Trial Outcomes & Findings for A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19 (NCT NCT04349631)

NCT ID: NCT04349631

Last Updated: 2025-09-26

Results Overview

Number of subjects that require hospitalization for COVID-19

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Week 0 through Week 26 (End of Study)
• Results posted on: 2025-09-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	7

Baseline Characteristics

A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19

Baseline characteristics by cohort

Measure	HB-adMSCs n=51 Participants 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.
Age, Continuous	54.2 years STANDARD_DEVIATION 18.36 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Customized 18-60 years	30 Participants n=5 Participants
Age, Customized 61-80 years	18 Participants n=5 Participants
Age, Customized > 80 years	3 Participants n=5 Participants
Height	167.59 centimeters STANDARD_DEVIATION 9.642 • n=5 Participants
Weight	73.05 kilograms STANDARD_DEVIATION 17.086 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Number of subjects that require hospitalization for COVID-19

Outcome measures

Measure

HB-adMSCs n=51 Participants 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.

Incidence of Hospitalization for COVID-19

0 Participants

PRIMARY outcome

Timeframe: 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.

Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough

Outcome measures

Measure

HB-adMSCs n=51 Participants 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.

Incidence of Symptoms for COVID-19

0 Participants

SECONDARY outcome

Timeframe: 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.

Absence of upper/lower respiratory infection (with hospitalization criteria)

Outcome measures

Measure

HB-adMSCs n=51 Participants 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.

Absence of Upper/Lower Respiratory Infection

0 Participants

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 50. This was the largest N collected.

Change from baseline in level of glucose in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=50 Participants 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.
Change From Baseline in Glucose Week 0	96.4 mg/dL Standard Deviation 16.11
Change From Baseline in Glucose Week 6	-4.1 mg/dL Standard Deviation 18.00
Change From Baseline in Glucose Week 14	5.8 mg/dL Standard Deviation 21.07
Change From Baseline in Glucose Week 26	6.8 mg/dL Standard Deviation 40.90

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of calcium in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Calcium Week 0	9.44 mg/dL Standard Deviation 0.410
Change From Baseline in Calcium Week 6	-0.03 mg/dL Standard Deviation 0.455
Change From Baseline in Calcium Week 14	0.00 mg/dL Standard Deviation 0.441
Change From Baseline in Calcium Week 26	-0.03 mg/dL Standard Deviation 0.394

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of albumin in the blood (g/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Albumin Week 0	4.62 g/dL Standard Deviation 0.306
Change From Baseline in Albumin Week 6	-0.10 g/dL Standard Deviation 0.280
Change From Baseline in Albumin Week 14	-0.22 g/dL Standard Deviation 0.301
Change From Baseline in Albumin Week 26	-0.05 g/dL Standard Deviation 0.283

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of total protein in the blood (g/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Total Protein Week 0	6.89 g/dL Standard Deviation 0.469
Change From Baseline in Total Protein Week 6	-0.04 g/dL Standard Deviation 0.394
Change From Baseline in Total Protein Week 14	-0.11 g/dL Standard Deviation 0.500
Change From Baseline in Total Protein Week 26	0.02 g/dL Standard Deviation 0.428

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of sodium in the blood (mmol/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Sodium Week 0	141.0 mmol/L Standard Deviation 2.11
Change From Baseline in Sodium Week 6	-0.7 mmol/L Standard Deviation 2.53
Change From Baseline in Sodium Week 14	-1.3 mmol/L Standard Deviation 2.17
Change From Baseline in Sodium Week 26	-1.4 mmol/L Standard Deviation 2.29

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of carbon dioxide in the blood (mmol/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Total Carbon Dioxide Week 0	23.4 mmol/L Standard Deviation 2.80
Change From Baseline in Total Carbon Dioxide Week 6	0.9 mmol/L Standard Deviation 2.76
Change From Baseline in Total Carbon Dioxide Week 14	0.6 mmol/L Standard Deviation 2.68
Change From Baseline in Total Carbon Dioxide Week 26	0.1 mmol/L Standard Deviation 2.92

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of potassium in the blood (mmol/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Potassium Week 0	4.31 mmol/L Standard Deviation 0.364
Change From Baseline in Potassium Week 6	-0.21 mmol/L Standard Deviation 0.409
Change From Baseline in Potassium Week 14	-0.16 mmol/L Standard Deviation 0.369
Change From Baseline in Potassium Week 26	-0.10 mmol/L Standard Deviation 0.415

