Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Endothelial dysfunction, Stem cells
Brief summary
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
Interventions
DRUG20 million Allogeneic Mesenchymal Human Stem Cells
1 single intravenous infusion
1 single intravenous infusion
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Joshua M Hare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pilot phase is open label. Randomized phase is blinded.
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Be ≥ 21 and \< 90 (inclusive) years of age. * Provide written informed consent. * Have endothelial dysfunction defined by impaired flow-mediated vasodilation (FMD \<7%). * Have an ejection fraction \> 45% by gated blood pool scan, two- dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the prior 3 months. * Have Diabetes mellitus type 2 documented by hemoglobin adult type 1 component (A1C) \> 7% or on medical therapy for diabetes. * Females of childbearing potential must use two forms of birth control for the duration of the study. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
Exclusion criteria
In order to participate in this study, a subject Must Not: * Be younger than 21 years or older than 90 years of age. * Have a baseline glomerular filtration rate \<35 ml/min 1.73m\^2 estimated using the Modification of Diet in renal disease (MDRD) formula. * Have an ejection fraction \<45% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the past year, as documented by medical history. * Have poorly controlled blood glucose levels with hemoglobin A1C \> 8.5%. * Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment. * Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation. * Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal. * Have a bleeding diathesis or coagulopathy (INR \> 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions. * Have Lymphadenectomy or Lymph node dissection in the right arm. * Be an organ transplant recipient or have a history of organ or cell transplant rejection. * Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively- treated basal cell or squamous cell carcinoma, or cervical carcinoma. * Have a condition that limits lifespan to \< 1 year. * Have a history of drug or alcohol abuse within the past 24 months. * Be on chronic therapy with immunosuppressant medication, such as corticosteroids or Tumor Necrosis Factor - alpha (TNFα) antagonists. * Be serum positive for HIV, Syphilis - VDRL (Confirmation with FTA-ABS if needed (Syphilis)), hepatitis B surface antigen or viremic hepatitis C. * Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial. * Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. * Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | Up to one month (post infusion) | TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP Marker Levels | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L |
| Circulating Angiogenic Factor Levels | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL |
| EPC-CFU Levels | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples |
| Circulating Inflammatory Marker Levels | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL |
| Tumor Necrosis Factor (TNF) Alpha Levels | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | Measured from blood samples (pg/mL) |
| Flow Mediated Diameter Percentage (FMD%) | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 | FMD will be assessed using brachial artery ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Phase 20 Million Allogeneic hMSCs Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 3 |
| Pilot Phase 100 Million hMSCs Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 3 |
| Randomized Phase 20 Million Allogeneic hMSCs Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 5 |
| Randomized Phase 100 Million Allogeneic hMSCs Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs)
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 5 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-up | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Pilot Phase 20 Million Allogeneic hMSCs | Pilot Phase 100 Million hMSCs | Randomized Phase 20 Million Allogeneic hMSCs | Randomized Phase 100 Million Allogeneic hMSCs | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 13.6 | 69.3 years STANDARD_DEVIATION 6.7 | 59.8 years STANDARD_DEVIATION 13.7 | 62.0 years STANDARD_DEVIATION 8.1 | 64.1 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 2 / 3 | 2 / 3 | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 0 / 5 | 1 / 5 |
Outcome results
Primary
Number of Treatment Emergent Serious Adverse Events (TE-SAEs)
TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Time frame: Up to one month (post infusion)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Phase 20 Million Allogeneic hMSCs | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | 0 Treatment Emergent SAE |
| Pilot Phase 100 Million hMSCs | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | 0 Treatment Emergent SAE |
| Randomized Phase 20 Million Allogeneic hMSCs | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | 0 Treatment Emergent SAE |
| Randomized Phase 100 Million Allogeneic hMSCs | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | 0 Treatment Emergent SAE |
Secondary
Circulating Angiogenic Factor Levels
Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
Secondary
Circulating Inflammatory Marker Levels
Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
Secondary
CRP Marker Levels
C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated
Secondary
EPC-CFU Levels
