COVID-19
Conditions
Keywords
Coronavirus, Prevention, Immune support, stem cells, mesenchymal stem cells, adipose-derived mesenchymal stem cells
Brief summary
Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
Detailed description
This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 51 patients were enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either 65 years of age or older, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary objective of this study is to provide immune support against COVID-19, measured by the presence or absence of adverse events and serious adverse events related to the study drug. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
Interventions
BIOLOGICALHB-adMSCs
Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26.
Sponsors
Hope Biosciences Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible. 1. Men, and women 65 years of age or older (according to CDC provisions) OR 2. Participant works in healthcare facility or other well characterized high-risk environment OR 3. Has underlying conditions including but not limited to cardiopathies, diabetes mellitus, cancer, COPD, asthma or any other systemic autoimmune disease. 4. Subject must have previously banked their cells at Hope Biosciences 5. No signs or symptoms of infection, including but not limited to, body temperature \>100 F and pulse rate \> 100 BPM. 6. Subject provides written informed consent prior to initiation of any study procedures. 7. Agrees to the collection of venous blood per protocol. 8. Agrees to conformational testing for SARS-CoV-2 before end of study.
Exclusion criteria
Subjects must not have any of the following criteria to be eligible. 1. Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures 2. Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days; 3. Inability to provide informed consent or to comply with test requirements; 4. Any medical disease or condition that, in the opinion of the site PI or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 5. Patients who have received a stem cell treatment within one year. 6. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study. 7. Patient currently or recently symptomatic for COVID-19 or anyone with COVID-19 associated symptoms within the past 30-days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hospitalization for COVID-19 | Week 0 through Week 26 (End of Study) | Number of subjects that require hospitalization for COVID-19 |
| Incidence of Symptoms for COVID-19 | Week 0 through Week 26 (End of Study) | Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Upper/Lower Respiratory Infection | Week 0 through Week 26 (End of Study) | Absence of upper/lower respiratory infection (with hospitalization criteria) |
| Change From Baseline in Glucose | Weeks 0, 6, 14, 26 | Change from baseline in level of glucose in the blood (mg/dL) |
| Change From Baseline in Calcium | Weeks 0, 6, 14, 26 | Change from baseline in level of calcium in the blood (mg/dL) |
| Change From Baseline in Albumin | Weeks 0, 6, 14, 26 | Change from baseline in level of albumin in the blood (g/dL) |
| Change From Baseline in Total Protein | Weeks 0, 6, 14, 26 | Change from baseline in level of total protein in the blood (g/dL) |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Sodium | Weeks 0, 6, 14, 26 | Change from baseline in level of sodium in the blood (mmol/L) |
| Change From Baseline in Total Carbon Dioxide | Weeks 0, 6, 14, 26 | Change from baseline in level of carbon dioxide in the blood (mmol/L) |
| Change From Baseline in Potassium | Weeks 0, 6, 14, 26 | Change from baseline in level of potassium in the blood (mmol/L) |
| Change From Baseline in Chloride | Weeks 0, 6, 14, 26 | Change from baseline in level of chloride in the blood (mmol/L) |
| Change From Baseline in Blood Urea Nitrogen (BUN) | Weeks 0, 6, 14, 26 | Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL) |
| Change From Baseline in Creatinine | Weeks 0, 6, 14, 26 | Change from baseline in level of creatinine in the blood (mg/dL) |
| Change From Baseline in Alkaline Phosphatase | Weeks 0, 6, 14, 26 | Change from baseline in level of alkaline phosphatase in the blood (IU/L) |
| Change From Baseline in Alanine Aminotransferase | Weeks 0, 6, 14, 26 | Change from baseline in level of alanine aminotransferase in the blood (IU/L) |
| Change From Baseline in Aspartate Aminotransferase | Weeks 0, 6, 14, 26 | Change from baseline in level of aspartate aminotransferase in the blood (IU/L) |
| Change From Baseline in Total Bilirubin | Weeks 0, 6, 14, 26 | Change from baseline in level of total bilirubin in the blood (mg/dL) |
| Change From Baseline in Leukocytes | Weeks 0, 6, 14, 26 | Change from baseline in level of leukocytes in the blood (x 10\^9/L) |
| Change From Baseline in Erythrocytes | Weeks 0, 6, 14, 26 | Change from baseline in erythrocytes in the blood (10\^12/L) |