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of chloride in the blood (mmol/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Chloride Week 0	102.0 mmol/L Standard Deviation 2.73
Change From Baseline in Chloride Week 6	-0.7 mmol/L Standard Deviation 2.82
Change From Baseline in Chloride Week 14	0.1 mmol/L Standard Deviation 2.39
Change From Baseline in Chloride Week 26	-0.4 mmol/L Standard Deviation 2.37

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Blood Urea Nitrogen (BUN) Week 0	15.0 mg/dL Standard Deviation 4.21
Change From Baseline in Blood Urea Nitrogen (BUN) Week 6	-1.0 mg/dL Standard Deviation 3.22
Change From Baseline in Blood Urea Nitrogen (BUN) Week 14	0.5 mg/dL Standard Deviation 3.67
Change From Baseline in Blood Urea Nitrogen (BUN) Week 26	-0.7 mg/dL Standard Deviation 3.61

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of creatinine in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Creatinine Week 0	0.838 mg/dL Standard Deviation 0.1946
Change From Baseline in Creatinine Week 6	-0.003 mg/dL Standard Deviation 0.1007
Change From Baseline in Creatinine Week 14	-0.000 mg/dL Standard Deviation 0.1383
Change From Baseline in Creatinine Week 26	-0.013 mg/dL Standard Deviation 0.0895

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of alkaline phosphatase in the blood (IU/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Alkaline Phosphatase Week 0	61.9 IU/L Standard Deviation 20.56
Change From Baseline in Alkaline Phosphatase Week 6	-1.0 IU/L Standard Deviation 6.69
Change From Baseline in Alkaline Phosphatase Week 14	-2.3 IU/L Standard Deviation 6.50
Change From Baseline in Alkaline Phosphatase Week 26	5.3 IU/L Standard Deviation 9.59

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of alanine aminotransferase in the blood (IU/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Alanine Aminotransferase Week 0	21.2 IU/L Standard Deviation 8.87
Change From Baseline in Alanine Aminotransferase Week 6	-2.0 IU/L Standard Deviation 4.95
Change From Baseline in Alanine Aminotransferase Week 14	-3.2 IU/L Standard Deviation 5.55
Change From Baseline in Alanine Aminotransferase Week 26	-1.1 IU/L Standard Deviation 6.82

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of aspartate aminotransferase in the blood (IU/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Aspartate Aminotransferase Week 0	22.7 IU/L Standard Deviation 6.77
Change From Baseline in Aspartate Aminotransferase Week 6	-3.3 IU/L Standard Deviation 6.37
Change From Baseline in Aspartate Aminotransferase Week 14	-3.1 IU/L Standard Deviation 6.26
Change From Baseline in Aspartate Aminotransferase Week 26	-0.1 IU/L Standard Deviation 6.03

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of total bilirubin in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Total Bilirubin Week 0	0.50 mg/dL Standard Deviation 0.338
Change From Baseline in Total Bilirubin Week 6	-0.03 mg/dL Standard Deviation 0.185
Change From Baseline in Total Bilirubin Week 14	-0.03 mg/dL Standard Deviation 0.212
Change From Baseline in Total Bilirubin Week 26	-0.05 mg/dL Standard Deviation 0.195

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of leukocytes in the blood (x 10^9/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Leukocytes Week 0	6.41 10^9 cells/L Standard Deviation 1.888
Change From Baseline in Leukocytes Week 6	-0.13 10^9 cells/L Standard Deviation 1.397
Change From Baseline in Leukocytes Week 14	0.07 10^9 cells/L Standard Deviation 1.248
Change From Baseline in Leukocytes Week 26	0.01 10^9 cells/L Standard Deviation 1.553

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in erythrocytes in the blood (10^12/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Erythrocytes Week 0	4.610 10^12 cells/L Standard Deviation 0.5315
Change From Baseline in Erythrocytes Week 6	0.018 10^12 cells/L Standard Deviation 0.2687
Change From Baseline in Erythrocytes Week 14	-0.015 10^12 cells/L Standard Deviation 0.2871
Change From Baseline in Erythrocytes Week 26	0.042 10^12 cells/L Standard Deviation 0.2340

