Post COVID-19 Syndrome
Conditions
Brief summary
This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.
Detailed description
Active Product: HB- adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells - allogeneic) Dose: 200 million Route: Intravenous Regimen: Weeks 0, 2, 6, and 10. Placebo: Saline Solution 0.9% Dose: N/A Route: Intravenous Regimen: Weeks 0, 2, 6, and 10.Duration of administration 1 hour Laboratory Samples. Screening, Week 0, 6, and 26. Visits by Weeks Screening Week 0 - Infusion 1 Week 2 - Infusion 2 Week 6 - Infusion 3 Week 10 - Infusion 4 Week 14 - Follow Up 1 Week 20 - Follow Up 2 Week 26 - End of Study
Interventions
BIOLOGICALHB-adMSCs (allogeneic)
HB-adMSCs allogenic
OTHERPlacebo
Placebo comarator
Sponsors
Hope Biosciences Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Amber bags will be used to 'blind' the participant and investigator to which group the subject belongs in.
Intervention model description
Randomized Double-Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
A study participant will be eligible for inclusion in this study only if all the following criteria apply: 1 Male and female participants 18 - 70 years of age. 2\. Participants in the study have proof of Post COVID-19 Syndrome in their medical records. 3\. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial. 4\. The study participant is experiencing one or more neurological symptoms for at least 12 weeks, either continually or intermittently, with relapses not experienced pre-illness that interferes with regular daily activities. Symptoms must be new symptoms or dramatic worsening of preexisting symptoms, i.e., the subject didn't have symptoms and had not sought medical treatment for the symptoms before COVID-19, or the symptoms are dramatically worse (in severity and frequency). At least one symptom must have a severity of 5cm on the neurological symptom VAS at screening. See the list of symptoms below: * Extreme fatigue: Feeling overtired with low energy and a strong desire to sleep. * Brain Fog: A diminished mental capacity marked by the inability to concentrate, think or reason clearly interferes with daily activities. * Headache: Sharp or dull reoccurring or intermittent that were not present pre-illness. * Sleep Issues: Any sleep disturbances in sleep quality that makes sleep seem inadequate or unrefreshing like insomnia or hypersomnia. * Loss of Taste/Smell: A diminished sense of taste or smell. 5\. Study participants should be able to read, understand, and provide written consent. 6\. Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration. 7\. If their sexual partners can become pregnant, male participants should use a method of contraception during study participation and for six months after the last administration of the experimental drug. \* 8\. The study participant is able and willing to comply with the requirements of this clinical trial.
Exclusion criteria
A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply: 1. The subject is unable to provide informed consent or to comply with study requirements. 2. A study participant has currently been diagnosed with active COVID-19 disease, defined as ongoing symptoms related to acute infection (such as fever or chills, cough, shortness of breath, or difficulty breathing, among other symptoms), and evidence of a positive RT-PCR SARS- CoV-2. 3. The subject is unwilling to agree to the use of acceptable methods of contraception \* throughout the study and for six months after the last dose of the investigational product. 4. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take adequate contraceptive measures. \* 5. The study participant has a history of addiction or dependency, or he or she is currently abusing or using substances. 6. Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma. 7. The study participant has one or more significant concurrent medical conditions (verified by medical records), including the following: * Diabetes Mellitus (DM) Poorly controlled diabetes mellitus (PCDM), defined as a history of deficient standard of care treatment or pre-prandial glucose \>130mg/dl during screening visit or post-prandial glucose \>200mg/dl. * Chronic kidney disease (CKD): Medical History of Chronic kidney disease (CKD) diagnosis or screening results of eGFR \< 59mL/min/1.73m2. Subjects with any form of kidney dialysis will be excluded from participation in this clinical trial. * Heart Failure Presence of New York Heart Association (NYHA) Class III/IV heart failure during the screening visit. * Myocardial Infarction: Medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina. * High Blood Pressure: Medical history of uncontrolled high blood pressure is defined as a deficient standard of care treatment or blood pressure \> 140/90 mm/Hg during the screening visit in a patient taking anti-hypertensive treatment. At screening visit, all patients must have a blood pressure \<140/90 mmHg. * Other diseases: Medical history of inherited thrombophilias, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach). * Other conditions: Lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur or recent major general surgery (within 12 months before the Screening). 8. Study participant has received any stem cell treatment within 12 months before the first dose of the investigational product other than stem cells produced by Hope Biosciences. 9. The study participant has received an experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations) 10. Study participant has a laboratory abnormality during screening, including the following: * White blood cell count WBC \< 3.0 K/UL and \> 12.0 K/UL * Platelet count \< 80 K/UL and or \> 450 K/UL * Absolute neutrophil count \< 1.50 K/UL and or \> 7.50 K/UL * Alanine aminotransferase (ALT) of \> 75 U/L * Aspartate aminotransferase (AST) of \> 75 U/L * Hemoglobin (Hgb) \<11 G/DL or \>18 G/DL * Hematocrit (HCT) \<33% or \>54 % * Mean corpuscular volume (MCV) \< 75 FL or \>100 FL * Mean corpuscular hemoglobin (MCH) \<23 PG or \>36 PG * Mean corpuscular hemoglobin concentration (MCHC) \<30 G/DL or \> 37gG/DL * Red cell distribution width (RDW) \< 10% or \>14% * Abnormal laboratory results considered clinically significant by the principal investigator will exclude patients from participation in this investigation. 11. The study participant has any known ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, syphilis infections, hepatitis B surface antigen-positive, or hepatitis C PCR positivity. 12. The study participant is unlikely to complete the study or adhere to the study procedures. 13. The study participant has a previously diagnosed psychiatric condition that may affect self-assessments in the investigator's opinion. 14. Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days before the first dose of the investigational product. 15. Male study participants expect to donate sperm during the trial or within six months after the last dose. Female patients intend to donate eggs or have IVF treatment during the trial or within six months after the last dose. 16. Study participants who the Investigator determines to be unsuitable for study enrollment for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, those who have a prothrombotic condition, or who require persistent oxygen supplementation. 17. The subject has recently been diagnosed with an unstable Chronic obstructive pulmonary disease (COPD) as defined by patients who experience frequent or severe exacerbations and a faster decline in pulmonary function. 18. Subjects who have fatigue due to chronic kidney disease, iron deficiency anemia, B12 deficiency and other anemias will be excluded. 19. Any participant who has suicidal ideation at the screening visit will be excluded from this clinical trial. 20. Subjects with the following diseases must be excluded from participation in the trial. * chronic liver disease * pneumonia * history of chronic fatigue syndrome * subjects with fatigue symptoms due to fibromyalgia, arthritic disorders, inflammatory and rheumatological disorders * respiratory failure * emphysema * uncontrolled asthma * any subject requiring supplemental oxygen for any cause. * Acceptable reversible and permanent methods of birth control include: 1\. True sexual abstinence (abstaining from sexual activity during the entire period of risk). 2\. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS). 5. Condoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Physical Examination Results. - Skin | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system. |
| Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values with units of mL/min/1.73m\^2. |
| Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio |
| Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in Coagulation Panel values with units of seconds. |
| Changes in Physical Examination Results. - Cardiovascular | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Cardiovascular body system |
| Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system |
| Changes in Physical Examination Results. - Lymph Node | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Lymph Node |
| Changes in Physical Examination Results. - Musculoskeletal | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Musculoskeletal |
| Changes in Physical Examination Results. - Neurological | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Neurological |
| Changes in Physical Examination Results. - Respiratory | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Respiratory |
| Changes in Laboratory Values. - CBC (fL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit of fL. |