| Change From Baseline in Hemoglobin | Weeks 0, 6, 14, 26 | Change from baseline in level of hemoglobin in the blood (g/dL) |
| Change From Baseline in Hematocrit | Weeks 0, 6, 14, 26 | Change from baseline in level of hematocrit in the blood (%) |
| Change From Baseline in Mean Corpuscular Volume | Weeks 0, 6, 14, 26 | Change from baseline in mean corpuscular volume in the blood (fL) |
| Change From Baseline in Mean Corpuscular Hemoglobin | Weeks 0, 6, 14, 26 | Change from baseline in mean corpuscular hemoglobin in the blood (pg) |
| Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Weeks 0, 6, 14, 26 | Change from baseline in mean corpuscular hemoglobin in the blood (g/dL) |
| Change From Baseline in Erythrocyte Distribution Width | Weeks 0, 6, 14, 26 | Change from baseline in erythrocyte distribution width in the blood (%) |
| Change From Baseline in Neutrophils | Weeks 0, 6, 14, 26 | Change from baseline in neutrophils in the blood (%) (leukocyte differential) |
| Change From Baseline in Lymphocytes | Weeks 0, 6, 14, 26 | Change from baseline in lymphocytes in the blood (%) (leukocyte differential) |
| Change From Baseline in Monocytes | Weeks 0, 6, 14, 26 | Change from baseline in monocytes in the blood (%) (leukocyte differential) |
| Change From Baseline in Eosinophils | Weeks 0, 6, 14, 26 | Change from baseline in eosinophils in the blood (%) (leukocyte differential) |
| Change From Baseline in Basophils | Weeks 0, 6, 14, 26 | Change from baseline in basophils in the blood (%) (leukocyte differential) |
| Change From Baseline in Platelets | Weeks 0, 6, 14, 26 | Change from baseline in platelets in the blood (x 10\^9/L) |
| Change From Baseline in Prothrombin Time | Weeks 0, 6, 14, 26 | Change from baseline in prothrombin time in the blood (seconds) |
| Change From Baseline in International Normalized Ratio (INR) | Weeks 0, 6, 14, 26 | Change from baseline in international normalized ratio in the blood (INR) (ratio) |
| Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Weeks 0, 6, 14, 26 | Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L) |
| Change From Baseline in Interleukin-6 | Weeks 0, 6, 14, 26 | Change from baseline in Interleukin-6 in the blood (ng/L) |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Interleukin-10 | Weeks 0, 6, 14, 26 | Change from baseline in Interleukin-10 in the blood (ng/L) |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Weeks 0, 2, 6, 10, 14, 18, 22, 26 | Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability. |
| Change From Baseline in C-Reactive Protein | Weeks 0, 6, 14, 26 | Change from baseline in C-Reactive Protein in the blood (mg/dL) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HB-adMSCs Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26.
HB-adMSCs: Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | HB-adMSCs |
|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 18.36 |
| Age, Customized 18-60 years | 30 Participants |
| Age, Customized 61-80 years | 18 Participants |
| Age, Customized > 80 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 167.59 centimeters STANDARD_DEVIATION 9.642 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 22 Participants |
| Weight | 73.05 kilograms STANDARD_DEVIATION 17.086 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 42 / 51 |
| serious Total, serious adverse events | 3 / 51 |
Outcome results
Primary
Incidence of Hospitalization for COVID-19
Number of subjects that require hospitalization for COVID-19
Time frame: Week 0 through Week 26 (End of Study)
Population: There was no incidence of hospitalization for COVID-19 in this study. Therefore, the analyses for this outcome measure were not performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HB-adMSCs | Incidence of Hospitalization for COVID-19 | 0 Participants |
Primary
Incidence of Symptoms for COVID-19
Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough
Time frame: Week 0 through Week 26 (End of Study)
Population: There was no incidence of symptoms for COVID-19 in this study. Therefore, the analyses for this outcome measure were not performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HB-adMSCs | Incidence of Symptoms for COVID-19 | 0 Participants |
Secondary
Absence of Upper/Lower Respiratory Infection
Absence of upper/lower respiratory infection (with hospitalization criteria)
Time frame: Week 0 through Week 26 (End of Study)
Population: There was no upper/lower respiratory infection due to COVID-19 reported in this study. Therefore, the analyses for this outcome measure were not performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HB-adMSCs | Absence of Upper/Lower Respiratory Infection | 0 Participants |
Secondary
Change From Baseline in Alanine Aminotransferase