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of hemoglobin in the blood (g/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Hemoglobin Week 0	13.83 g/dL Standard Deviation 1.702
Change From Baseline in Hemoglobin Week 6	-0.02 g/dL Standard Deviation 0.789
Change From Baseline in Hemoglobin Week 14	-0.22 g/dL Standard Deviation 0.931
Change From Baseline in Hemoglobin Week 26	0.03 g/dL Standard Deviation 0.814

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in level of hematocrit in the blood (%)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Hematocrit Week 0	43.27 percentage of erythrocytes Standard Deviation 4.636
Change From Baseline in Hematocrit Week 6	-0.70 percentage of erythrocytes Standard Deviation 2.757
Change From Baseline in Hematocrit Week 14	-1.60 percentage of erythrocytes Standard Deviation 2.991
Change From Baseline in Hematocrit Week 26	-1.06 percentage of erythrocytes Standard Deviation 2.737

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in mean corpuscular volume in the blood (fL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Mean Corpuscular Volume Week 0	94.2 fL Standard Deviation 6.35
Change From Baseline in Mean Corpuscular Volume Week 6	-2.0 fL Standard Deviation 2.81
Change From Baseline in Mean Corpuscular Volume Week 14	-3.1 fL Standard Deviation 3.86
Change From Baseline in Mean Corpuscular Volume Week 26	-3.2 fL Standard Deviation 3.82

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in mean corpuscular hemoglobin in the blood (pg)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Mean Corpuscular Hemoglobin Week 0	30.05 pg Standard Deviation 2.119
Change From Baseline in Mean Corpuscular Hemoglobin Week 6	-0.15 pg Standard Deviation 0.697
Change From Baseline in Mean Corpuscular Hemoglobin Week 14	-0.33 pg Standard Deviation 0.530
Change From Baseline in Mean Corpuscular Hemoglobin Week 26	-0.17 pg Standard Deviation 1.004

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in mean corpuscular hemoglobin in the blood (g/dL)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Mean Corpuscular Hemoglobin Concentration Week 0	31.94 g/dL Standard Deviation 1.401
Change From Baseline in Mean Corpuscular Hemoglobin Concentration Week 6	0.47 g/dL Standard Deviation 1.097
Change From Baseline in Mean Corpuscular Hemoglobin Concentration Week 14	0.70 g/dL Standard Deviation 1.476
Change From Baseline in Mean Corpuscular Hemoglobin Concentration Week 26	0.88 g/dL Standard Deviation 1.292

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in erythrocyte distribution width in the blood (%)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Erythrocyte Distribution Width Week 0	14.00 % of erythrocytes Standard Deviation 1.739
Change From Baseline in Erythrocyte Distribution Width Week 6	-1.09 % of erythrocytes Standard Deviation 1.628
Change From Baseline in Erythrocyte Distribution Width Week 14	-1.14 % of erythrocytes Standard Deviation 0.965
Change From Baseline in Erythrocyte Distribution Width Week 26	-1.00 % of erythrocytes Standard Deviation 0.804

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in neutrophils in the blood (%) (leukocyte differential)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Neutrophils Week 0	59.2 percentage of neutrophils in the blood Standard Deviation 8.62
Change From Baseline in Neutrophils Week 6	-0.70 percentage of neutrophils in the blood Standard Deviation 8.123
Change From Baseline in Neutrophils Week 14	-0.40 percentage of neutrophils in the blood Standard Deviation 8.121
Change From Baseline in Neutrophils Week 26	-1.10 percentage of neutrophils in the blood Standard Deviation 8.111

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in lymphocytes in the blood (%) (leukocyte differential)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Lymphocytes Week 0	30.5 percentage of lymphocytes in the blood Standard Deviation 8.15
Change From Baseline in Lymphocytes Week 6	0.27 percentage of lymphocytes in the blood Standard Deviation 7.049
Change From Baseline in Lymphocytes Week 14	-0.19 percentage of lymphocytes in the blood Standard Deviation 7.487
Change From Baseline in Lymphocytes Week 26	0.63 percentage of lymphocytes in the blood Standard Deviation 7.413