| Changes in Laboratory Values. - CBC (g/dL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit of g/dL. |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled no fatigue and the other end labeled worst fatigue. The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled no brain fog and the other end labeled worst brain fog. The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled no headache and the other end labeled worst headache. The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled no sleep disturbance and the other end labeled worst sleep disturbance. The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled no loss of taste and the other end labeled worst loss of taste. The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled no loss of smell and the other end labeled worst loss of smell. The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Baseline to Week 26 | Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled no fatigue and the other end labeled worst fatigue. The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Baseline to Week 26 | Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled no brain fog and the other end labeled worst brain fog. The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Baseline to Week 26 | Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled no headache and the other end labeled worst headache. The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled no sleep disturbance and the other end labeled worst sleep disturbance. The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled no loss of taste and the other end labeled worst loss of taste. The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste). |
| Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Baseline to Weeks 26 | Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled no loss of smell and the other end labeled worst loss of smell. The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell). |
| Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Baseline to Weeks 26 | Clinically significant changes in CBC values. |
| Changes in Laboratory Values. - CBC. (% of WBC) | Baseline to Weeks 26 | Clinically significant changes in CBC values. |
| Changes in Laboratory Values. - CBC (pg) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit of pg. |
| Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit of 10\^6 cells/uL. |
| Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC |
| Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count. |
| Changes in Laboratory Values. - CMP (g/dL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values. |
| Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds). |
| Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Baseline to Weeks 26 | Clinically significant changes in Respiratory Rate (breaths per minute) |
| Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Baseline to Weeks 26 | Clinically significant changes in Heart Rate (beats per minute) |
| Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Baseline to Week 10, End of Study at Weeks 26 | Clinically significant changes in Body Temperature (Celsius) |
| Changes in Vital Signs. - Blood Pressure (mmHg) | Baseline to Weeks 10, End of Study at Week 26 | Clinically significant changes in Blood Pressure. |
| Changes in Weight in kg. | Baseline to Weeks 10, End of Study at Week 26 | Change from baseline in Weight in kg. |
| Changes in Physical Examination Results. - Abdomen | Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26 | Clinically significant changes in physical examination results - Abdomen body system |
| Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL) |
| Changes in Laboratory Values. - CMP (U/L) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values with units of U/L. |
| Changes in Laboratory Values. - CMP (mg/dL) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values with units of mg/dL. |
| Changes in Laboratory Values. - CMP (mEq/L) | Baseline (Week 0), Week 10, and End of Study (Week 26) | Clinically significant changes in CMP values with units of mEq/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea) |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough). |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches). |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain). |
| Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. |
| Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. |
| Changes in Subject's Level of Depression - PHQ 9 Scale. | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) \[30\]. |
| Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. |
| Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model) | Baseline (Infusion 1) to Weeks 26 (End of Study) | Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HB-adMSCs HB-adMSCs (allogeneic) | 39 |
| Placebo Placebo comarator | 40 |
| Total | 79 |
Baseline characteristics
| Characteristic | HB-adMSCs | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 79 Participants | 40 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 10.9 | 41.5 years STANDARD_DEVIATION 10.81 | 42.4 years STANDARD_DEVIATION 10.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 61 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 170.76 centimeter STANDARD_DEVIATION 7.917 | 172.71 centimeter STANDARD_DEVIATION 9.177 | 174.62 centimeter |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 75 Participants | 37 Participants |
| Region of Enrollment United States | 39 participants | 79 participants | 40 participants |
| Sex: Female, Male Female | 21 Participants | 36 Participants | 15 Participants |
| Sex: Female, Male Male | 18 Participants | 43 Participants | 25 Participants |
| Weight | 79.35 kilograms STANDARD_DEVIATION 19.229 | 79.32 kilograms STANDARD_DEVIATION 17.193 | 79.28 kilograms STANDARD_DEVIATION 15.197 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 |
| other Total, other adverse events | 34 / 39 | 28 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled no brain fog and the other end labeled worst brain fog. The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) | -1.908 score on a scale (10 points total) | Standard Error 0.462 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model) | -1.736 score on a scale (10 points total) | Standard Error 0.493 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.802195% CI: [-1.54, 1.2]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model)
Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled no brain fog and the other end labeled worst brain fog. The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).
Time frame: Baseline to Week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 2 (Week 2) | -1.134 score on a scale (10 points total) | Standard Error 0.352 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 3 (Week 6) | -1.425 score on a scale (10 points total) | Standard Error 0.377 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 4 (Week 10) | -2.281 score on a scale (10 points total) | Standard Error 0.419 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | End of Study (Week 26) | -1.827 score on a scale (10 points total) | Standard Error 0.467 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | End of Study (Week 26) | -1.818 score on a scale (10 points total) | Standard Error 0.497 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 2 (Week 2) | -0.944 score on a scale (10 points total) | Standard Error 0.371 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 4 (Week 10) | -1.532 score on a scale (10 points total) | Standard Error 0.446 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model) | Infusion 3 (Week 6) | -0.837 score on a scale (10 points total) | Standard Error 0.402 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.989295% CI: [-1.38, 1.36]RMA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled no fatigue and the other end labeled worst fatigue. The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) | -2.376 score on a scale (10 points total) | Standard Error 0.496 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) | -2.430 score on a scale (10 points total) | Standard Error 0.529 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.941695% CI: [-1.42, 1.53]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model)
Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled no fatigue and the other end labeled worst fatigue. The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).
Time frame: Baseline to Week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 2 (Week 2) | -1.010 score on a scale (10 points total) | Standard Error 0.406 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 3 (Week 6) | -1.214 score on a scale (10 points total) | Standard Error 0.438 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | EOS (Week 26) | -2.330 score on a scale (10 points total) | Standard Error 0.49 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 4 (Week 10) | -2.010 score on a scale (10 points total) | Standard Error 0.463 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | EOS (Week 26) | -2.492 score on a scale (10 points total) | Standard Error 0.522 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 2 (Week 2) | -0.772 score on a scale (10 points total) | Standard Error 0.428 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 3 (Week 6) | -1.439 score on a scale (10 points total) | Standard Error 0.468 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model) | Infusion 4 (Week 10) | -2.018 score on a scale (10 points total) | Standard Error 0.494 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.82495% CI: [-1.29, 1.61]RMA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled no headache and the other end labeled worst headache. The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) | -0.755 score on a scale (10 points total) | Standard Error 0.348 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model) | -1.154 score on a scale (10 points total) | Standard Error 0.371 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.441795% CI: [-0.63, 1.43]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model)
Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled no headache and the other end labeled worst headache. The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).