Change from baseline in level of alanine aminotransferase in the blood (IU/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Alanine Aminotransferase | Week 0 | 21.2 IU/L | Standard Deviation 8.87 |
| HB-adMSCs | Change From Baseline in Alanine Aminotransferase | Week 6 | -2.0 IU/L | Standard Deviation 4.95 |
| HB-adMSCs | Change From Baseline in Alanine Aminotransferase | Week 14 | -3.2 IU/L | Standard Deviation 5.55 |
| HB-adMSCs | Change From Baseline in Alanine Aminotransferase | Week 26 | -1.1 IU/L | Standard Deviation 6.82 |
Secondary
Change From Baseline in Albumin
Change from baseline in level of albumin in the blood (g/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Albumin | Week 0 | 4.62 g/dL | Standard Deviation 0.306 |
| HB-adMSCs | Change From Baseline in Albumin | Week 6 | -0.10 g/dL | Standard Deviation 0.28 |
| HB-adMSCs | Change From Baseline in Albumin | Week 14 | -0.22 g/dL | Standard Deviation 0.301 |
| HB-adMSCs | Change From Baseline in Albumin | Week 26 | -0.05 g/dL | Standard Deviation 0.283 |
Secondary
Change From Baseline in Alkaline Phosphatase
Change from baseline in level of alkaline phosphatase in the blood (IU/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Alkaline Phosphatase | Week 0 | 61.9 IU/L | Standard Deviation 20.56 |
| HB-adMSCs | Change From Baseline in Alkaline Phosphatase | Week 6 | -1.0 IU/L | Standard Deviation 6.69 |
| HB-adMSCs | Change From Baseline in Alkaline Phosphatase | Week 14 | -2.3 IU/L | Standard Deviation 6.5 |
| HB-adMSCs | Change From Baseline in Alkaline Phosphatase | Week 26 | 5.3 IU/L | Standard Deviation 9.59 |
Secondary
Change From Baseline in Aspartate Aminotransferase
Change from baseline in level of aspartate aminotransferase in the blood (IU/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Aspartate Aminotransferase | Week 0 | 22.7 IU/L | Standard Deviation 6.77 |
| HB-adMSCs | Change From Baseline in Aspartate Aminotransferase | Week 6 | -3.3 IU/L | Standard Deviation 6.37 |
| HB-adMSCs | Change From Baseline in Aspartate Aminotransferase | Week 14 | -3.1 IU/L | Standard Deviation 6.26 |
| HB-adMSCs | Change From Baseline in Aspartate Aminotransferase | Week 26 | -0.1 IU/L | Standard Deviation 6.03 |
Secondary
Change From Baseline in Basophils
Change from baseline in basophils in the blood (%) (leukocyte differential)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Basophils | Week 0 | 0.6 percentage of basophils in the blood | Standard Deviation 0.55 |
| HB-adMSCs | Change From Baseline in Basophils | Week 6 | 0.18 percentage of basophils in the blood | Standard Deviation 0.54 |
| HB-adMSCs | Change From Baseline in Basophils | Week 14 | 0.29 percentage of basophils in the blood | Standard Deviation 0.457 |
| HB-adMSCs | Change From Baseline in Basophils | Week 26 | 0.25 percentage of basophils in the blood | Standard Deviation 0.439 |
Secondary
Change From Baseline in Blood Urea Nitrogen (BUN)
Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Blood Urea Nitrogen (BUN) | Week 0 | 15.0 mg/dL | Standard Deviation 4.21 |
| HB-adMSCs | Change From Baseline in Blood Urea Nitrogen (BUN) | Week 6 | -1.0 mg/dL | Standard Deviation 3.22 |
| HB-adMSCs | Change From Baseline in Blood Urea Nitrogen (BUN) | Week 14 | 0.5 mg/dL | Standard Deviation 3.67 |
| HB-adMSCs | Change From Baseline in Blood Urea Nitrogen (BUN) | Week 26 | -0.7 mg/dL | Standard Deviation 3.61 |
Secondary
Change From Baseline in Calcium
Change from baseline in level of calcium in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Calcium | Week 0 | 9.44 mg/dL | Standard Deviation 0.41 |
| HB-adMSCs | Change From Baseline in Calcium | Week 6 | -0.03 mg/dL | Standard Deviation 0.455 |
| HB-adMSCs | Change From Baseline in Calcium | Week 14 | 0.00 mg/dL | Standard Deviation 0.441 |
| HB-adMSCs | Change From Baseline in Calcium | Week 26 | -0.03 mg/dL | Standard Deviation 0.394 |
Secondary
Change From Baseline in Chloride
Change from baseline in level of chloride in the blood (mmol/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Chloride | Week 0 | 102.0 mmol/L | Standard Deviation 2.73 |
| HB-adMSCs | Change From Baseline in Chloride | Week 6 | -0.7 mmol/L | Standard Deviation 2.82 |
| HB-adMSCs | Change From Baseline in Chloride | Week 14 | 0.1 mmol/L | Standard Deviation 2.39 |
| HB-adMSCs | Change From Baseline in Chloride | Week 26 | -0.4 mmol/L | Standard Deviation 2.37 |
Secondary
Change From Baseline in C-Reactive Protein
Change from baseline in C-Reactive Protein in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 24. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in C-Reactive Protein | Week 0 | 5.0 mg/dL | Standard Deviation 6.69 |
| HB-adMSCs | Change From Baseline in C-Reactive Protein | Week 6 | -0.26 mg/dL | Standard Deviation 1.759 |
| HB-adMSCs | Change From Baseline in C-Reactive Protein | Week 14 | -0.35 mg/dL | Standard Deviation 2.422 |