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in monocytes in the blood (%) (leukocyte differential)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Monocytes Week 0	7.3 percentage of monocytes in the blood Standard Deviation 1.85
Change From Baseline in Monocytes Week 6	0.05 percentage of monocytes in the blood Standard Deviation 1.765
Change From Baseline in Monocytes Week 14	0.29 percentage of monocytes in the blood Standard Deviation 1.384
Change From Baseline in Monocytes Week 26	0.03 percentage of monocytes in the blood Standard Deviation 1.387

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in eosinophils in the blood (%) (leukocyte differential)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Eosinophils Week 0	2.3 percentage of eosinophils in the blood Standard Deviation 2.14
Change From Baseline in Eosinophils Week 6	0.23 percentage of eosinophils in the blood Standard Deviation 1.118
Change From Baseline in Eosinophils Week 14	-0.02 percentage of eosinophils in the blood Standard Deviation 1.440
Change From Baseline in Eosinophils Week 26	-0.03 percentage of eosinophils in the blood Standard Deviation 1.577

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in basophils in the blood (%) (leukocyte differential)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Basophils Week 0	0.6 percentage of basophils in the blood Standard Deviation 0.55
Change From Baseline in Basophils Week 6	0.18 percentage of basophils in the blood Standard Deviation 0.540
Change From Baseline in Basophils Week 14	0.29 percentage of basophils in the blood Standard Deviation 0.457
Change From Baseline in Basophils Week 26	0.25 percentage of basophils in the blood Standard Deviation 0.439

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected.

Change from baseline in platelets in the blood (x 10^9/L)

Outcome measures

Measure	HB-adMSCs n=51 Participants 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.
Change From Baseline in Platelets Week 0	268.8 10^9 cells/L Standard Deviation 73.48
Change From Baseline in Platelets Week 6	-0.3 10^9 cells/L Standard Deviation 30.85
Change From Baseline in Platelets Week 14	-1.9 10^9 cells/L Standard Deviation 29.50
Change From Baseline in Platelets Week 26	-11.6 10^9 cells/L Standard Deviation 26.06

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected.

Change from baseline in prothrombin time in the blood (seconds)

Outcome measures

Measure	HB-adMSCs n=47 Participants 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.
Change From Baseline in Prothrombin Time Week 0	11.16 seconds Standard Deviation 0.663
Change From Baseline in Prothrombin Time Week 6	-0.08 seconds Standard Deviation 0.596
Change From Baseline in Prothrombin Time Week 14	0.20 seconds Standard Deviation 0.647
Change From Baseline in Prothrombin Time Week 26	0.49 seconds Standard Deviation 0.766

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected.

Change from baseline in international normalized ratio in the blood (INR) (ratio)

Outcome measures

Measure	HB-adMSCs n=47 Participants 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.
Change From Baseline in International Normalized Ratio (INR) Week 0	1.06 ratio Standard Deviation 0.077
Change From Baseline in International Normalized Ratio (INR) Week 6	-0.01 ratio Standard Deviation 0.074
Change From Baseline in International Normalized Ratio (INR) Week 14	0.03 ratio Standard Deviation 0.078
Change From Baseline in International Normalized Ratio (INR) Week 26	0.08 ratio Standard Deviation 0.093

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected.

Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L)

Outcome measures

Measure	HB-adMSCs n=44 Participants 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.
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) Week 0	1.75 ng/L Standard Deviation 4.974
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) Week 6	0.02 ng/L Standard Deviation 0.902
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) Week 14	-0.12 ng/L Standard Deviation 0.759
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) Week 26	-0.26 ng/L Standard Deviation 1.271

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 33. This was the largest N collected.

Change from baseline in Interleukin-6 in the blood (ng/L)

Outcome measures

Measure	HB-adMSCs n=33 Participants 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.
Change From Baseline in Interleukin-6 Week 0	2.5 ng/L Standard Deviation 2.07
Change From Baseline in Interleukin-6 Week 6	0.78 ng/L Standard Deviation 3.071
Change From Baseline in Interleukin-6 Week 14	0.59 ng/L Standard Deviation 2.938
Change From Baseline in Interleukin-6 Week 26	-0.50 ng/L Standard Deviation 2.344

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 27. This was the largest N collected.