Time frame: Baseline to Week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 2 (Week 2) | -0.362 score on a scale (10 points total) | Standard Error 0.4 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 3 (Week 6) | -0.504 score on a scale (10 points total) | Standard Error 0.388 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 4 (Week 10) | -0.696 score on a scale (10 points total) | Standard Error 0.385 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | End Of Study (Week 26) | -0.741 score on a scale (10 points total) | Standard Error 0.346 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | End Of Study (Week 26) | -1.181 score on a scale (10 points total) | Standard Error 0.369 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 2 (Week 2) | -0.548 score on a scale (10 points total) | Standard Error 0.422 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 4 (Week 10) | -0.870 score on a scale (10 points total) | Standard Error 0.411 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model) | Infusion 3 (Week 6) | -0.648 score on a scale (10 points total) | Standard Error 0.414 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.395295% CI: [-0.59, 1.47]RMA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled no loss of smell and the other end labeled worst loss of smell. The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) | -0.623 score on a scale (10 points total) | Standard Error 0.241 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model) | -0.463 score on a scale (10 points total) | Standard Error 0.258 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.658995% CI: [-0.88, 0.56]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model)
Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled no loss of smell and the other end labeled worst loss of smell. The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 2 (Week 2) | -0.336 score on a scale (10 points total) | Standard Error 0.273 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 3 (Week 6) | -0.112 score on a scale (10 points total) | Standard Error 0.264 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 4 (Week 10) | -0.678 score on a scale (10 points total) | Standard Error 0.242 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | End Of Study (Week 26) | -0.653 score on a scale (10 points total) | Standard Error 0.241 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | End Of Study (Week 26) | -0.438 score on a scale (10 points total) | Standard Error 0.256 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 2 (Week 2) | 0.617 score on a scale (10 points total) | Standard Error 0.288 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 4 (Week 10) | -0.196 score on a scale (10 points total) | Standard Error 0.258 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model) | Infusion 3 (Week 6) | -0.013 score on a scale (10 points total) | Standard Error 0.281 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.548595% CI: [-0.93, 0.5]RMA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled no loss of taste and the other end labeled worst loss of taste. The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) | -0.509 score on a scale (10 points total) | Standard Error 0.314 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model) | -0.462 score on a scale (10 points total) | Standard Error 0.335 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.9295% CI: [-0.98, 0.89]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model)
Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled no loss of taste and the other end labeled worst loss of taste. The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 2 (Week 2) | -0.450 score on a scale (10 points total) | Standard Error 0.234 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 4 (Week 10) | -0.654 score on a scale (10 points total) | Standard Error 0.339 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 3 (Week 6) | -0.372 score on a scale (10 points total) | Standard Error 0.325 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | End of Study (Week 26) | -0.569 score on a scale (10 points total) | Standard Error 0.318 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | End of Study (Week 26) | -0.408 score on a scale (10 points total) | Standard Error 0.339 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 2 (Week 2) | 0.235 score on a scale (10 points total) | Standard Error 0.247 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 3 (Week 6) | 0.523 score on a scale (10 points total) | Standard Error 0.346 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model) | Infusion 4 (Week 10) | -0.365 score on a scale (10 points total) | Standard Error 0.362 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.731895% CI: [-1.1, 0.78]RMA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled no sleep disturbance and the other end labeled worst sleep disturbance. The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).
Time frame: Baseline to Weeks 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) | -2.005 score on a scale (10 points total) | Standard Error 0.486 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model) | -2.547 score on a scale (10 points total) | Standard Error 0.518 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.45595% CI: [-0.9, 1.98]ANCOVA
Primary
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model)
Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled no sleep disturbance and the other end labeled worst sleep disturbance. The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 3 (Week 6) | -1.845 score on a scale (10 points total) | Standard Error 0.462 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 2 (Week 2) | -1.331 score on a scale (10 points total) | Standard Error 0.34 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 4 (Week 10) | -2.028 score on a scale (10 points total) | Standard Error 0.466 |
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | End of Study (Week 26) | -2.016 score on a scale (10 points total) | Standard Error 0.479 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | End of Study (Week 26) | -2.551 score on a scale (10 points total) | Standard Error 0.51 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 4 (Week 10) | -2.095 score on a scale (10 points total) | Standard Error 0.497 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 2 (Week 2) | -0.730 score on a scale (10 points total) | Standard Error 0.357 |
| Placebo | Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model) | Infusion 3 (Week 6) | -1.813 score on a scale (10 points total) | Standard Error 0.492 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.450495% CI: [-0.87, 1.94]RMA
Primary
Changes From Baseline in Vital Signs. - Body Temperature (Celsius)
Clinically significant changes in Body Temperature (Celsius)
Time frame: Baseline to Week 10, End of Study at Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 2 (Week 2) | 0.01 degrees Celsius | Standard Error 0.047 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 4 (Week 10) | 0.01 degrees Celsius | Standard Error 0.051 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 3 (Week 6) | 0.05 degrees Celsius | Standard Error 0.05 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | End of Study (Week 26) | -0.08 degrees Celsius | Standard Error 0.052 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Baseline | 36.63 degrees Celsius | Standard Error 0.043 |
| Placebo | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | End of Study (Week 26) | -0.05 degrees Celsius | Standard Error 0.053 |
| Placebo | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Baseline | 36.70 degrees Celsius | Standard Error 0.039 |
| Placebo | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 2 (Week 2) | -0.04 degrees Celsius | Standard Error 0.04 |
| Placebo | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 3 (Week 6) | -0.03 degrees Celsius | Standard Error 0.05 |
| Placebo | Changes From Baseline in Vital Signs. - Body Temperature (Celsius) | Infusion 4 (Week 10) | -0.05 degrees Celsius | Standard Error 0.038 |
Primary
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute)
Clinically significant changes in Heart Rate (beats per minute)
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 2 (Week 2) | -0.6 beats per minute | Standard Error 1.67 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 4 (Week 10) | -3.5 beats per minute | Standard Error 1.91 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 3 (Week 6) | 0.5 beats per minute | Standard Error 2.07 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | End of Study (Week 26) | -4.2 beats per minute | Standard Error 2.09 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Baseline | 73.9 beats per minute | Standard Error 1.88 |
| Placebo | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | End of Study (Week 26) | 2.4 beats per minute | Standard Error 1.54 |
| Placebo | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Baseline | 70.0 beats per minute | Standard Error 1.76 |
| Placebo | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 2 (Week 2) | 3.6 beats per minute | Standard Error 1.65 |
| Placebo | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 3 (Week 6) | 6.1 beats per minute | Standard Error 2.14 |
| Placebo | Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute) | Infusion 4 (Week 10) | 3.2 beats per minute | Standard Error 1.65 |
Primary
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute)
Clinically significant changes in Respiratory Rate (breaths per minute)
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Baseline | 17.0 breaths/min | Standard Error 0.16 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 2 (Week 2) | 0.1 breaths/min | Standard Error 0.19 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 3 (Week 6) | -0.1 breaths/min | Standard Error 0.21 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | End of Study (Week 26) | 0.1 breaths/min | Standard Error 0.2 |