| HB-adMSCs | Change From Baseline in C-Reactive Protein | Week 26 | -0.43 mg/dL | Standard Deviation 1.342 |
Secondary
Change From Baseline in Creatinine
Change from baseline in level of creatinine in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Creatinine | Week 0 | 0.838 mg/dL | Standard Deviation 0.1946 |
| HB-adMSCs | Change From Baseline in Creatinine | Week 6 | -0.003 mg/dL | Standard Deviation 0.1007 |
| HB-adMSCs | Change From Baseline in Creatinine | Week 14 | -0.000 mg/dL | Standard Deviation 0.1383 |
| HB-adMSCs | Change From Baseline in Creatinine | Week 26 | -0.013 mg/dL | Standard Deviation 0.0895 |
Secondary
Change From Baseline in Eosinophils
Change from baseline in eosinophils in the blood (%) (leukocyte differential)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Eosinophils | Week 0 | 2.3 percentage of eosinophils in the blood | Standard Deviation 2.14 |
| HB-adMSCs | Change From Baseline in Eosinophils | Week 6 | 0.23 percentage of eosinophils in the blood | Standard Deviation 1.118 |
| HB-adMSCs | Change From Baseline in Eosinophils | Week 14 | -0.02 percentage of eosinophils in the blood | Standard Deviation 1.44 |
| HB-adMSCs | Change From Baseline in Eosinophils | Week 26 | -0.03 percentage of eosinophils in the blood | Standard Deviation 1.577 |
Secondary
Change From Baseline in Erythrocyte Distribution Width
Change from baseline in erythrocyte distribution width in the blood (%)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Erythrocyte Distribution Width | Week 0 | 14.00 % of erythrocytes | Standard Deviation 1.739 |
| HB-adMSCs | Change From Baseline in Erythrocyte Distribution Width | Week 6 | -1.09 % of erythrocytes | Standard Deviation 1.628 |
| HB-adMSCs | Change From Baseline in Erythrocyte Distribution Width | Week 14 | -1.14 % of erythrocytes | Standard Deviation 0.965 |
| HB-adMSCs | Change From Baseline in Erythrocyte Distribution Width | Week 26 | -1.00 % of erythrocytes | Standard Deviation 0.804 |
Secondary
Change From Baseline in Erythrocytes
Change from baseline in erythrocytes in the blood (10\^12/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Erythrocytes | Week 0 | 4.610 10^12 cells/L | Standard Deviation 0.5315 |
| HB-adMSCs | Change From Baseline in Erythrocytes | Week 6 | 0.018 10^12 cells/L | Standard Deviation 0.2687 |
| HB-adMSCs | Change From Baseline in Erythrocytes | Week 14 | -0.015 10^12 cells/L | Standard Deviation 0.2871 |
| HB-adMSCs | Change From Baseline in Erythrocytes | Week 26 | 0.042 10^12 cells/L | Standard Deviation 0.234 |
Secondary
Change From Baseline in Glucose
Change from baseline in level of glucose in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 50. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Glucose | Week 0 | 96.4 mg/dL | Standard Deviation 16.11 |
| HB-adMSCs | Change From Baseline in Glucose | Week 6 | -4.1 mg/dL | Standard Deviation 18 |
| HB-adMSCs | Change From Baseline in Glucose | Week 14 | 5.8 mg/dL | Standard Deviation 21.07 |
| HB-adMSCs | Change From Baseline in Glucose | Week 26 | 6.8 mg/dL | Standard Deviation 40.9 |
Secondary
Change From Baseline in Hematocrit
Change from baseline in level of hematocrit in the blood (%)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Hematocrit | Week 0 | 43.27 percentage of erythrocytes | Standard Deviation 4.636 |
| HB-adMSCs | Change From Baseline in Hematocrit | Week 6 | -0.70 percentage of erythrocytes | Standard Deviation 2.757 |
| HB-adMSCs | Change From Baseline in Hematocrit | Week 14 | -1.60 percentage of erythrocytes | Standard Deviation 2.991 |
| HB-adMSCs | Change From Baseline in Hematocrit | Week 26 | -1.06 percentage of erythrocytes | Standard Deviation 2.737 |
Secondary
Change From Baseline in Hemoglobin
Change from baseline in level of hemoglobin in the blood (g/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Hemoglobin | Week 0 | 13.83 g/dL | Standard Deviation 1.702 |
| HB-adMSCs | Change From Baseline in Hemoglobin | Week 6 | -0.02 g/dL | Standard Deviation 0.789 |
| HB-adMSCs | Change From Baseline in Hemoglobin | Week 14 | -0.22 g/dL | Standard Deviation 0.931 |
| HB-adMSCs | Change From Baseline in Hemoglobin | Week 26 | 0.03 g/dL | Standard Deviation 0.814 |
Secondary
Change From Baseline in Interleukin-10
Change from baseline in Interleukin-10 in the blood (ng/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 27. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Interleukin-10 | Week 14 | 0.83 ng/L | Standard Deviation 3.074 |
| HB-adMSCs | Change From Baseline in Interleukin-10 | Week 0 | 6.1 ng/L | Standard Deviation 2.62 |
| HB-adMSCs | Change From Baseline in Interleukin-10 | Week 6 | 1.63 ng/L | Standard Deviation 2.483 |
| HB-adMSCs | Change From Baseline in Interleukin-10 | Week 26 | 7.99 ng/L | Standard Deviation 21.579 |
Secondary
Change From Baseline in Interleukin-6