Change from baseline in Interleukin-10 in the blood (ng/L)

Outcome measures

Measure	HB-adMSCs n=27 Participants 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.
Change From Baseline in Interleukin-10 Week 0	6.1 ng/L Standard Deviation 2.62
Change From Baseline in Interleukin-10 Week 6	1.63 ng/L Standard Deviation 2.483
Change From Baseline in Interleukin-10 Week 14	0.83 ng/L Standard Deviation 3.074
Change From Baseline in Interleukin-10 Week 26	7.99 ng/L Standard Deviation 21.579

SECONDARY outcome

Timeframe: Weeks 0, 6, 14, 26

Population: At baseline (Week 0), the maximum number analyzed was 24. This was the largest N collected.

Change from baseline in C-Reactive Protein in the blood (mg/dL)

Outcome measures

Measure	HB-adMSCs n=24 Participants 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.
Change From Baseline in C-Reactive Protein Week 0	5.0 mg/dL Standard Deviation 6.69
Change From Baseline in C-Reactive Protein Week 6	-0.26 mg/dL Standard Deviation 1.759
Change From Baseline in C-Reactive Protein Week 14	-0.35 mg/dL Standard Deviation 2.422
Change From Baseline in C-Reactive Protein Week 26	-0.43 mg/dL Standard Deviation 1.342

SECONDARY outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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
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
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
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 36.340

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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 36.890
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
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
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 outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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 21.220
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 22.540
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
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 outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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
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
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
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 13.120

SECONDARY outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
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
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
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
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 16.360
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
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
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
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 outcome

Timeframe: 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.

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

Outcome measures

Measure	HB-adMSCs n=45 Participants 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.
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 0	4.9 score on a scale Standard Deviation 6.43
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 2	-1.67 score on a scale Standard Deviation 5.981
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 6	-1.24 score on a scale Standard Deviation 5.832
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 10	-2.30 score on a scale Standard Deviation 6.081
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 14	-1.81 score on a scale Standard Deviation 7.433
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 18	-2.68 score on a scale Standard Deviation 5.803
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 22	-2.05 score on a scale Standard Deviation 4.190
Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score Week 26	-1.95 score on a scale Standard Deviation 6.569

Adverse Events

HB-adMSCs

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	HB-adMSCs n=51 participants at risk 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.
Infections and infestations Urinary tract infection	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.0% 1/51 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Vascular disorders Embolism	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.

Other adverse events

Measure	HB-adMSCs n=51 participants at risk 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.
General disorders Influenza like illness	27.5% 14/51 • Number of events 26 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
General disorders Fatigue	19.6% 10/51 • Number of events 13 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
General disorders Pyrexia	7.8% 4/51 • Number of events 5 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
General disorders Chills	3.9% 2/51 • Number of events 5 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
General disorders Chest pain	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
General disorders Oedema peripheral	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Headache	41.2% 21/51 • Number of events 45 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Balance disorder	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Dizziness	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Migraine with aura	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Paresthesia	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Nervous system disorders Sinus headache	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 3/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Back pain	5.9% 3/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.9% 2/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Bursitis	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Gastrointestinal disorders Nausea	5.9% 3/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Gastrointestinal disorders Crohn's disease	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Gastrointestinal disorders Diarrhea	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Gastrointestinal disorders Gastric dilatation	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Infections and infestations COVID-19	3.9% 2/51 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Infections and infestations Herpes zoster	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Infections and infestations Upper respiratory tract infection	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Cardiac disorders Palpitations	3.9% 2/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Cardiac disorders Arrhythmia	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Eye disorders Vision blurred	5.9% 3/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Injury, poisoning and procedural complications Fall	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Injury, poisoning and procedural complications Foot fracture	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Injury, poisoning and procedural complications Muscle strain	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Investigations Blood bicarbonate decreased	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Investigations Colonoscopy	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Investigations SARS-CoV-2 antibody test positive	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Metabolism and nutrition disorders Decreased appetite	3.9% 2/51 • Number of events 4 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Metabolism and nutrition disorders Hypoglycemia	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Vascular disorders Hypertension	3.9% 2/51 • Number of events 3 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Blood and lymphatic system disorders Anemia	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Psychiatric disorders Insomnia	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 1/51 • Number of events 2 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/51 • Number of events 1 • Week 0 (Infusion 1) through Week 26 (End of Study) 43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.

Additional Information

Ridhima Vij, PhD

Hope Biosciences Research Foundation

Phone: 346-900-0340

Email: ridhima@hopebio.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place