COVID-19
Conditions
Keywords
Coronavirus, Stem cells, Mesenchymal stem cells, Adipose-derived mesenchymal stem cells, MSCs, COVID, SARS-CoV-2, Coronavirus disease
Brief summary
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.
Detailed description
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.
Interventions
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
Saline
Sponsors
Study design
Eligibility
Inclusion criteria
1. Men, and women, over 18 years of age inclusively. 2. Patient is suspected to have COVID-19 infection. 3. Provides consent or consent is given by their legally authorized representative (LAR). 4. Agrees to the collection of venous blood per protocol. 5. Women of childbearing potential (WOCBP) and men (if their sexual partners are WOCBP) must use at least 1 highly effective form of birth control throughout the study and for 6 months after the last dose of study treatment. Highly effective methods of birth control include true sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk, in line with the preferred and usual lifestyle of the patient), surgery (bilateral tubal ligation or occlusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive associated with inhibition of ovulation (oral, patch, injectable, implantable, or intravaginal), intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
Exclusion criteria
1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. Absence of pregnancy will be confirmed through urine pregnancy test. 2. Patients who have participated or are participating in a clinical trial of an experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days. 3. Inability to provide informed consent or to comply with study requirements. 4. Patients with the following concomitant or past medical history: * Both Hypertension and Diabetes Mellitus. * Both Hypertension and Chronic Kidney Disease. * Both Diabetes Mellitus and Chronic Kidney Disease. 5. History or evidence of alcohol abuse. 6. History or evidence of consumption of illicit drugs. 7. Patients requiring mechanical ventilation. 8. Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons. 9. Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return To Room Air (RTRA) | Day 0, 3, 7, and 10 | Number of participants who returned to room air |
| Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 0, 3, 7, and 10 | Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL) |
| Interleukin-10 (IL-10) | Day 0, 3, 7, and 10 | Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL) |
| Interleukin-6 (IL-6) | Day 0, 3, 7, and 10 | Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL) |
| C-Reactive Protein (CRP) | Day 0, 3, 7, and 10 | Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L) |
| Oxygenation | Day 0, 3, 7, and 10 | Change from baseline Oxygenation (%) in the blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4+/CD8+ Ratio | Day 0, 3, 7, and 10 | Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood |
| 7-Point Ordinal Scale | Day 0, 3, 7, 10, and 28 (End of Study) | Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities. |
| Computed Tomography (CT) Score | Day 0 and Day 28 | Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. |
| Chest X-Ray Score | Day 0, Day 28 | Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. |
| Glucose | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Glucose in the blood (mg/dL) |
| Blood Urea Nitrogen (BUN) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL) |
| Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73) |
| Estimated Glomerular Filtration Rate (eGFR) if African American | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73) |
| BUN/Creatinine Ratio | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of BUN/Creatinine Ratio in the blood |
| Sodium | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Sodium in the blood (mmol/L) |
| Potassium | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Potassium in the blood (mmol/L) |
| Chloride | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Chloride in the blood (mmol/L) |
| Carbon Dioxide Total | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L) |
| Calcium | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Calcium in the blood (mg/dL) |
| Protein Total | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of total level of Protein in the blood (g/dL) |
| Albumin | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Albumin in the blood (g/dL) |
| Globulin Total | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of the total level of Globulin in the blood (g/dL) |
| Albumin/Globulin (A/G) Ratio | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood |
| Bilirubin Total | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL) |
| Alkaline Phosphatase | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L) |
| Aspartate Aminotransferase (SGOT) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L) |
| Alanine Aminotransferase (SGPT) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L) |
| White Blood Count (WBC) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10\^3/uL) |
| Red Blood Cell (RBC) Count | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10\^3/uL) |
| Hemoglobin | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Hemoglobin in the blood (g/dL) |
| Hematocrit | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Hematocrit in the blood (%) |
| Mean Corpuscular Volume (MCV) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL) |
| Mean Corpuscular Hemoglobin (MCH) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg) |
| Mean Corpuscular Hemoglobin Concentration (MCHC) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL) |
| Red Cell Distribution Width (RDW) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%) |
| Platelets | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Platelets in the blood (cells x10\^3/uL) |
| Neutrophils | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Neutrophils in the blood (%) |
| Lymphocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Lymphocytes in the blood (%) |
| Monocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Monocytes in the blood (%) |
| Eosinophils | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Eosinophils n the blood (%) |
| Basophils | Screening, Day 0, 3, 7 and 10 | Clinical lab evaluation of level of Basophils in the blood (%) |
| Absolute Neutrophils | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10\^3/uL) |
| Absolute Lymphocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10\^3/uL) |
| Absolute Monocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10\^3/uL) |
| Absolute Eosinophils | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10\^3/uL) |
| Absolute Basophils | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10\^3/uL) |
| Immature Granulocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Immature Granulocytes in the blood (%) |
| Absolute Immature Granulocytes | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10\^3/uL) |
| International Normalized Ratio (INR) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of International Normalized Ratio (INR) |
| D-dimer | Day 0, 3, 7, and Day 10 | Change from baseline in D-dimer in the blood (mg/L) |
| Partial Thromboplastin Time (PTT) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds) |
| Prothrombin Time (PT) | Screening, Day 0, 3, 7, and 10 | Clinical lab evaluation of Prothrombin Time (seconds) |
| Myoglobin | Day 0, 3 7, and 10 | Clinical lab evaluation of level of Myoglobin in the blood (ng/mL) |
| Troponin | Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Troponin in the blood (ng/mL) |
| Creatinine Kinase MB (CK-MB) | Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL) |
| Serum Ferritin | Day 0, 3, 7, and 10 | Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL) |
| NK Cell Surface Antigen (CD3-CD56+) | Day 0, 3, 7, and 10 | Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%) |
Countries
United States
Participant flow
Recruitment details
A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening. All 48 were randomized in to the two treatment arms: 100MM HB-adMSCs and placebo. 21 out of 48 randomized subjects discontinued.