Change from baseline in Interleukin-6 in the blood (ng/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 33. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Interleukin-6 | Week 0 | 2.5 ng/L | Standard Deviation 2.07 |
| HB-adMSCs | Change From Baseline in Interleukin-6 | Week 6 | 0.78 ng/L | Standard Deviation 3.071 |
| HB-adMSCs | Change From Baseline in Interleukin-6 | Week 14 | 0.59 ng/L | Standard Deviation 2.938 |
| HB-adMSCs | Change From Baseline in Interleukin-6 | Week 26 | -0.50 ng/L | Standard Deviation 2.344 |
Secondary
Change From Baseline in International Normalized Ratio (INR)
Change from baseline in international normalized ratio in the blood (INR) (ratio)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in International Normalized Ratio (INR) | Week 0 | 1.06 ratio | Standard Deviation 0.077 |
| HB-adMSCs | Change From Baseline in International Normalized Ratio (INR) | Week 6 | -0.01 ratio | Standard Deviation 0.074 |
| HB-adMSCs | Change From Baseline in International Normalized Ratio (INR) | Week 14 | 0.03 ratio | Standard Deviation 0.078 |
| HB-adMSCs | Change From Baseline in International Normalized Ratio (INR) | Week 26 | 0.08 ratio | Standard Deviation 0.093 |
Secondary
Change From Baseline in Leukocytes
Change from baseline in level of leukocytes in the blood (x 10\^9/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Leukocytes | Week 0 | 6.41 10^9 cells/L | Standard Deviation 1.888 |
| HB-adMSCs | Change From Baseline in Leukocytes | Week 6 | -0.13 10^9 cells/L | Standard Deviation 1.397 |
| HB-adMSCs | Change From Baseline in Leukocytes | Week 14 | 0.07 10^9 cells/L | Standard Deviation 1.248 |
| HB-adMSCs | Change From Baseline in Leukocytes | Week 26 | 0.01 10^9 cells/L | Standard Deviation 1.553 |
Secondary
Change From Baseline in Lymphocytes
Change from baseline in lymphocytes in the blood (%) (leukocyte differential)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Lymphocytes | Week 0 | 30.5 percentage of lymphocytes in the blood | Standard Deviation 8.15 |
| HB-adMSCs | Change From Baseline in Lymphocytes | Week 6 | 0.27 percentage of lymphocytes in the blood | Standard Deviation 7.049 |
| HB-adMSCs | Change From Baseline in Lymphocytes | Week 14 | -0.19 percentage of lymphocytes in the blood | Standard Deviation 7.487 |
| HB-adMSCs | Change From Baseline in Lymphocytes | Week 26 | 0.63 percentage of lymphocytes in the blood | Standard Deviation 7.413 |
Secondary
Change From Baseline in Mean Corpuscular Hemoglobin
Change from baseline in mean corpuscular hemoglobin in the blood (pg)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin | Week 0 | 30.05 pg | Standard Deviation 2.119 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin | Week 6 | -0.15 pg | Standard Deviation 0.697 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin | Week 14 | -0.33 pg | Standard Deviation 0.53 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin | Week 26 | -0.17 pg | Standard Deviation 1.004 |
Secondary
Change From Baseline in Mean Corpuscular Hemoglobin Concentration
Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Week 0 | 31.94 g/dL | Standard Deviation 1.401 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Week 6 | 0.47 g/dL | Standard Deviation 1.097 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Week 14 | 0.70 g/dL | Standard Deviation 1.476 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Week 26 | 0.88 g/dL | Standard Deviation 1.292 |
Secondary
Change From Baseline in Mean Corpuscular Volume
Change from baseline in mean corpuscular volume in the blood (fL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Mean Corpuscular Volume | Week 0 | 94.2 fL | Standard Deviation 6.35 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Volume | Week 6 | -2.0 fL | Standard Deviation 2.81 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Volume | Week 14 | -3.1 fL | Standard Deviation 3.86 |
| HB-adMSCs | Change From Baseline in Mean Corpuscular Volume | Week 26 | -3.2 fL | Standard Deviation 3.82 |
Secondary
Change From Baseline in Monocytes
Change from baseline in monocytes in the blood (%) (leukocyte differential)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Monocytes | Week 0 | 7.3 percentage of monocytes in the blood | Standard Deviation 1.85 |
| HB-adMSCs | Change From Baseline in Monocytes | Week 6 | 0.05 percentage of monocytes in the blood | Standard Deviation 1.765 |
| HB-adMSCs | Change From Baseline in Monocytes | Week 14 | 0.29 percentage of monocytes in the blood | Standard Deviation 1.384 |
| HB-adMSCs | Change From Baseline in Monocytes | Week 26 | 0.03 percentage of monocytes in the blood | Standard Deviation 1.387 |
Secondary
Change From Baseline in Neutrophils
Change from baseline in neutrophils in the blood (%) (leukocyte differential)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Neutrophils | Week 0 | 59.2 percentage of neutrophils in the blood | Standard Deviation 8.62 |