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Not all participants completed required blood draw at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 7 | 9.28 Colony forming units | Standard Deviation 14.21 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 180 | 8.39 Colony forming units | Standard Deviation 7.07 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 14 | 6.11 Colony forming units | Standard Deviation 8.74 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Baseline | 2.06 Colony forming units | Standard Deviation 1.35 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 3 | 3.39 Colony forming units | Standard Deviation 3.31 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 365 | 6.89 Colony forming units | Standard Deviation 4.68 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 90 | 9.17 Colony forming units | Standard Deviation 8.72 |
| Pilot Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 28 | 7.83 Colony forming units | Standard Deviation 5.2 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Baseline | 3.16 Colony forming units | Standard Deviation 1.92 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 3 | 5.50 Colony forming units | Standard Deviation 3.01 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 7 | 6.94 Colony forming units | Standard Deviation 8.67 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 14 | 19.72 Colony forming units | Standard Deviation 17.49 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 28 | 21.83 Colony forming units | Standard Deviation 2.96 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 90 | 14.17 Colony forming units | Standard Deviation 2.32 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 180 | 14.33 Colony forming units | Standard Deviation 3.12 |
| Pilot Phase 100 Million hMSCs | EPC-CFU Levels | Day 365 | 8.83 Colony forming units | Standard Deviation 3.91 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 3 | 4.37 Colony forming units | Standard Deviation 3.2 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 365 | 1.04 Colony forming units | Standard Deviation 0.63 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 180 | 2.45 Colony forming units | Standard Deviation 3.41 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 28 | 2.50 Colony forming units | Standard Deviation 0.96 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 7 | 6.07 Colony forming units | Standard Deviation 3.51 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 90 | 1.90 Colony forming units | Standard Deviation 2.5 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Day 14 | 8.23 Colony forming units | Standard Deviation 4.07 |
| Randomized Phase 20 Million Allogeneic hMSCs | EPC-CFU Levels | Baseline | 2.37 Colony forming units | Standard Deviation 2.6 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 14 | 11.70 Colony forming units | Standard Deviation 11.58 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 28 | 6.70 Colony forming units | Standard Deviation 8.27 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 365 | 2.94 Colony forming units | Standard Deviation 4.25 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 90 | 6.50 Colony forming units | Standard Deviation 8.16 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Baseline | 1.93 Colony forming units | Standard Deviation 1.38 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 7 | 5.53 Colony forming units | Standard Deviation 4.78 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 180 | 4.50 Colony forming units | Standard Deviation 6.46 |
| Randomized Phase 100 Million Allogeneic hMSCs | EPC-CFU Levels | Day 3 | 2.80 Colony forming units | Standard Deviation 1.72 |
Secondary
Flow Mediated Diameter Percentage (FMD%)
FMD will be assessed using brachial artery ultrasound
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Not all participants completed the brachial artery ultrasound at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Baseline | 2.55 Percent dilation of brachial artery | Standard Deviation 1.11 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 28 | 2.33 Percent dilation of brachial artery | Standard Deviation 1.35 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 3 | 2.86 Percent dilation of brachial artery | Standard Deviation 1.96 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 90 | 1.26 Percent dilation of brachial artery | Standard Deviation 0.5 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 7 | 2.97 Percent dilation of brachial artery | Standard Deviation 1.61 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 365 | 1.81 Percent dilation of brachial artery | Standard Deviation 0.24 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 14 | 2.62 Percent dilation of brachial artery | Standard Deviation 0.53 |
| Pilot Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 180 | 2.90 Percent dilation of brachial artery | Standard Deviation 1.74 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Baseline | 4.33 Percent dilation of brachial artery | Standard Deviation 2.61 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 14 | 5.18 Percent dilation of brachial artery | Standard Deviation 3.78 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 28 | 4.45 Percent dilation of brachial artery | Standard Deviation 3.94 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 365 | 4.14 Percent dilation of brachial artery | Standard Deviation 0.38 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 7 | 5.06 Percent dilation of brachial artery | Standard Deviation 3.7 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 180 | 4.32 Percent dilation of brachial artery | Standard Deviation 2.47 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 90 | 4.78 Percent dilation of brachial artery | Standard Deviation 2.49 |