Pre-assignment details
A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening.
Participants by arm
| Arm | Count |
|---|---|
| HB-adMSCs Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 33 |
| Placebo Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Placebo: Saline | 15 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 4 | 1 |
| Overall Study | Discharge or Transfer to other Hospital | 3 | 0 |
| Overall Study | FDA Clinical Hold | 7 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | HB-adMSCs | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.2 Years STANDARD_DEVIATION 17.6 | 54.7 Years STANDARD_DEVIATION 15.8 | 53.7 Years STANDARD_DEVIATION 16.9 |
| Body Mass Index (BMI) | 30.8 kg/m^2 STANDARD_DEVIATION 6.3 | 31.2 kg/m^2 STANDARD_DEVIATION 5.9 | 30.9 kg/m^2 STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 6 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 66.5 in STANDARD_DEVIATION 3.5 | 66.1 in STANDARD_DEVIATION 4.4 | 66.4 in STANDARD_DEVIATION 3.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 11 Participants | 32 Participants |
| Sex: Female, Male Female | 15 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 18 Participants | 10 Participants | 28 Participants |
| Weight | 194.6 lbs STANDARD_DEVIATION 48.2 | 194.1 lbs STANDARD_DEVIATION 43.7 | 194.4 lbs STANDARD_DEVIATION 46.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 33 | 2 / 15 |
| other Total, other adverse events | 27 / 33 | 12 / 15 |
| serious Total, serious adverse events | 9 / 33 | 2 / 15 |
Outcome results
C-Reactive Protein (CRP)
Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | C-Reactive Protein (CRP) | Day 0 (Baseline) | 4.9 mg/L | Standard Deviation 5.8 |
| HB-adMSCs | C-Reactive Protein (CRP) | Day 3 | 4.8 mg/L | Standard Deviation 7.5 |
| HB-adMSCs | C-Reactive Protein (CRP) | Day 7 | 3.6 mg/L | Standard Deviation 3.4 |
| HB-adMSCs | C-Reactive Protein (CRP) | Day 10 | 3.5 mg/L | Standard Deviation 4.8 |
| Placebo | C-Reactive Protein (CRP) | Day 10 | 0.2 mg/L | Standard Deviation 0.2 |
| Placebo | C-Reactive Protein (CRP) | Day 0 (Baseline) | 3.8 mg/L | Standard Deviation 5.1 |
| Placebo | C-Reactive Protein (CRP) | Day 7 | 2.2 mg/L | Standard Deviation 4.1 |
| Placebo | C-Reactive Protein (CRP) | Day 3 | 4.5 mg/L | Standard Deviation 9.2 |
Interleukin-10 (IL-10)
Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Interleukin-10 (IL-10) | Day 0 (Baseline) | 16.3 pg/mL | Standard Deviation 19.4 |
| HB-adMSCs | Interleukin-10 (IL-10) | Day 3 | 18.8 pg/mL | Standard Deviation 39.1 |
| HB-adMSCs | Interleukin-10 (IL-10) | Day 7 | 30.8 pg/mL | Standard Deviation 86.3 |
| HB-adMSCs | Interleukin-10 (IL-10) | Day 10 | 13.0 pg/mL | Standard Deviation 13.5 |
| Placebo | Interleukin-10 (IL-10) | Day 10 | 8.4 pg/mL | Standard Deviation 10.8 |
| Placebo | Interleukin-10 (IL-10) | Day 0 (Baseline) | 11.9 pg/mL | Standard Deviation 16.6 |
| Placebo | Interleukin-10 (IL-10) | Day 7 | 27.2 pg/mL | Standard Deviation 65.1 |
| Placebo | Interleukin-10 (IL-10) | Day 3 | 44.7 pg/mL | Standard Deviation 98.9 |
Interleukin-6 (IL-6)
Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Interleukin-6 (IL-6) | Day 0 (Baseline) | 24.3 pg/mL | Standard Deviation 71.8 |
| HB-adMSCs | Interleukin-6 (IL-6) | Day 3 | 46.3 pg/mL | Standard Deviation 104 |
| HB-adMSCs | Interleukin-6 (IL-6) | Day 7 | 65.4 pg/mL | Standard Deviation 186.8 |
| HB-adMSCs | Interleukin-6 (IL-6) | Day 10 | 35.0 pg/mL | Standard Deviation 70.4 |
| Placebo | Interleukin-6 (IL-6) | Day 10 | 12.4 pg/mL | Standard Deviation 23.9 |
| Placebo | Interleukin-6 (IL-6) | Day 0 (Baseline) | 69.4 pg/mL | Standard Deviation 166.5 |
| Placebo | Interleukin-6 (IL-6) | Day 7 | 197.8 pg/mL | Standard Deviation 539.7 |
| Placebo | Interleukin-6 (IL-6) | Day 3 | 376.6 pg/mL | Standard Deviation 988.7 |
Oxygenation
Change from baseline Oxygenation (%) in the blood
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Oxygenation | Day 0 (Baseline) | 95.3 % of Oxygen Saturation | Standard Deviation 3.1 |
| HB-adMSCs | Oxygenation | Day 7 | 96.2 % of Oxygen Saturation | Standard Deviation 2.2 |
| HB-adMSCs | Oxygenation | Day 3 | 95.4 % of Oxygen Saturation | Standard Deviation 3.2 |
| HB-adMSCs | Oxygenation | Day 10 | 96.7 % of Oxygen Saturation | Standard Deviation 2.5 |