| HB-adMSCs | Change From Baseline in Neutrophils | Week 6 | -0.70 percentage of neutrophils in the blood | Standard Deviation 8.123 |
| HB-adMSCs | Change From Baseline in Neutrophils | Week 14 | -0.40 percentage of neutrophils in the blood | Standard Deviation 8.121 |
| HB-adMSCs | Change From Baseline in Neutrophils | Week 26 | -1.10 percentage of neutrophils in the blood | Standard Deviation 8.111 |
Secondary
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score
Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 0 | 4.9 score on a scale | Standard Deviation 6.43 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 2 | -1.67 score on a scale | Standard Deviation 5.981 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 6 | -1.24 score on a scale | Standard Deviation 5.832 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 10 | -2.30 score on a scale | Standard Deviation 6.081 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 14 | -1.81 score on a scale | Standard Deviation 7.433 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 18 | -2.68 score on a scale | Standard Deviation 5.803 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 22 | -2.05 score on a scale | Standard Deviation 4.19 |
| HB-adMSCs | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Week 26 | -1.95 score on a scale | Standard Deviation 6.569 |
Secondary
Change From Baseline in Platelets
Change from baseline in platelets in the blood (x 10\^9/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Platelets | Week 0 | 268.8 10^9 cells/L | Standard Deviation 73.48 |
| HB-adMSCs | Change From Baseline in Platelets | Week 6 | -0.3 10^9 cells/L | Standard Deviation 30.85 |
| HB-adMSCs | Change From Baseline in Platelets | Week 14 | -1.9 10^9 cells/L | Standard Deviation 29.5 |
| HB-adMSCs | Change From Baseline in Platelets | Week 26 | -11.6 10^9 cells/L | Standard Deviation 26.06 |
Secondary
Change From Baseline in Potassium
Change from baseline in level of potassium in the blood (mmol/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Potassium | Week 0 | 4.31 mmol/L | Standard Deviation 0.364 |
| HB-adMSCs | Change From Baseline in Potassium | Week 6 | -0.21 mmol/L | Standard Deviation 0.409 |
| HB-adMSCs | Change From Baseline in Potassium | Week 14 | -0.16 mmol/L | Standard Deviation 0.369 |
| HB-adMSCs | Change From Baseline in Potassium | Week 26 | -0.10 mmol/L | Standard Deviation 0.415 |
Secondary
Change From Baseline in Prothrombin Time
Change from baseline in prothrombin time in the blood (seconds)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Prothrombin Time | Week 0 | 11.16 seconds | Standard Deviation 0.663 |
| HB-adMSCs | Change From Baseline in Prothrombin Time | Week 6 | -0.08 seconds | Standard Deviation 0.596 |
| HB-adMSCs | Change From Baseline in Prothrombin Time | Week 14 | 0.20 seconds | Standard Deviation 0.647 |
| HB-adMSCs | Change From Baseline in Prothrombin Time | Week 26 | 0.49 seconds | Standard Deviation 0.766 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being
Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 0 | 76.4 score on a scale | Standard Deviation 16.43 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 2 | 2.93 score on a scale | Standard Deviation 14.204 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 6 | 2.84 score on a scale | Standard Deviation 12.435 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 10 | 6.60 score on a scale | Standard Deviation 15.116 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 14 | 7.07 score on a scale | Standard Deviation 14.757 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 18 | 6.24 score on a scale | Standard Deviation 17.483 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 22 | 5.08 score on a scale | Standard Deviation 13.12 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Week 26 | 7.12 score on a scale | Standard Deviation 13.342 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue
Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 0 | 59.7 score on a scale | Standard Deviation 26.34 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 2 | 5.44 score on a scale | Standard Deviation 19.564 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 6 | 5.89 score on a scale | Standard Deviation 16.036 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 10 | 9.07 score on a scale | Standard Deviation 18.266 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 14 | 10.93 score on a scale | Standard Deviation 21.22 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 18 | 11.59 score on a scale | Standard Deviation 22.54 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 22 | 9.46 score on a scale | Standard Deviation 18.135 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Week 26 | 9.51 score on a