| HB-adMSCs | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 4 (Week 10) | -0.3 breaths/min | Standard Error 0.15 |
| Placebo | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 3 (Week 6) | 0.2 breaths/min | Standard Error 0.19 |
| Placebo | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Baseline | 16.8 breaths/min | Standard Error 0.16 |
| Placebo | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 4 (Week 10) | -0.1 breaths/min | Standard Error 0.22 |
| Placebo | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | Infusion 2 (Week 2) | 0.2 breaths/min | Standard Error 0.22 |
| Placebo | Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute) | End of Study (Week 26) | 0.3 breaths/min | Standard Error 0.24 |
Primary
Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC)
Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW Baseline/Infusion 1 (Week 0) | 12.58 % difference in volume and size of RBC | Standard Error 0.107 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW Infusion 4 (Week 10) | -0.03 % difference in volume and size of RBC | Standard Error 0.071 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW End of Study (Week 26) | 0.01 % difference in volume and size of RBC | Standard Error 0.096 |
| Placebo | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW Baseline/Infusion 1 (Week 0) | 12.58 % difference in volume and size of RBC | Standard Error 0.104 |
| Placebo | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW Infusion 4 (Week 10) | -0.08 % difference in volume and size of RBC | Standard Error 0.1 |
| Placebo | Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC) | RDW End of Study (Week 26) | 0.01 % difference in volume and size of RBC | Standard Error 0.06 |
Primary
Changes in Laboratory Values. - CBC (fL)
Changes from baseline in CBC laboratory values with unit of fL.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (fL) | MCV Baseline/Infusion 1 (Week 0) | 89.68 fL | Standard Error 0.575 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (fL) | MCV Infusion 4 (Week 10) | 0.14 fL | Standard Error 0.204 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (fL) | MCV End of Study (Week 26) | 0.42 fL | Standard Error 0.35 |
| Placebo | Changes in Laboratory Values. - CBC (fL) | MCV Baseline/Infusion 1 (Week 0) | 90.00 fL | Standard Error 0.485 |
| Placebo | Changes in Laboratory Values. - CBC (fL) | MCV Infusion 4 (Week 10) | -0.29 fL | Standard Error 0.327 |
| Placebo | Changes in Laboratory Values. - CBC (fL) | MCV End of Study (Week 26) | 0.21 fL | Standard Error 0.318 |
Primary
Changes in Laboratory Values. - CBC (g/dL)
Changes from baseline in CBC laboratory values with unit of g/dL.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | MCHC Baseline/Infusion 1 (Week 0) | 33.90 g/dL | Standard Error 0.155 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | MCHC Infusion 4 (Week 10) | -0.05 g/dL | Standard Error 0.143 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | MCHC End of Study (Week 26) | -0.24 g/dL | Standard Error 0.16 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin Infusion 4 (Week 10) | -0.11 g/dL | Standard Error 0.133 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin End of Study (Week 26) | -0.13 g/dL | Standard Error 0.131 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin Baseline/Infusion 1 (Week 0) | 14.35 g/dL | Standard Error 0.235 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin End of Study (Week 26) | 0.13 g/dL | Standard Error 0.158 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | MCHC Baseline/Infusion 1 (Week 0) | 34.05 g/dL | Standard Error 0.138 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin Infusion 4 (Week 10) | 0.13 g/dL | Standard Error 0.102 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | MCHC Infusion 4 (Week 10) | 0.04 g/dL | Standard Error 0.185 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | Hemoglobin Baseline/Infusion 1 (Week 0) | 14.34 g/dL | Standard Error 0.211 |
| Placebo | Changes in Laboratory Values. - CBC (g/dL) | MCHC End of Study (Week 26) | -0.23 g/dL | Standard Error 0.245 |
Primary
Changes in Laboratory Values. - CBC (% of Total Blood Cell Count)
Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit Baseline/Infusion 1 (Week 0) | 42.33 % of Total Blood Cell Count | Standard Error 0.652 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit Infusion 4 (Week 10) | -0.27 % of Total Blood Cell Count | Standard Error 0.405 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit End of Study (Week 26) | -0.11 % of Total Blood Cell Count | Standard Error 0.444 |
| Placebo | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit Baseline/Infusion 1 (Week 0) | 42.11 % of Total Blood Cell Count | Standard Error 0.6 |
| Placebo | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit Infusion 4 (Week 10) | 0.32 % of Total Blood Cell Count | Standard Error 0.336 |
| Placebo | Changes in Laboratory Values. - CBC (% of Total Blood Cell Count) | Hematocrit End of Study (Week 26) | 0.64 % of Total Blood Cell Count | Standard Error 0.443 |
Primary
Changes in Laboratory Values. - CBC. (% of WBC)
Clinically significant changes in CBC values.
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils Baseline/Infusion 1 (Week 0) | 0.91 % of WBC | Standard Error 0.135 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils End of Study (Week 26) | 0.26 % of WBC | Standard Error 0.326 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils End of Study (Week 26) | 0.06 % of WBC | Standard Error 1.681 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes Baseline/Infusion 1 (Week 0) | 34.29 % of WBC | Standard Error 1.213 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils End of Study (Week 26) | -0.08 % of WBC | Standard Error 0.197 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes Infusion 4 (Week 10) | -0.49 % of WBC | Standard Error 1.662 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils Infusion 4 (Week 10) | -0.21 % of WBC | Standard Error 0.144 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes End of Study (Week 26) | -0.56 % of WBC | Standard Error 1.379 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils Baseline/Infusion 1 (Week 0) | 1.99 % of WBC | Standard Error 0.252 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes Baseline/Infusion 1 (Week 0) | 7.79 % of WBC | Standard Error 0.545 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils Baseline/Infusion 1 (Week 0) | 54.95 % of WBC | Standard Error 1.162 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes Infusion 4 (Week 10) | -0.29 % of WBC | Standard Error 0.426 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils Infusion 4 (Week 10) | -0.11 % of WBC | Standard Error 0.243 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes End of Study (Week 26) | 0.24 % of WBC | Standard Error 0.642 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils Infusion 4 (Week 10) | 1.05 % of WBC | Standard Error 1.85 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes End of Study (Week 26) | 0.54 % of WBC | Standard Error 0.472 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils Infusion 4 (Week 10) | 1.44 % of WBC | Standard Error 2.131 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils End of Study (Week 26) | 3.03 % of WBC | Standard Error 1.675 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils Baseline/Infusion 1 (Week 0) | 1.07 % of WBC | Standard Error 0.168 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Neutrophils Baseline/Infusion 1 (Week 0) | 52.37 % of WBC | Standard Error 1.508 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils Infusion 4 (Week 10) | -0.08 % of WBC | Standard Error 0.188 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Basophils End of Study (Week 26) | 0.02 % of WBC | Standard Error 0.136 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils Baseline/Infusion 1 (Week 0) | 3.00 % of WBC | Standard Error 0.468 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils Infusion 4 (Week 10) | -0.52 % of WBC | Standard Error 0.461 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Eosinophils End of Study (Week 26) | -0.41 % of WBC | Standard Error 0.421 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes Baseline/Infusion 1 (Week 0) | 36.20 % of WBC | Standard Error 1.239 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes Infusion 4 (Week 10) | -1.46 % of WBC | Standard Error 1.548 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Lymphocytes End of Study (Week 26) | -3.25 % of WBC | Standard Error 1.444 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes Baseline/Infusion 1 (Week 0) | 7.27 % of WBC | Standard Error 0.382 |
| Placebo | Changes in Laboratory Values. - CBC. (% of WBC) | Monocytes Infusion 4 (Week 10) | 0.61 % of WBC | Standard Error 0.583 |
Primary
Changes in Laboratory Values. - CBC (pg)
Changes from baseline in CBC laboratory values with unit of pg.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (pg) | MCH Baseline/Infusion 1 (Week 0) | 30.40 pg | Standard Error 0.242 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (pg) | MCH Infusion 4 (Week 10) | -0.00 pg | Standard Error 0.134 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (pg) | MCH End of Study (Week 26) | -0.06 pg | Standard Error 0.169 |
| Placebo | Changes in Laboratory Values. - CBC (pg) | MCH Baseline/Infusion 1 (Week 0) | 30.64 pg | Standard Error 0.226 |
| Placebo | Changes in Laboratory Values. - CBC (pg) | MCH Infusion 4 (Week 10) | -0.06 pg | Standard Error 0.133 |
| Placebo | Changes in Laboratory Values. - CBC (pg) | MCH End of Study (Week 26) | -0.14 pg | Standard Error 0.201 |
Primary
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL)
Clinically significant changes in CBC values.