| Pilot Phase 100 Million hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 3 | 4.76 Percent dilation of brachial artery | Standard Deviation 1.46 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 90 | 5.65 Percent dilation of brachial artery | Standard Deviation 2.89 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 180 | 5.78 Percent dilation of brachial artery | Standard Deviation 3.11 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 3 | 5.19 Percent dilation of brachial artery | Standard Deviation 1.33 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 365 | 3.88 Percent dilation of brachial artery | Standard Deviation 1.61 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 7 | 4.80 Percent dilation of brachial artery | Standard Deviation 0.98 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Baseline | 4.55 Percent dilation of brachial artery | Standard Deviation 1.17 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 14 | 5.10 Percent dilation of brachial artery | Standard Deviation 1.55 |
| Randomized Phase 20 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 28 | 5.67 Percent dilation of brachial artery | Standard Deviation 2.63 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 365 | 3.65 Percent dilation of brachial artery | Standard Deviation 1.75 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Baseline | 3.11 Percent dilation of brachial artery | Standard Deviation 1.92 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 3 | 4.99 Percent dilation of brachial artery | Standard Deviation 1.98 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 7 | 5.35 Percent dilation of brachial artery | Standard Deviation 2.45 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 14 | 4.94 Percent dilation of brachial artery | Standard Deviation 1.5 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 28 | 6.19 Percent dilation of brachial artery | Standard Deviation 2.53 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 90 | 5.34 Percent dilation of brachial artery | Standard Deviation 2.44 |
| Randomized Phase 100 Million Allogeneic hMSCs | Flow Mediated Diameter Percentage (FMD%) | Day 180 | 4.04 Percent dilation of brachial artery | Standard Deviation 1.84 |
Secondary
Tumor Necrosis Factor (TNF) Alpha Levels
Measured from blood samples (pg/mL)
Time frame: At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365
Population: Not all participants completed required blood draw at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Baseline | 0.79 pg/mL | Standard Deviation 0.13 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 3 | 0.74 pg/mL | Standard Deviation 0.04 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 7 | 0.77 pg/mL | Standard Deviation 0.03 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 14 | 0.80 pg/mL | Standard Deviation 0.04 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 28 | 0.69 pg/mL | Standard Deviation 0.2 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 90 | 0.68 pg/mL | Standard Deviation 0.15 |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 180 | 17.10 pg/mL | — |
| Pilot Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 365 | 0.83 pg/mL | Standard Deviation 0.23 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 90 | 0.81 pg/mL | Standard Deviation 0.13 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 28 | 0.84 pg/mL | Standard Deviation 0.17 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 3 | 0.86 pg/mL | Standard Deviation 0.33 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 365 | 0.95 pg/mL | Standard Deviation 0.32 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 180 | 0.98 pg/mL | Standard Deviation 0.51 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 14 | 1.01 pg/mL | Standard Deviation 0.2 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 7 | 0.74 pg/mL | Standard Deviation 0.09 |
| Pilot Phase 100 Million hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Baseline | 0.80 pg/mL | Standard Deviation 0.19 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 180 | 0.79 pg/mL | Standard Deviation 0.25 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 7 | 0.90 pg/mL | Standard Deviation 0.45 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 14 | 0.93 pg/mL | Standard Deviation 0.41 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 28 | 0.84 pg/mL | Standard Deviation 0.31 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 90 | 0.83 pg/mL | Standard Deviation 0.1 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 365 | 0.76 pg/mL | Standard Deviation 0.08 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Baseline | 0.85 pg/mL | Standard Deviation 0.21 |
| Randomized Phase 20 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 3 | 1.01 pg/mL | Standard Deviation 0.24 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 7 | 1.09 pg/mL | Standard Deviation 0.55 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 14 | 0.90 pg/mL | Standard Deviation 0.33 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 3 | 0.81 pg/mL | Standard Deviation 0.15 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Baseline | 0.80 pg/mL | Standard Deviation 0.12 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 28 | 0.82 pg/mL | Standard Deviation 0.19 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 365 | 0.81 pg/mL | Standard Deviation 0.23 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 180 | 0.76 pg/mL | Standard Deviation 0.1 |
| Randomized Phase 100 Million Allogeneic hMSCs | Tumor Necrosis Factor (TNF) Alpha Levels | Day 90 | 0.71 pg/mL | Standard Deviation 0.12 |