scale | Standard Deviation 21.148 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average 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: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 0 | 68.2 score on a scale | Standard Deviation 27.31 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 2 | 2.44 score on a scale | Standard Deviation 15.211 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 6 | 5.00 score on a scale | Standard Deviation 17.023 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 10 | 6.16 score on a scale | Standard Deviation 16.36 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 14 | 8.26 score on a scale | Standard Deviation 18.577 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 18 | 8.05 score on a scale | Standard Deviation 19.839 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 22 | 6.22 score on a scale | Standard Deviation 16.558 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Week 26 | 7.80 score on a scale | Standard Deviation 20.002 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain
Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 0 | 74.4 score on a scale | Standard Deviation 27.94 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 2 | 6.17 score on a scale | Standard Deviation 23.089 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 6 | 6.33 score on a scale | Standard Deviation 22.295 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 10 | 9.42 score on a scale | Standard Deviation 22.729 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 14 | 11.57 score on a scale | Standard Deviation 19.327 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 18 | 9.57 score on a scale | Standard Deviation 16.639 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 22 | 5.07 score on a scale | Standard Deviation 19.225 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Week 26 | 7.80 score on a scale | Standard Deviation 18.176 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning
Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 0 | 78.8 score on a scale | Standard Deviation 27.92 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 2 | 0.67 score on a scale | Standard Deviation 16.011 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 6 | 2.89 score on a scale | Standard Deviation 15.576 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 10 | 2.09 score on a scale | Standard Deviation 16.229 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 14 | 5.70 score on a scale | Standard Deviation 16.278 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 18 | 4.76 score on a scale | Standard Deviation 17.028 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 22 | 4.05 score on a scale | Standard Deviation 15.449 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Week 26 | 4.76 score on a scale | Standard Deviation 16.694 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems
Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 0 | 76.3 score on a scale | Standard Deviation 40.59 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 2 | 7.41 score on a scale | Standard Deviation 28.328 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 6 | 9.63 score on a scale | Standard Deviation 35.264 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 10 | 12.40 score on a scale | Standard Deviation 36.387 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 14 | 10.85 score on a scale | Standard Deviation 36.89 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 18 | 11.38 score on a scale | Standard Deviation 42.564 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 22 | 8.11 score on a scale | Standard Deviation 38.814 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Week 26 | 8.13 score on a scale | Standard Deviation 36.347 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health
Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 0 | 72.8 score on a scale | Standard Deviation 40.18 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 2 | 0.56 score on a scale | Standard Deviation 34.332 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 6 | 11.11 score on a scale | Standard Deviation 31.782 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 10 | 8.72 score on a scale | Standard Deviation 36.954 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 14 | 12.21 score on a scale | Standard Deviation 36.34 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 18 | 10.98 score on a scale | Standard Deviation 35.816 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 22 | 12.16 score on a scale | Standard Deviation 33.136 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Week 26 | 9.15 score on a scale | Standard Deviation 33.427 |
Secondary
Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning
Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.