| Placebo | Oxygenation | Day 3 | 94.5 % of Oxygen Saturation | Standard Deviation 4.7 |
| Placebo | Oxygenation | Day 0 (Baseline) | 89.4 % of Oxygen Saturation | Standard Deviation 19.1 |
| Placebo | Oxygenation | Day 10 | 96.7 % of Oxygen Saturation | Standard Deviation 1.7 |
| Placebo | Oxygenation | Day 7 | 95.8 % of Oxygen Saturation | Standard Deviation 5.7 |
Return To Room Air (RTRA)
Number of participants who returned to room air
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HB-adMSCs | Return To Room Air (RTRA) | Day 0 | 15 Participants |
| HB-adMSCs | Return To Room Air (RTRA) | Day 3 | 13 Participants |
| HB-adMSCs | Return To Room Air (RTRA) | Day 7 | 11 Participants |
| HB-adMSCs | Return To Room Air (RTRA) | Day 10 | 12 Participants |
| Placebo | Return To Room Air (RTRA) | Day 10 | 8 Participants |
| Placebo | Return To Room Air (RTRA) | Day 0 | 4 Participants |
| Placebo | Return To Room Air (RTRA) | Day 7 | 7 Participants |
| Placebo | Return To Room Air (RTRA) | Day 3 | 8 Participants |
Tumor Necrosis Factor-Alpha (TNF-alpha)
Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 10 | 20.3 pg/mL | Standard Deviation 11.3 |
| HB-adMSCs | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 3 | 26.1 pg/mL | Standard Deviation 26.5 |
| HB-adMSCs | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 7 | 33.4 pg/mL | Standard Deviation 49.8 |
| HB-adMSCs | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 0 (Baseline) | 15.5 pg/mL | Standard Deviation 13.9 |
| Placebo | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 10 | 30.5 pg/mL | Standard Deviation 40.5 |
| Placebo | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 0 (Baseline) | 18.2 pg/mL | Standard Deviation 12.3 |
| Placebo | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 3 | 15.9 pg/mL | Standard Deviation 10 |
| Placebo | Tumor Necrosis Factor-Alpha (TNF-alpha) | Day 7 | 35.3 pg/mL | Standard Deviation 38.8 |
7-Point Ordinal Scale
Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities.
Time frame: Day 0, 3, 7, 10, and 28 (End of Study)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HB-adMSCs | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 28 (End of Study) | 9 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 10 | 4 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 0 | 2 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study) | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 0 | 8 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 0 | 6 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 10 | 6 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 3 | 4 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 3 | 3 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 7 | 5 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 3 | 9 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 10 | 2 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 7 | 2 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study) | 0 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 7 | 3 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 0 | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 10 | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 3 | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 7 | 14 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 7 | 0 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study) | 0 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 10 | 2 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 28 (End of Study) | 14 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study) | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 0 | 15 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 7: Death - Day 0 | 0 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 10 | 12 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 7: Death - Day 3 | 1 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 3 | 12 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 7: Death - Day 7 | 4 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 3 | 3 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 7: Death - Day 10 | 6 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 7 | 5 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 7: Death - Day 28 (End of Study) | 8 Participants |