Time frame: Baseline to Weeks 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes Baseline/Infusion 1 (Week 0) | 1.9733 x10^3 cells/uL | Standard Error 0.10847 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet Infusion 4 (Week 10) | -11.9 x10^3 cells/uL | Standard Error 5.77 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC End of Study (Week 26) | 0.30 x10^3 cells/uL | Standard Error 0.261 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils Baseline/Infusion 1 (Week 0) | 0.0454 x10^3 cells/uL | Standard Error 0.00531 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils Infusion 4 (Week 10) | 0.0017 x10^3 cells/uL | Standard Error 0.00344 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils End of Study (Week 26) | -0.0019 x10^3 cells/uL | Standard Error 0.00407 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils Baseline/Infusion 1 (Week 0) | 0.1177 x10^3 cells/uL | Standard Error 0.01258 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils Infusion 4 (Week 10) | 0.0006 x10^3 cells/uL | Standard Error 0.00903 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils End of Study (Week 26) | 0.0105 x10^3 cells/uL | Standard Error 0.01051 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes Infusion 4 (Week 10) | -0.0623 x10^3 cells/uL | Standard Error 0.07443 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes End of Study (Week 26) | 0.0851 x10^3 cells/uL | Standard Error 0.0916 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes Baseline/Infusion 1 (Week 0) | 0.4877 x10^3 cells/uL | Standard Error 0.02321 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes Infusion 4 (Week 10) | -0.0269 x10^3 cells/uL | Standard Error 0.02181 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes End of Study (Week 26) | 0.0324 x10^3 cells/uL | Standard Error 0.02022 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils Baseline/Infusion 1 (Week 0) | 3.4426 x10^3 cells/uL | Standard Error 0.18489 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils Infusion 4 (Week 10) | 0.0900 x10^3 cells/uL | Standard Error 0.29868 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils End of Study (Week 26) | 0.1785 x10^3 cells/uL | Standard Error 0.1943 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet Baseline/Infusion 1 (Week 0) | 269.1 x10^3 cells/uL | Standard Error 8.73 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet End of Study (Week 26) | -2.1 x10^3 cells/uL | Standard Error 5.37 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC Baseline/Infusion 1 (Week 0) | 6.08 x10^3 cells/uL | Standard Error 0.279 |
| HB-adMSCs | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC Infusion 4 (Week 10) | 0.01 x10^3 cells/uL | Standard Error 0.311 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet Infusion 4 (Week 10) | 2.3 x10^3 cells/uL | Standard Error 6.18 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes Baseline/Infusion 1 (Week 0) | 1.8820 x10^3 cells/uL | Standard Error 0.09517 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet Baseline/Infusion 1 (Week 0) | 249.4 x10^3 cells/uL | Standard Error 8.25 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes End of Study (Week 26) | -0.0777 x10^3 cells/uL | Standard Error 0.07055 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC Infusion 4 (Week 10) | 0.02 x10^3 cells/uL | Standard Error 0.188 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils Infusion 4 (Week 10) | 0.0591 x10^3 cells/uL | Standard Error 0.1594 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC End of Study (Week 26) | -0.04 x10^3 cells/uL | Standard Error 0.183 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes Baseline/Infusion 1 (Week 0) | 0.4663 x10^3 cells/uL | Standard Error 0.01919 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils Baseline/Infusion 1 (Week 0) | 0.0415 x10^3 cells/uL | Standard Error 0.00315 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | WBC Baseline/Infusion 1 (Week 0) | 5.82 x10^3 cells/uL | Standard Error 0.255 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils Infusion 4 (Week 10) | 0.0047 x10^3 cells/uL | Standard Error 0.00327 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes Infusion 4 (Week 10) | 0.0084 x10^3 cells/uL | Standard Error 0.01992 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Basophils End of Study (Week 26) | 0.0037 x10^3 cells/uL | Standard Error 0.00344 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils End of Study (Week 26) | 0.0883 x10^3 cells/uL | Standard Error 0.15998 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils Baseline/Infusion 1 (Week 0) | 0.1965 x10^3 cells/uL | Standard Error 0.03371 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Monocytes End of Study (Week 26) | -0.0040 x10^3 cells/uL | Standard Error 0.01791 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils Infusion 4 (Week 10) | -0.0356 x10^3 cells/uL | Standard Error 0.0241 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Platelet End of Study (Week 26) | 2.1 x10^3 cells/uL | Standard Error 5.94 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Eosinophils End of Study (Week 26) | -0.0373 x10^3 cells/uL | Standard Error 0.03355 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Neutrophils Baseline/Infusion 1 (Week 0) | 3.2103 x10^3 cells/uL | Standard Error 0.16672 |
| Placebo | Changes in Laboratory Values. - CBC. (x10^3 Cells/uL) | Absolute Lymphocytes Infusion 4 (Week 10) | -0.0203 x10^3 cells/uL | Standard Error 0.06454 |
Primary
Changes in Laboratory Values. - CBC (x10^6 Cells/uL)
Changes from baseline in CBC laboratory values with unit of 10\^6 cells/uL.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC Baseline/Infusion 1 (Week 0) | 4.729 10^6 cells/uL | Standard Error 0.0822 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC Infusion 4 (Week 10) | -0.039 10^6 cells/uL | Standard Error 0.046 |
| HB-adMSCs | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC End of Study (Week 26) | -0.033 10^6 cells/uL | Standard Error 0.0507 |
| Placebo | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC Baseline/Infusion 1 (Week 0) | 4.690 10^6 cells/uL | Standard Error 0.0804 |
| Placebo | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC Infusion 4 (Week 10) | 0.052 10^6 cells/uL | Standard Error 0.0384 |
| Placebo | Changes in Laboratory Values. - CBC (x10^6 Cells/uL) | RBC End of Study (Week 26) | 0.062 10^6 cells/uL | Standard Error 0.0547 |
Primary
Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio)
Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat Baseline/Infusion 1 (Week 0) | 16.5 Ratio | Standard Error 0.97 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat Infusion 4 (Week 10) | -0.0 Ratio | Standard Error 0.64 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat End of Study (Week 26) | 0.7 Ratio | Standard Error 0.82 |
| Placebo | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat Baseline/Infusion 1 (Week 0) | 16.4 Ratio | Standard Error 0.68 |
| Placebo | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat Infusion 4 (Week 10) | -0.1 Ratio | Standard Error 0.68 |
| Placebo | Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio) | Calc BUN/Creat End of Study (Week 26) | -0.4 Ratio | Standard Error 0.75 |
Primary
Changes in Laboratory Values. - CMP (g/dL)
Clinically significant changes in CMP values.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Albumin Baseline/Infusion 1 (Week 0) | 4.65 g/dL | Standard Error 0.052 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Albumin Infusion 4 (Week 10) | -0.11 g/dL | Standard Error 0.039 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Albumin End of Study (Week 26) | -0.13 g/dL | Standard Error 0.039 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin Infusion 4 (Week 10) | -0.08 g/dL | Standard Error 0.045 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin End of Study (Week 26) | -0.07 g/dL | Standard Error 0.061 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Protein Baseline/Infusion 1 (Week 0) | 7.28 g/dL | Standard Error 0.113 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Protein Infusion 4 (Week 10) | -0.19 g/dL | Standard Error 0.068 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Protein End of Study (Week 26) | -0.20 g/dL | Standard Error 0.072 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin Baseline/Infusion 1 (Week 0) | 2.63 g/dL | Standard Error 0.125 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin End of Study (Week 26) | -0.05 g/dL | Standard Error 0.047 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Albumin Baseline/Infusion 1 (Week 0) | 4.63 g/dL | Standard Error 0.045 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Albumin End of Study (Week 26) | -0.02 g/dL | Standard Error 0.052 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Albumin Infusion 4 (Week 10) | -0.02 g/dL | Standard Error 0.044 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Protein Baseline/Infusion 1 (Week 0) | 7.09 g/dL | Standard Error 0.068 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin Baseline/Infusion 1 (Week 0) | 2.46 g/dL | Standard Error 0.063 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Protein End of Study (Week 26) | -0.07 g/dL | Standard Error 0.075 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Calc Globulin Infusion 4 (Week 10) | 0.03 g/dL | Standard Error 0.043 |