Time frame: Weeks 0, 2, 6, 10, 14, 18, 22, 26
Population: At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 0 | 83.1 score on a scale | Standard Deviation 24.01 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 2 | 4.72 score on a scale | Standard Deviation 17.935 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 6 | 0.83 score on a scale | Standard Deviation 22.519 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 10 | 7.85 score on a scale | Standard Deviation 21.826 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 14 | 5.81 score on a scale | Standard Deviation 19.736 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 18 | 8.54 score on a scale | Standard Deviation 22.611 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 22 | 4.73 score on a scale | Standard Deviation 16.497 |
| HB-adMSCs | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Week 26 | 5.18 score on a scale | Standard Deviation 19.759 |
Secondary
Change From Baseline in Sodium
Change from baseline in level of sodium in the blood (mmol/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Sodium | Week 0 | 141.0 mmol/L | Standard Deviation 2.11 |
| HB-adMSCs | Change From Baseline in Sodium | Week 6 | -0.7 mmol/L | Standard Deviation 2.53 |
| HB-adMSCs | Change From Baseline in Sodium | Week 14 | -1.3 mmol/L | Standard Deviation 2.17 |
| HB-adMSCs | Change From Baseline in Sodium | Week 26 | -1.4 mmol/L | Standard Deviation 2.29 |
Secondary
Change From Baseline in Total Bilirubin
Change from baseline in level of total bilirubin in the blood (mg/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Total Bilirubin | Week 0 | 0.50 mg/dL | Standard Deviation 0.338 |
| HB-adMSCs | Change From Baseline in Total Bilirubin | Week 6 | -0.03 mg/dL | Standard Deviation 0.185 |
| HB-adMSCs | Change From Baseline in Total Bilirubin | Week 14 | -0.03 mg/dL | Standard Deviation 0.212 |
| HB-adMSCs | Change From Baseline in Total Bilirubin | Week 26 | -0.05 mg/dL | Standard Deviation 0.195 |
Secondary
Change From Baseline in Total Carbon Dioxide
Change from baseline in level of carbon dioxide in the blood (mmol/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Total Carbon Dioxide | Week 0 | 23.4 mmol/L | Standard Deviation 2.8 |
| HB-adMSCs | Change From Baseline in Total Carbon Dioxide | Week 6 | 0.9 mmol/L | Standard Deviation 2.76 |
| HB-adMSCs | Change From Baseline in Total Carbon Dioxide | Week 14 | 0.6 mmol/L | Standard Deviation 2.68 |
| HB-adMSCs | Change From Baseline in Total Carbon Dioxide | Week 26 | 0.1 mmol/L | Standard Deviation 2.92 |
Secondary
Change From Baseline in Total Protein
Change from baseline in level of total protein in the blood (g/dL)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Total Protein | Week 0 | 6.89 g/dL | Standard Deviation 0.469 |
| HB-adMSCs | Change From Baseline in Total Protein | Week 6 | -0.04 g/dL | Standard Deviation 0.394 |
| HB-adMSCs | Change From Baseline in Total Protein | Week 14 | -0.11 g/dL | Standard Deviation 0.5 |
| HB-adMSCs | Change From Baseline in Total Protein | Week 26 | 0.02 g/dL | Standard Deviation 0.428 |
Secondary
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha)
Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)
Time frame: Weeks 0, 6, 14, 26
Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Week 0 | 1.75 ng/L | Standard Deviation 4.974 |
| HB-adMSCs | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Week 6 | 0.02 ng/L | Standard Deviation 0.902 |
| HB-adMSCs | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Week 14 | -0.12 ng/L | Standard Deviation 0.759 |
| HB-adMSCs | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Week 26 | -0.26 ng/L | Standard Deviation 1.271 |