| HB-adMSCs | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 0 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 7: Death - Day 28 (End of Study) | 2 Participants |
| Placebo | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 0 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 3 | 3 Participants |
| Placebo | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 7 | 5 Participants |
| Placebo | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 10 | 5 Participants |
| Placebo | 7-Point Ordinal Scale | 1: Not hospitalized, no limitations on activities - Day 28 (End of Study) | 7 Participants |
| Placebo | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 0 | 4 Participants |
| Placebo | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 3 | 5 Participants |
| Placebo | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 7 | 7 Participants |
| Placebo | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 10 | 7 Participants |
| Placebo | 7-Point Ordinal Scale | 2: Not hospitalized, limitation on activities - Day 28 (End of Study) | 6 Participants |
| Placebo | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 0 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 3 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 7 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 10 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study) | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 0 | 8 Participants |
| Placebo | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 3 | 6 Participants |
| Placebo | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 7 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 10 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study) | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 0 | 2 Participants |
| Placebo | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 3 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 7 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 10 | 2 Participants |
| Placebo | 7-Point Ordinal Scale | 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study) | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 0 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 3 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 7 | 1 Participants |
| Placebo | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 10 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study) | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 7: Death - Day 0 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 7: Death - Day 3 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 7: Death - Day 7 | 0 Participants |
| Placebo | 7-Point Ordinal Scale | 7: Death - Day 10 | 1 Participants |
Absolute Basophils
Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Basophils was collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Basophils | Day 10 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Basophils | Screening | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Basophils | Day 0 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Basophils | Day 3 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Basophils | Day 7 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| Placebo | Absolute Basophils | Screening | 0.0 cells x10^3/uL | Standard Deviation 0 |
| Placebo | Absolute Basophils | Day 3 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| Placebo | Absolute Basophils | Day 0 | 0.0 cells x10^3/uL | Standard Deviation 0 |
Absolute Eosinophils
Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Eosinophils was collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Eosinophils | Day 10 | 0.1 cells x10^3/uL | Standard Deviation 0.1 |
| HB-adMSCs | Absolute Eosinophils | Day 3 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Eosinophils | Day 7 | 0.0 cells x10^3/uL | Standard Deviation 0.1 |
| HB-adMSCs | Absolute Eosinophils | Screening | 0.1 cells x10^3/uL | Standard Deviation 0.3 |
| HB-adMSCs | Absolute Eosinophils | Day 0 | 0.0 cells x10^3/uL | Standard Deviation 0 |
| Placebo | Absolute Eosinophils | Screening | 0.0 cells x10^3/uL | Standard Deviation 0 |
| Placebo | Absolute Eosinophils | Day 3 | 0.1 cells x10^3/uL | Standard Deviation 0.2 |
| Placebo | Absolute Eosinophils | Day 0 | 0.0 cells x10^3/uL | Standard Deviation 0 |
Absolute Immature Granulocytes
Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening.These were the largest N for which data was collected for Absolute Immature Granulocytes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Immature Granulocytes | Day 10 | 0.0 cells x10^3/uL | Standard Deviation 0.1 |
| HB-adMSCs | Absolute Immature Granulocytes | Day 3 | 0.2 cells x10^3/uL | Standard Deviation 0.2 |
| HB-adMSCs | Absolute Immature Granulocytes | Day 7 | 0.1 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Immature Granulocytes | Screening | 0.0 cells x10^3/uL | Standard Deviation 0 |
| HB-adMSCs | Absolute Immature Granulocytes | Day 0 | 0.1 cells x10^3/uL | Standard Deviation 0.2 |
| Placebo | Absolute Immature Granulocytes | Screening | 0.1 cells x10^3/uL | Standard Deviation 0.2 |
| Placebo | Absolute Immature Granulocytes | Day 3 | 0.3 cells x10^3/uL | Standard Deviation 0.5 |
| Placebo | Absolute Immature Granulocytes | Day 0 | 0.2 cells x10^3/uL | Standard Deviation 0.2 |
Absolute Lymphocytes
Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 11 at screening. These were the largest N collected for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Lymphocytes | Screening | 1.0 cells x10^3/uL | Standard Deviation 0.6 |
| HB-adMSCs | Absolute Lymphocytes | Day 0 | 1.0 cells x10^3/uL | Standard Deviation 0.6 |
| HB-adMSCs | Absolute Lymphocytes | Day 3 | 1.0 cells x10^3/uL | Standard Deviation 0.7 |
| HB-adMSCs | Absolute Lymphocytes | Day 7 | 0.8 cells x10^3/uL | Standard Deviation 0.3 |
| HB-adMSCs | Absolute Lymphocytes | Day 10 | 261.1 cells x10^3/uL | Standard Deviation 580.8 |
| Placebo | Absolute Lymphocytes | Screening | 1.1 cells x10^3/uL | Standard Deviation 1.1 |
| Placebo | Absolute Lymphocytes | Day 3 | 1.9 cells x10^3/uL | Standard Deviation 1.4 |
| Placebo | Absolute Lymphocytes | Day 0 | 1.4 cells x10^3/uL | Standard Deviation 1.1 |
| Placebo | Absolute Lymphocytes | Day 10 | 2184.0 cells x10^3/uL | — |
Absolute Monocytes
Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Monocytes was collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Monocytes | Day 10 | 0.6 cells x10^3/uL | Standard Deviation 0.4 |
| HB-adMSCs | Absolute Monocytes | Day 3 | 0.7 cells x10^3/uL | Standard Deviation 0.5 |
| HB-adMSCs | Absolute Monocytes | Day 7 | 0.6 cells x10^3/uL | Standard Deviation 0.6 |
| HB-adMSCs | Absolute Monocytes | Screening | 0.4 cells x10^3/uL | Standard Deviation 0.3 |
| HB-adMSCs | Absolute Monocytes | Day 0 | 1.1 cells x10^3/uL | Standard Deviation 2.5 |
| Placebo | Absolute Monocytes | Screening | 0.5 cells x10^3/uL | Standard Deviation 0.4 |
| Placebo | Absolute Monocytes | Day 3 | 0.8 cells x10^3/uL | Standard Deviation 0.4 |
| Placebo | Absolute Monocytes | Day 0 | 0.5 cells x10^3/uL | Standard Deviation 0.4 |
Absolute Neutrophils
Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at Day screening and in Placebo group maximum number analyzed was 10 at Screening. These were the largest N collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Absolute Neutrophils | Day 10 | 5.3 cells x 10^3/uL | Standard Deviation 4.2 |
| HB-adMSCs | Absolute Neutrophils | Day 3 | 15.4 cells x 10^3/uL | Standard Deviation 15.6 |
| HB-adMSCs | Absolute Neutrophils | Day 7 | 7.4 cells x 10^3/uL | Standard Deviation 4.7 |
| HB-adMSCs | Absolute Neutrophils | Screening | 7.0 cells x 10^3/uL | Standard Deviation 3.8 |
| HB-adMSCs | Absolute Neutrophils | Day 0 | 9.7 cells x 10^3/uL | Standard Deviation 10.3 |
| Placebo | Absolute Neutrophils | Screening | 7.5 cells x 10^3/uL | Standard Deviation 4.2 |
| Placebo | Absolute Neutrophils | Day 3 | 13.6 cells x 10^3/uL | Standard Deviation 11.5 |
| Placebo | Absolute Neutrophils | Day 0 | 7.6 cells x 10^3/uL | Standard Deviation 3.4 |
Alanine Aminotransferase (SGPT)
Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Alanine Aminotransferase (SGPT) | Day 0 | 38.5 IU/L | Standard Deviation 39.7 |
| HB-adMSCs | Alanine Aminotransferase (SGPT) | Day 7 | 46.4 IU/L | Standard Deviation 39.7 |
| HB-adMSCs | Alanine Aminotransferase (SGPT) | Screening | 50.8 IU/L | Standard Deviation 58.3 |
| HB-adMSCs | Alanine Aminotransferase (SGPT) | Day 10 | 42.2 IU/L | Standard Deviation 29.3 |
| HB-adMSCs | Alanine Aminotransferase (SGPT) | Day 3 | 68.0 IU/L | Standard Deviation 78.8 |
| Placebo | Alanine Aminotransferase (SGPT) | Day 10 | 70.8 IU/L | Standard Deviation 83.4 |
