSC | MRI Structural Measures - Putamen (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 752 SupraMD volume (mm3) |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.4495% CI: [-19.69, 44.36]Mixed Models Analysis
Secondary
MRI Structural Measures - Thalamus (Bilateral)
MRI Structural Measures - Thalamus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Thalamus (Bilateral) | Infusion 1/Baseline (Visit 3 - Week 0) | 4,952 SupraMD volume (mm3) | Standard Deviation 798 |
| HB-adMSC | MRI Structural Measures - Thalamus (Bilateral) | 6 months Post-Infusion (Visit 6 - Week 28) | 4,700 SupraMD volume (mm3) | Standard Deviation 778 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.06195% CI: [-85.66, 1.61]Mixed Models Analysis
Secondary
MRI Structural Measures - Thalamus (Left)
MRI Structural Measures - Thalamus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Thalamus (Left) | Infusion 1/Baseline (Visit 3 - Week 0) | 2,522 SupraMD volume (mm3) | Standard Deviation 439 |
| HB-adMSC | MRI Structural Measures - Thalamus (Left) | 6 months Post-Infusion (Visit 6 - Week 28) | 2,363 SupraMD volume (mm3) | Standard Deviation 437 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.02795% CI: [-49.12, -3.61]Mixed Models Analysis
Secondary
MRI Structural Measures - Thalamus (Right)
MRI Structural Measures - Thalamus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | MRI Structural Measures - Thalamus (Right) | Infusion 1/Baseline (Visit 3 - Week 0) | 2,431 SupraMD volume (mm3) | Standard Deviation 388 |
| HB-adMSC | MRI Structural Measures - Thalamus (Right) | 6 months Post-Infusion (Visit 6 - Week 28) | 2,337 SupraMD volume (mm3) | Standard Deviation 422 |
Comparison: Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.p-value: 0.2495% CI: [-42.09, 10.77]Mixed Models Analysis
Secondary
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 36.65 t-score | Standard Deviation 8.95 |
| HB-adMSC | NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 38.05 t-score | Standard Deviation 8.57 |
| HB-adMSC | NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 40.47 t-score | Standard Deviation 11.89 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.2195% CI: [-1.52, 6.65]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0495% CI: [0.241, 8.399]Regression, Linear
Secondary
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 31.68 t-score | Standard Deviation 10.83 |
| HB-adMSC | NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 28.58 t-score | Standard Deviation 9.81 |
| HB-adMSC | NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 31.58 t-score | Standard Deviation 10.04 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.395% CI: [-2.52, 0.78]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.3395% CI: [-0.83, 2.409]Regression, Linear
Secondary
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 40.43 t-score | Standard Deviation 9.61 |
| HB-adMSC | NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 39.37 t-score | Standard Deviation 9.33 |
| HB-adMSC | NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 43.00 t-score | Standard Deviation 10.96 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.9695% CI: [-3.49, 3.66]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.195% CI: [-0.588, 6.562]Regression, Linear
Secondary
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 30.65 t-score | Standard Deviation 14.11 |
| HB-adMSC | NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 35.42 t-score | Standard Deviation 17.12 |
| HB-adMSC | NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 39.68 t-score | Standard Deviation 18.35 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.008195% CI: [1.58, 9.77]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0001795% CI: [4.42, 12.606]Regression, Linear
Secondary
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Cognition: Picture Vocabulary Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 43.74 t-score | Standard Deviation 9.56 |
| HB-adMSC | NIH Toolbox - Cognition: Picture Vocabulary Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 41.96 t-score | Standard Deviation 8.48 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.6495% CI: [-2.767, 4.515]Regression, Linear
Secondary
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 26.21 t-score | Standard Deviation 18.82 |
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 20.20 t-score | Standard Deviation 15.06 |
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 25.09 t-score | Standard Deviation 20.43 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.2495% CI: [-1.73, 6.44]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.06195% CI: [-0.152, 7.72]Regression, Linear
Secondary
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 26.81 t-score | Standard Deviation 13.21 |
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 27.61 t-score | Standard Deviation 13.28 |
| HB-adMSC | NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 27.94 t-score | Standard Deviation 15.28 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.04395% CI: [0.13, 6.53]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.195% CI: [-0.484, 5.917]Regression, Linear
Secondary
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Delay Test consists of calculating the total number of words recalled on the delayed recall trial (after a 20-30 minute delay). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 31.95 t-score | Standard Deviation 16.24 |
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 30.57 t-score | Standard Deviation 19.02 |
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 37.49 t-score | Standard Deviation 19.2 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.4995% CI: [-2.28, 4.71]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0002695% CI: [3.506, 10.494]Regression, Linear
Secondary
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 Test consists of calculating the total number of words correctly recalled across the five initial learning trials (Trials 1-5). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 31.01 t-score | Standard Deviation 16.34 |