| Placebo | Changes in Laboratory Values. - CMP (g/dL) | Protein Infusion 4 (Week 10) | 0.02 g/dL | Standard Error 0.057 |
Primary
Changes in Laboratory Values. - CMP (mEq/L)
Clinically significant changes in CMP values with units of mEq/L.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Chloride Infusion 4 (Week 10) | 0.2 mEq/L | Standard Error 0.45 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Potassium Baseline/Infusion 1 (Week 0) | 4.40 mEq/L | Standard Error 0.059 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide Baseline/Infusion 1 (Week 0) | 24.7 mEq/L | Standard Error 0.33 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Potassium Infusion 4 (Week 10) | -0.08 mEq/L | Standard Error 0.067 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Sodium Baseline/Infusion 1 (Week 0) | 140.2 mEq/L | Standard Error 0.38 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Chloride Baseline/Infusion 1 (Week 0) | 103.3 mEq/L | Standard Error 0.45 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Sodium Infusion 4 (Week 10) | -0.1 mEq/L | Standard Error 0.45 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide Infusion 4 (Week 10) | -0.2 mEq/L | Standard Error 0.39 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Sodium End of Study (Week 26) | 0.2 mEq/L | Standard Error 0.51 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Chloride End of Study (Week 26) | 0.6 mEq/L | Standard Error 0.42 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide End of Study (Week 26) | 0.0 mEq/L | Standard Error 0.47 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mEq/L) | Potassium End of Study (Week 26) | -0.14 mEq/L | Standard Error 0.08 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide End of Study (Week 26) | -0.4 mEq/L | Standard Error 0.45 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Chloride Baseline/Infusion 1 (Week 0) | 104.1 mEq/L | Standard Error 0.35 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Chloride Infusion 4 (Week 10) | -0.3 mEq/L | Standard Error 0.37 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Chloride End of Study (Week 26) | -0.3 mEq/L | Standard Error 0.4 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide Baseline/Infusion 1 (Week 0) | 25.2 mEq/L | Standard Error 0.35 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Carbon Dioxide Infusion 4 (Week 10) | -0.3 mEq/L | Standard Error 0.43 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Potassium End of Study (Week 26) | -0.11 mEq/L | Standard Error 0.118 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Potassium Baseline/Infusion 1 (Week 0) | 4.44 mEq/L | Standard Error 0.086 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Sodium Baseline/Infusion 1 (Week 0) | 141.1 mEq/L | Standard Error 0.31 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Sodium Infusion 4 (Week 10) | 0.2 mEq/L | Standard Error 0.5 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Sodium End of Study (Week 26) | -0.5 mEq/L | Standard Error 0.49 |
| Placebo | Changes in Laboratory Values. - CMP (mEq/L) | Potassium Infusion 4 (Week 10) | -0.08 mEq/L | Standard Error 0.128 |
Primary
Changes in Laboratory Values. - CMP (mg/dL)
Clinically significant changes in CMP values with units of mg/dL.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Calcium Infusion 4 (Week 10) | -0.04 mg/dL | Standard Error 0.099 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine End of Study (Week 26) | -0.012 mg/dL | Standard Error 0.019 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin Infusion 4 (Week 10) | -0.05 mg/dL | Standard Error 0.035 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Glucose Baseline/Infusion 1 (Week 0) | 98.5 mg/dL | Standard Error 6.43 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Calcium End of Study (Week 26) | -0.06 mg/dL | Standard Error 0.098 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Glucose Infusion 4 (Week 10) | -5.0 mg/dL | Standard Error 6.4 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Calcium Baseline/Infusion 1 (Week 0) | 9.56 mg/dL | Standard Error 0.085 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Glucose End of Study (Week 26) | -2.9 mg/dL | Standard Error 4.92 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine Baseline/Infusion 1 (Week 0) | 0.885 mg/dL | Standard Error 0.0337 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen Baseline/Infusion 1 (Week 0) | 13.9 mg/dL | Standard Error 0.61 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin End of Study (Week 26) | -0.12 mg/dL | Standard Error 0.032 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen Infusion 4 (Week 10) | -0.3 mg/dL | Standard Error 0.54 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine Infusion 4 (Week 10) | -0.022 mg/dL | Standard Error 0.0146 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen End of Study (Week 26) | 0.4 mg/dL | Standard Error 0.67 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin Baseline/Infusion 1 (Week 0) | 0.52 mg/dL | Standard Error 0.029 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen End of Study (Week 26) | -0.2 mg/dL | Standard Error 0.62 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin Baseline/Infusion 1 (Week 0) | 0.50 mg/dL | Standard Error 0.043 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin Infusion 4 (Week 10) | 0.03 mg/dL | Standard Error 0.034 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Bilirubin End of Study (Week 26) | -0.01 mg/dL | Standard Error 0.047 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Calcium Baseline/Infusion 1 (Week 0) | 9.54 mg/dL | Standard Error 0.055 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Calcium Infusion 4 (Week 10) | -0.01 mg/dL | Standard Error 0.058 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Calcium End of Study (Week 26) | -0.03 mg/dL | Standard Error 0.065 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine Baseline/Infusion 1 (Week 0) | 0.872 mg/dL | Standard Error 0.029 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine Infusion 4 (Week 10) | -0.010 mg/dL | Standard Error 0.0103 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Creatinine End of Study (Week 26) | 0.014 mg/dL | Standard Error 0.0106 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Glucose Baseline/Infusion 1 (Week 0) | 94.2 mg/dL | Standard Error 1.93 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Glucose Infusion 4 (Week 10) | 0.7 mg/dL | Standard Error 2.35 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Glucose End of Study (Week 26) | 2.0 mg/dL | Standard Error 1.41 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen Baseline/Infusion 1 (Week 0) | 13.8 mg/dL | Standard Error 0.51 |
| Placebo | Changes in Laboratory Values. - CMP (mg/dL) | Blood Urea Nitrogen Infusion 4 (Week 10) | -0.1 mg/dL | Standard Error 0.64 |
Primary
Changes in Laboratory Values. - CMP (mL/Min/1.73m^2)
Clinically significant changes in CMP values with units of mL/min/1.73m\^2.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate Baseline/Infusion 1 (Week 0) | 97.6 mL/min/1.73m^2 | Standard Error 2.45 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate Infusion 4 (Week 10) | 1.8 mL/min/1.73m^2 | Standard Error 1.54 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate End of Study (Week 26) | 0.7 mL/min/1.73m^2 | Standard Error 1.88 |
| Placebo | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate Baseline/Infusion 1 (Week 0) | 101.1 mL/min/1.73m^2 | Standard Error 2.06 |
| Placebo | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate Infusion 4 (Week 10) | 0.9 mL/min/1.73m^2 | Standard Error 1.1 |
| Placebo | Changes in Laboratory Values. - CMP (mL/Min/1.73m^2) | Estimated Glomerular Filtration Rate End of Study (Week 26) | -1.2 mL/min/1.73m^2 | Standard Error 1.27 |
Primary
Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)
Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio Baseline/Infusion 1 (Week 0) | 1.86 Ratio | Standard Error 0.057 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio End of Study (Week 26) | 0.04 Ratio | Standard Error 0.053 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio Infusion 4 (Week 10) | 0.02 Ratio | Standard Error 0.044 |
| Placebo | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio Baseline/Infusion 1 (Week 0) | 1.94 Ratio | Standard Error 0.06 |
| Placebo | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio Infusion 4 (Week 10) | -0.03 Ratio | Standard Error 0.046 |
| Placebo | Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL) | Calc A/G Ratio End of Study (Week 26) | 0.03 Ratio | Standard Error 0.043 |
Primary
Changes in Laboratory Values. - CMP (U/L)