| Placebo | Alanine Aminotransferase (SGPT) | Day 0 | 57.2 IU/L | Standard Deviation 38.6 |
| Placebo | Alanine Aminotransferase (SGPT) | Day 3 | 107.0 IU/L | Standard Deviation 122.3 |
| Placebo | Alanine Aminotransferase (SGPT) | Day 7 | 108.7 IU/L | Standard Deviation 106.2 |
| Placebo | Alanine Aminotransferase (SGPT) | Screening | 77.0 IU/L | Standard Deviation 124.5 |
Albumin
Clinical lab evaluation of level of Albumin in the blood (g/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Albumin | Day 0 | 3.4 g/dL | Standard Deviation 0.5 |
| HB-adMSCs | Albumin | Day 7 | 3.2 g/dL | Standard Deviation 0.8 |
| HB-adMSCs | Albumin | Day 3 | 3.2 g/dL | Standard Deviation 0.7 |
| HB-adMSCs | Albumin | Day 10 | 3.4 g/dL | Standard Deviation 0.8 |
| HB-adMSCs | Albumin | Screening | 3.4 g/dL | Standard Deviation 0.5 |
| Placebo | Albumin | Day 10 | 3.9 g/dL | Standard Deviation 0.4 |
| Placebo | Albumin | Screening | 3.6 g/dL | Standard Deviation 0.6 |
| Placebo | Albumin | Day 0 | 3.5 g/dL | Standard Deviation 0.6 |
| Placebo | Albumin | Day 3 | 3.4 g/dL | Standard Deviation 0.6 |
| Placebo | Albumin | Day 7 | 3.5 g/dL | Standard Deviation 0.8 |
Albumin/Globulin (A/G) Ratio
Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 14 (at Day 7) and in Placebo group maximum number analyzed was 8 at (Day 10). These were the largest N collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Albumin/Globulin (A/G) Ratio | Day 3 | 1.5 Ratio | Standard Deviation 0.4 |
| HB-adMSCs | Albumin/Globulin (A/G) Ratio | Day 0 | 1.4 Ratio | Standard Deviation 0.3 |
| HB-adMSCs | Albumin/Globulin (A/G) Ratio | Day 7 | 1.4 Ratio | Standard Deviation 0.3 |
| HB-adMSCs | Albumin/Globulin (A/G) Ratio | Day 10 | 1.3 Ratio | Standard Deviation 0.4 |
| Placebo | Albumin/Globulin (A/G) Ratio | Day 10 | 1.7 Ratio | Standard Deviation 0.4 |
| Placebo | Albumin/Globulin (A/G) Ratio | Day 0 | 1.3 Ratio | Standard Deviation 0.3 |
| Placebo | Albumin/Globulin (A/G) Ratio | Day 3 | 1.5 Ratio | Standard Deviation 0.4 |
| Placebo | Albumin/Globulin (A/G) Ratio | Day 7 | 1.4 Ratio | Standard Deviation 0.4 |
| Unknown | Albumin/Globulin (A/G) Ratio | Screening | — Ratio | — |
Alkaline Phosphatase
Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Alkaline Phosphatase | Day 0 | 84.9 IU/L | Standard Deviation 35.3 |
| HB-adMSCs | Alkaline Phosphatase | Day 7 | 83.9 IU/L | Standard Deviation 35 |
| HB-adMSCs | Alkaline Phosphatase | Day 3 | 101.8 IU/L | Standard Deviation 71.1 |
| HB-adMSCs | Alkaline Phosphatase | Day 10 | 94.2 IU/L | Standard Deviation 47.3 |
| HB-adMSCs | Alkaline Phosphatase | Screening | 85.5 IU/L | Standard Deviation 37.2 |
| Placebo | Alkaline Phosphatase | Day 10 | 79.1 IU/L | Standard Deviation 19.3 |
| Placebo | Alkaline Phosphatase | Screening | 71.9 IU/L | Standard Deviation 19.8 |
| Placebo | Alkaline Phosphatase | Day 0 | 66.5 IU/L | Standard Deviation 21.6 |
| Placebo | Alkaline Phosphatase | Day 3 | 67.7 IU/L | Standard Deviation 22.1 |
| Placebo | Alkaline Phosphatase | Day 7 | 86.6 IU/L | Standard Deviation 15.2 |
Aspartate Aminotransferase (SGOT)
Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Aspartate Aminotransferase (SGOT) | Day 7 | 41.4 IU/L | Standard Deviation 52.7 |
| HB-adMSCs | Aspartate Aminotransferase (SGOT) | Screening | 41.9 IU/L | Standard Deviation 33.3 |
| HB-adMSCs | Aspartate Aminotransferase (SGOT) | Day 3 | 69.7 IU/L | Standard Deviation 117.3 |
| HB-adMSCs | Aspartate Aminotransferase (SGOT) | Day 10 | 36.6 IU/L | Standard Deviation 20 |
| HB-adMSCs | Aspartate Aminotransferase (SGOT) | Day 0 | 30.0 IU/L | Standard Deviation 18.3 |
| Placebo | Aspartate Aminotransferase (SGOT) | Day 10 | 27.6 IU/L | Standard Deviation 10.1 |
| Placebo | Aspartate Aminotransferase (SGOT) | Day 0 | 38.2 IU/L | Standard Deviation 26.4 |
| Placebo | Aspartate Aminotransferase (SGOT) | Day 3 | 47.3 IU/L | Standard Deviation 33.9 |
| Placebo | Aspartate Aminotransferase (SGOT) | Day 7 | 46.1 IU/L | Standard Deviation 32.8 |
| Placebo | Aspartate Aminotransferase (SGOT) | Screening | 41.1 IU/L | Standard Deviation 28.2 |
Basophils
Clinical lab evaluation of level of Basophils in the blood (%)
Time frame: Screening, Day 0, 3, 7 and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Basophils | Day 0 | 0.1 % of Basophils | Standard Deviation 0.4 |