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 36.74 t-score | Standard Deviation 16.94 |
| HB-adMSC | Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 28.42 t-score | Standard Deviation 14.76 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.08395% CI: [-0.51, 8.46]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0002595% CI: [4.55, 13.52]Regression, Linear
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 37.29 t-score | Standard Deviation 8.85 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 41.85 t-score | Standard Deviation 7.01 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 42.72 t-score | Standard Deviation 9.01 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.009795% CI: [0.79, 5.22]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0001795% CI: [2.335, 6.685]Mixed Models Analysis
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 47.76 t-score | Standard Deviation 8.91 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 52.18 t-score | Standard Deviation 7.08 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 52.39 t-score | Standard Deviation 10.6 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.04995% CI: [0.04, 5.14]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.006995% CI: [1.054, 6.056]Mixed Models Analysis
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 40.10 t-score | Standard Deviation 8.82 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 43.51 t-score | Standard Deviation 8.82 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 44.95 t-score | Standard Deviation 7.7 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.006495% CI: [1.21, 6.82]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.0007695% CI: [2.251, 7.759]Mixed Models Analysis
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 39.36 t-score | Standard Deviation 11.85 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 40.12 t-score | Standard Deviation 11.73 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 40.73 t-score | Standard Deviation 11.3 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.008495% CI: [0.86, 5.38]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.01895% CI: [0.5, 4.94]Mixed Models Analysis
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction with SRA T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 41.96 t-score | Standard Deviation 6.5 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 44.53 t-score | Standard Deviation 4.26 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 44.35 t-score | Standard Deviation 5.04 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.02495% CI: [0.33, 4.13]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.01795% CI: [0.445, 4.175]Mixed Models Analysis
Secondary
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 37.20 t-score | Standard Deviation 10.98 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 36.65 t-score | Standard Deviation 9.76 |
| HB-adMSC | TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 38.74 t-score | Standard Deviation 9.39 |
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.1195% CI: [-0.35, 3.31]Mixed Models Analysis
Comparison: Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.004695% CI: [0.893, 4.487]Mixed Models Analysis
Secondary
Tumor Necrosis Factor Alpha
TNFα lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 232 pg/mL to 4570 pg/mL
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Tumor Necrosis Factor Alpha | Infusion 1/Baseline (Visit 3 - Week 0) | 1246 pg/mL | Standard Deviation 775 |
| HB-adMSC | Tumor Necrosis Factor Alpha | 6 months Post-Infusion (Visit 6 - Week 28) | 1694 pg/mL | Standard Deviation 1497 |
| HB-adMSC | Tumor Necrosis Factor Alpha | 1 year Post-Infusion (Visit 7 - Week 56) | 1553 pg/mL | Standard Deviation 609 |
Comparison: For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.p-value: 0.4Mixed Models Analysis
Secondary
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 6.58 score on a scale | Standard Deviation 3.29 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 5.88 score on a scale | Standard Deviation 3.18 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 6.71 score on a scale | Standard Deviation 3.69 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.5395% CI: [-0.55, 1.05]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.195% CI: [0.284, 1.805]Regression, Linear
Secondary
Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores
Wechsler Adult Intelligence Scale - IV: Processing Speed Composite Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 82.05 score on a scale | Standard Deviation 17.62 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 79.44 score on a scale | Standard Deviation 15.12 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 83.24 score on a scale | Standard Deviation 19.23 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.1395% CI: [-0.84, 6.41]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.01695% CI: [0.938, 8.026]Regression, Linear
Secondary
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of Average being 90-109, High Average 110-119, Low Average 80-89, Borderline 70-79, and Extremely Low below 70. Higher scores mean better outcome.
Time frame: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Population: Some subjects either withdrew or were lost to follow-up before specific time points of the study, causing slight variation of subject population between visits. Additionally, some subjects missed various assessments at different points of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores | Infusion 1/Baseline (Visit 3 - Week 0) | 6.24 score on a scale | Standard Deviation 3.73 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores | 6 months Post-Infusion (Visit 6 - Week 28) | 6.06 score on a scale | Standard Deviation 2.88 |
| HB-adMSC | Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores | 1 year Post-Infusion (Visit 7 - Week 56) | 6.83 score on a scale | Standard Deviation 3.81 |
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.03495% CI: [0.07, 1.59]Regression, Linear
Comparison: Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.p-value: 0.00995% CI: [0.284, 1.805]Regression, Linear