Clinically significant changes in CMP values with units of U/L.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase Baseline/Infusion 1 (Week 0) | 66.9 U/L | Standard Error 2.31 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase Infusion 4 (Week 10) | -3.2 U/L | Standard Error 1.51 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase End of Study (Week 26) | -4.1 U/L | Standard Error 1.56 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase Baseline/Infusion 1 (Week 0) | 25.15 U/L | Standard Error 1.836 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase Infusion 4 (Week 10) | -5.14 U/L | Standard Error 1.272 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase End of Study (Week 26) | 0.26 U/L | Standard Error 3.321 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase Baseline/Infusion 1 (Week 0) | 23.8 U/L | Standard Error 1.63 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase Infusion 4 (Week 10) | -2.9 U/L | Standard Error 1.56 |
| HB-adMSCs | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase End of Study (Week 26) | -0.7 U/L | Standard Error 2.25 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase Infusion 4 (Week 10) | 1.5 U/L | Standard Error 1.17 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase End of Study (Week 26) | 2.00 U/L | Standard Error 1.211 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase Infusion 4 (Week 10) | 0.1 U/L | Standard Error 1.29 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase Baseline/Infusion 1 (Week 0) | 74.5 U/L | Standard Error 3.42 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alkaline Phosphatase End of Study (Week 26) | -0.5 U/L | Standard Error 1.87 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase Baseline/Infusion 1 (Week 0) | 20.7 U/L | Standard Error 0.96 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase Baseline/Infusion 1 (Week 0) | 21.28 U/L | Standard Error 1.718 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Aspartate Aminotransferase End of Study (Week 26) | 0.6 U/L | Standard Error 1.09 |
| Placebo | Changes in Laboratory Values. - CMP (U/L) | Alanine aminotransferase Infusion 4 (Week 10) | 2.81 U/L | Standard Error 1.353 |
Primary
Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds
Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR Baseline/Infusion 1 (Week 0) | 0.99 Ratio | Standard Error 0.01 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR Infusion 4 (Week 10) | -0.01 Ratio | Standard Error 0.008 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR End of Study (Week 26) | 0.00 Ratio | Standard Error 0.011 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR Baseline/Infusion 1 (Week 0) | 0.97 Ratio | Standard Error 0.011 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR Infusion 4 (Week 10) | 0.01 Ratio | Standard Error 0.01 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds | INR End of Study (Week 26) | -0.01 Ratio | Standard Error 0.013 |
Primary
Changes in Laboratory Values. - Coagulation Panel. (Seconds)
Clinically significant changes in Coagulation Panel values with units of seconds.
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time Baseline/Infusion 1 (Week 0) | 13.42 seconds | Standard Error 0.092 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time Infusion 4 (Week 10) | -0.11 seconds | Standard Error 0.057 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time End of Study (Week 26) | -0.12 seconds | Standard Error 0.115 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT Baseline/Infusion 1 (Week 0) | 29.36 seconds | Standard Error 0.486 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT Infusion 4 (Week 10) | -0.54 seconds | Standard Error 0.302 |
| HB-adMSCs | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT End of Study (Week 26) | -0.48 seconds | Standard Error 0.261 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT Infusion 4 (Week 10) | -0.51 seconds | Standard Error 0.198 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time Baseline/Infusion 1 (Week 0) | 13.27 seconds | Standard Error 0.097 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT Baseline/Infusion 1 (Week 0) | 29.93 seconds | Standard Error 0.416 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time Infusion 4 (Week 10) | 0.05 seconds | Standard Error 0.081 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | PTT End of Study (Week 26) | -0.73 seconds | Standard Error 0.238 |
| Placebo | Changes in Laboratory Values. - Coagulation Panel. (Seconds) | Prothrombin Time End of Study (Week 26) | -0.05 seconds | Standard Error 0.085 |
Primary
Changes in Physical Examination Results. - Abdomen
Clinically significant changes in physical examination results - Abdomen body system
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Normal | 36 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Normal | 38 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Abnormal | 2 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Baseline/Infusion 1 (Week 0) | Normal | 38 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 3 (Week 6) | Normal | 34 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Abdomen | Infusion 4 (Week 10) | Normal | 32 Participants |
Primary
Changes in Physical Examination Results. - Cardiovascular
Clinically significant changes in physical examination results - Cardiovascular body system
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Normal | 38 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Normal | 32 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Abnormal | 2 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 3 (Week 6) | Normal | 33 Participants |
| Placebo | Changes in Physical Examination Results. - Cardiovascular | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
Primary
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat
Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Normal | 36 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Normal | 40 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Normal | 32 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Normal | 35 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
Primary
Changes in Physical Examination Results. - Lymph Node
Clinically significant changes in physical examination results - Lymph Node
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Normal | 40 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Normal | 35 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Normal | 32 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Lymph Node | End of Study (Week 26) | Abnormal | 0 Participants |
Primary
Changes in Physical Examination Results. - Musculoskeletal
Clinically significant changes in physical examination results - Musculoskeletal
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Abnormal | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Abnormal | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Normal | 33 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Abnormal | 2 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Normal | 40 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Normal | 32 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Normal | 35 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Musculoskeletal | Infusion 3 (Week 6) | Normal | 34 Participants |
Primary
Changes in Physical Examination Results. - Neurological
Clinically significant changes in physical examination results - Neurological
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Abnormal | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Normal | 31 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Abnormal | 9 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Abnormal | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Normal | 31 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Normal | 32 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Abnormal | 3 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Abnormal | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Baseline/ Infusion 1 | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Normal | 35 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Normal | 31 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Neurological | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
Primary
Changes in Physical Examination Results. - Respiratory
Clinically significant changes in physical examination results - Respiratory
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Normal | 38 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Normal | 36 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Normal | 35 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Normal | 31 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Normal | 29 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 2 (Week 2) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Respiratory | Infusion 4 (Week 10) | Abnormal | 1 Participants |
Primary
Changes in Physical Examination Results. - Skin
Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system.