| HB-adMSCs | Basophils | Day 7 | 0.4 % of Basophils | Standard Deviation 0.7 |
| HB-adMSCs | Basophils | Day 3 | 0.2 % of Basophils | Standard Deviation 0.3 |
| HB-adMSCs | Basophils | Day 10 | 0.4 % of Basophils | Standard Deviation 0.9 |
| HB-adMSCs | Basophils | Screening | 0.3 % of Basophils | Standard Deviation 0.4 |
| Placebo | Basophils | Day 10 | 0.2 % of Basophils | Standard Deviation 0.3 |
| Placebo | Basophils | Screening | 0.1 % of Basophils | Standard Deviation 0.2 |
| Placebo | Basophils | Day 0 | 0.1 % of Basophils | Standard Deviation 0.3 |
| Placebo | Basophils | Day 3 | 0.0 % of Basophils | Standard Deviation 0 |
| Placebo | Basophils | Day 7 | 0.8 % of Basophils | Standard Deviation 0.9 |
Bilirubin Total
Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Bilirubin Total | Day 3 | 0.7 mg/dL | Standard Deviation 0.8 |
| HB-adMSCs | Bilirubin Total | Day 7 | 0.5 mg/dL | Standard Deviation 0.2 |
| HB-adMSCs | Bilirubin Total | Day 10 | 0.5 mg/dL | Standard Deviation 0.2 |
| HB-adMSCs | Bilirubin Total | Screening | 0.6 mg/dL | Standard Deviation 0.4 |
| HB-adMSCs | Bilirubin Total | Day 0 | 0.4 mg/dL | Standard Deviation 0.2 |
| Placebo | Bilirubin Total | Day 0 | 0.4 mg/dL | Standard Deviation 0.3 |
| Placebo | Bilirubin Total | Screening | 0.5 mg/dL | Standard Deviation 0.2 |
| Placebo | Bilirubin Total | Day 7 | 0.5 mg/dL | Standard Deviation 0.4 |
| Placebo | Bilirubin Total | Day 3 | 0.4 mg/dL | Standard Deviation 0.2 |
| Placebo | Bilirubin Total | Day 10 | 0.6 mg/dL | Standard Deviation 0.5 |
Blood Urea Nitrogen (BUN)
Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Blood Urea Nitrogen (BUN) | Day 0 | 22.9 mg/dL | Standard Deviation 17.4 |
| HB-adMSCs | Blood Urea Nitrogen (BUN) | Day 7 | 28.4 mg/dL | Standard Deviation 28.1 |
| HB-adMSCs | Blood Urea Nitrogen (BUN) | Day 3 | 24.0 mg/dL | Standard Deviation 18.5 |
| HB-adMSCs | Blood Urea Nitrogen (BUN) | Day 10 | 19.8 mg/dL | Standard Deviation 12.1 |
| HB-adMSCs | Blood Urea Nitrogen (BUN) | Screening | 19.7 mg/dL | Standard Deviation 14.3 |
| Placebo | Blood Urea Nitrogen (BUN) | Day 10 | 14.9 mg/dL | Standard Deviation 6 |
| Placebo | Blood Urea Nitrogen (BUN) | Screening | 14.3 mg/dL | Standard Deviation 5.8 |
| Placebo | Blood Urea Nitrogen (BUN) | Day 0 | 15.6 mg/dL | Standard Deviation 4.8 |
| Placebo | Blood Urea Nitrogen (BUN) | Day 3 | 12.7 mg/dL | Standard Deviation 4.4 |
| Placebo | Blood Urea Nitrogen (BUN) | Day 7 | 19.9 mg/dL | Standard Deviation 7.8 |
BUN/Creatinine Ratio
Clinical lab evaluation of BUN/Creatinine Ratio in the blood
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | BUN/Creatinine Ratio | Day 0 | 22.9 Ratio | Standard Deviation 11 |
| HB-adMSCs | BUN/Creatinine Ratio | Day 7 | 30.3 Ratio | Standard Deviation 24.6 |
| HB-adMSCs | BUN/Creatinine Ratio | Day 3 | 22.4 Ratio | Standard Deviation 6.9 |
| HB-adMSCs | BUN/Creatinine Ratio | Day 10 | 20.2 Ratio | Standard Deviation 7.9 |
| HB-adMSCs | BUN/Creatinine Ratio | Screening | 18.1 Ratio | Standard Deviation 6.6 |
| Placebo | BUN/Creatinine Ratio | Day 10 | 18.4 Ratio | Standard Deviation 7.6 |
| Placebo | BUN/Creatinine Ratio | Screening | 18.9 Ratio | Standard Deviation 2.7 |
| Placebo | BUN/Creatinine Ratio | Day 0 | 20.7 Ratio | Standard Deviation 4.7 |
| Placebo | BUN/Creatinine Ratio | Day 3 | 19.2 Ratio | Standard Deviation 5.8 |
| Placebo | BUN/Creatinine Ratio | Day 7 | 26.1 Ratio | Standard Deviation 8 |
Calcium
Clinical lab evaluation of level of Calcium in the blood (mg/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Calcium | Day 0 | 8.4 mg/dL | Standard Deviation 0.5 |
| HB-adMSCs | Calcium | Day 7 | 8.4 mg/dL | Standard Deviation 1.1 |
| HB-adMSCs | Calcium | Day 3 | 8.3 mg/dL | Standard Deviation 0.7 |
| HB-adMSCs | Calcium | Day 10 | 8.6 mg/dL | Standard Deviation 1.1 |
| HB-adMSCs | Calcium | Screening | 8.6 mg/dL | Standard Deviation 0.5 |
| Placebo | Calcium | Day 10 | 9.1 mg/dL | Standard Deviation 0.4 |
| Placebo | Calcium | Screening | 8.7 mg/dL | Standard Deviation 0.6 |
| Placebo | Calcium | Day 0 | 8.3 mg/dL | Standard Deviation 0.7 |
| Placebo | Calcium | Day 3 | 8.3 mg/dL | Standard Deviation 0.8 |
| Placebo | Calcium | Day 7 | 8.7 mg/dL | Standard Deviation 0.9 |
Carbon Dioxide Total
Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Carbon Dioxide Total | Day 7 | 23.8 mmol/L | Standard Deviation 3.5 |