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HB-adMSCs | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Not Examined (No Longer In Study) | 5 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Normal | 35 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Abnormal | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Normal | 37 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Abnormal | 1 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 4 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Normal | 34 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Abnormal | 0 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 2 Participants |
| HB-adMSCs | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Not Examined (No Longer In Study) | 8 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Normal | 39 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Not Examined (No Longer In Study) | 5 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Abnormal | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Baseline/Infusion 1 (Week 0) | Not Examined (No Longer In Study) | 0 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Normal | 31 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Normal | 34 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Normal | 30 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Abnormal | 2 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 2 (Week 2) | Not Examined (No Longer In Study) | 4 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 4 (Week 10) | Abnormal | 1 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Normal | 34 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | End of Study (Week 26) | Not Examined (No Longer In Study) | 10 Participants |
| Placebo | Changes in Physical Examination Results. - Skin | Infusion 3 (Week 6) | Abnormal | 1 Participants |
Primary
Changes in Vital Signs. - Blood Pressure (mmHg)
Clinically significant changes in Blood Pressure.
Time frame: Baseline to Weeks 10, End of Study at Week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 4 (Week 10) | -3.1 mmHg | Standard Error 2.1 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 2 (Week 2) | -0.7 mmHg | Standard Error 1.82 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 3 (Week 6) | -0.6 mmHg | Standard Error 1.85 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic End of Study (Week 26) | -0.2 mmHg | Standard Error 1.74 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Baseline/Infusion 1 (Week 0) | 79.4 mmHg | Standard Error 1.32 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 2 (Week 2) | -0.9 mmHg | Standard Error 0.98 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 3 (Week 6) | -2.2 mmHg | Standard Error 1.48 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 4 (Week 10) | -0.8 mmHg | Standard Error 1.5 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic End of Study (Week 26) | 0.0 mmHg | Standard Error 1.32 |
| HB-adMSCs | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Basline/Infusion 1 (Week 0) | 122.2 mmHg | Standard Error 1.91 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 4 (Week 10) | -0.6 mmHg | Standard Error 1.46 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Basline/Infusion 1 (Week 0) | 125.2 mmHg | Standard Error 1.78 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 2 (Week 2) | -0.7 mmHg | Standard Error 0.92 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 2 (Week 2) | -1.8 mmHg | Standard Error 1.51 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 3 (Week 6) | 1.1 mmHg | Standard Error 1.57 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic Infusion 4 (Week 10) | -3.1 mmHg | Standard Error 1.52 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Infusion 3 (Week 6) | 0.1 mmHg | Standard Error 1.31 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Systolic End of Study (Week 26) | 0.3 mmHg | Standard Error 1.78 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic End of Study (Week 26) | 1.1 mmHg | Standard Error 1.39 |
| Placebo | Changes in Vital Signs. - Blood Pressure (mmHg) | Diastolic Baseline/Infusion 1 (Week 0) | 80.1 mmHg | Standard Error 1.06 |
Primary
Changes in Weight in kg.
Change from baseline in Weight in kg.
Time frame: Baseline to Weeks 10, End of Study at Week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Changes in Weight in kg. | Infusion 2 (Week 2) | -0.06 kg | Standard Error 0.342 |
| HB-adMSCs | Changes in Weight in kg. | Infusion 4 (Week 10) | 0.49 kg | Standard Error 0.645 |
| HB-adMSCs | Changes in Weight in kg. | Infusion 3 (Week 6) | 0.26 kg | Standard Error 0.476 |
| HB-adMSCs | Changes in Weight in kg. | End of Study (Week 26) | -0.30 kg | Standard Error 0.751 |
| HB-adMSCs | Changes in Weight in kg. | Baseline/ Infusion 1 (Week 0) | 79.35 kg | Standard Error 3.079 |
| Placebo | Changes in Weight in kg. | End of Study (Week 26) | 1.14 kg | Standard Error 0.925 |
| Placebo | Changes in Weight in kg. | Baseline/ Infusion 1 (Week 0) | 79.28 kg | Standard Error 2.403 |
| Placebo | Changes in Weight in kg. | Infusion 2 (Week 2) | 0.80 kg | Standard Error 0.551 |
| Placebo | Changes in Weight in kg. | Infusion 3 (Week 6) | 1.15 kg | Standard Error 0.602 |
| Placebo | Changes in Weight in kg. | Infusion 4 (Week 10) | 0.56 kg | Standard Error 0.627 |
Secondary
Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model)
Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model) | -8.094 score on a scale (50 points total) | Standard Error 1.442 |
| Placebo | Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model) | -6.660 score on a scale (50 points total) | Standard Error 1.538 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.505995% CI: [-5.72, 2.85]ANCOVA
Secondary
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches).
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model) | -0.893 score on a scale (10 points total) | Standard Error 0.446 |
| Placebo | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model) | -1.511 score on a scale (10 points total) | Standard Error 0.476 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.353595% CI: [-0.71, 1.94]ANCOVA
Secondary
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough).
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model) | -0.553 score on a scale (10 points total) | Standard Error 0.292 |
| Placebo | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model) | -0.248 score on a scale (10 points total) | Standard Error 0.312 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.484795% CI: [-1.18, 0.56]ANCOVA
Secondary
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea).
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model) | -1.354 score on a scale (10 points total) | Standard Error 0.275 |
| Placebo | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model) | -0.976 score on a scale (10 points total) | Standard Error 0.293 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.357795% CI: [-1.19, 0.44]ANCOVA
Secondary
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model) | -1.472 score on a scale (10 points total) | Standard Error 0.379 |
| Placebo | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model) | -1.269 score on a scale (10 points total) | Standard Error 0.405 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.719695% CI: [-1.33, 0.92]ANCOVA
Secondary
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain).
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model) | -1.319 score on a scale (10 points total) | Standard Error 0.44 |
| Placebo | Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model) | -1.790 score on a scale (10 points total) | Standard Error 0.47 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.474695% CI: [-0.84, 1.78]ANCOVA
Secondary
Changes in Subject's Level of Depression - PHQ 9 Scale.
Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) \[30\].
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes in Subject's Level of Depression - PHQ 9 Scale. | -3.666 score on a scale (27 points total) | Standard Error 0.938 |
| Placebo | Changes in Subject's Level of Depression - PHQ 9 Scale. | -3.545 score on a scale (27 points total) | Standard Error 1.001 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.873595% CI: [-2.91, 2.66]ANCOVA
Secondary
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health)
Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health) | 6.205 score on a scale (100 points total) | Standard Error 3.292 |
| Placebo | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health) | 12.301 score on a scale (100 points total) | Standard Error 3.52 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.226995% CI: [-16.08, 3.89]ANCOVA
Secondary
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score)
Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HB-adMSCs | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score) | 13.785 score on a scale (100 points total) | Standard Error 3.244 |
| Placebo | Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score) | 17.210 score on a scale (100 points total) | Standard Error 3.461 |
Comparison: The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.p-value: 0.480295% CI: [-13.07, 6.22]ANCOVA