| HB-adMSCs | Carbon Dioxide Total | Screening | 25.2 mmol/L | Standard Deviation 4.5 |
| HB-adMSCs | Carbon Dioxide Total | Day 0 | 24.1 mmol/L | Standard Deviation 4.8 |
| HB-adMSCs | Carbon Dioxide Total | Day 3 | 24.6 mmol/L | Standard Deviation 4 |
| HB-adMSCs | Carbon Dioxide Total | Day 10 | 21.9 mmol/L | Standard Deviation 3.8 |
| Placebo | Carbon Dioxide Total | Day 3 | 25.3 mmol/L | Standard Deviation 2.8 |
| Placebo | Carbon Dioxide Total | Day 10 | 25.4 mmol/L | Standard Deviation 3.1 |
| Placebo | Carbon Dioxide Total | Day 7 | 26.3 mmol/L | Standard Deviation 2.8 |
| Placebo | Carbon Dioxide Total | Day 0 | 25.3 mmol/L | Standard Deviation 4.4 |
| Placebo | Carbon Dioxide Total | Screening | 25.4 mmol/L | Standard Deviation 3.1 |
CD4+/CD8+ Ratio
Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood
Time frame: Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | CD4+/CD8+ Ratio | Day 0 | 2.5 Ratio | Standard Deviation 1.7 |
| HB-adMSCs | CD4+/CD8+ Ratio | Day 7 | 2.4 Ratio | Standard Deviation 1.4 |
| HB-adMSCs | CD4+/CD8+ Ratio | Day 3 | 2.5 Ratio | Standard Deviation 1.3 |
| HB-adMSCs | CD4+/CD8+ Ratio | Day 10 | 2.4 Ratio | Standard Deviation 0.9 |
| Placebo | CD4+/CD8+ Ratio | Day 10 | 2.3 Ratio | Standard Deviation 1.3 |
| Placebo | CD4+/CD8+ Ratio | Day 0 | 1.9 Ratio | Standard Deviation 0.9 |
| Placebo | CD4+/CD8+ Ratio | Day 3 | 2.6 Ratio | Standard Deviation 1.7 |
| Placebo | CD4+/CD8+ Ratio | Day 7 | 2.4 Ratio | Standard Deviation 1.4 |
Chest X-Ray Score
Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Time frame: Day 0, Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Chest X-Ray Score | Day 0 | 2.9 Score on a Scale 0-25 | Standard Deviation 1.6 |
| HB-adMSCs | Chest X-Ray Score | Day 28 | 1.7 Score on a Scale 0-25 | Standard Deviation 1.6 |
| Placebo | Chest X-Ray Score | Day 0 | 2.7 Score on a Scale 0-25 | Standard Deviation 0.6 |
| Placebo | Chest X-Ray Score | Day 28 | 1.5 Score on a Scale 0-25 | Standard Deviation 2.1 |
Chloride
Clinical lab evaluation of level of Chloride in the blood (mmol/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Chloride | Day 0 | 103.3 mmol/L | Standard Deviation 3.7 |
| HB-adMSCs | Chloride | Day 7 | 102.5 mmol/L | Standard Deviation 5.5 |
| HB-adMSCs | Chloride | Day 3 | 103.3 mmol/L | Standard Deviation 4.2 |
| HB-adMSCs | Chloride | Day 10 | 101.9 mmol/L | Standard Deviation 4.6 |
| HB-adMSCs | Chloride | Screening | 103.0 mmol/L | Standard Deviation 3.9 |
| Placebo | Chloride | Day 10 | 104.1 mmol/L | Standard Deviation 1.4 |
| Placebo | Chloride | Screening | 102.2 mmol/L | Standard Deviation 2.9 |
| Placebo | Chloride | Day 0 | 101.0 mmol/L | Standard Deviation 4.4 |
| Placebo | Chloride | Day 3 | 101.8 mmol/L | Standard Deviation 4.1 |
| Placebo | Chloride | Day 7 | 102.1 mmol/L | Standard Deviation 2.1 |
Computed Tomography (CT) Score
Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, \< 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, \> 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Time frame: Day 0 and Day 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Computed Tomography (CT) Score | Day 0 | 2.9 Score on a Scale 0-25 | Standard Deviation 1.4 |
| HB-adMSCs | Computed Tomography (CT) Score | Day 28 | 1.2 Score on a Scale 0-25 | Standard Deviation 1.6 |
| Placebo | Computed Tomography (CT) Score | Day 0 | 3.0 Score on a Scale 0-25 | Standard Deviation 0.9 |
| Placebo | Computed Tomography (CT) Score | Day 28 | 1.2 Score on a Scale 0-25 | Standard Deviation 1.2 |
Creatinine Kinase MB (CK-MB)
Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)
Time frame: Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 19 at Day 0 and in Placebo group maximum number analyzed was 8 at Day 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Creatinine Kinase MB (CK-MB) | Day 0 | 2.6 ng/mL | Standard Deviation 2.6 |
| HB-adMSCs | Creatinine Kinase MB (CK-MB) | Day 3 | 3.0 ng/mL | Standard Deviation 4.6 |
| HB-adMSCs | Creatinine Kinase MB (CK-MB) | Day 7 | 3.3 ng/mL | Standard Deviation 2.9 |
| HB-adMSCs | Creatinine Kinase MB (CK-MB) | Day 10 | 3.7 ng/mL | Standard Deviation 3.9 |
| Placebo | Creatinine Kinase MB (CK-MB) | Day 10 | 1.9 ng/mL | — |
| Placebo | Creatinine Kinase MB (CK-MB) | Day 0 | 2.0 ng/mL | Standard Deviation 1.1 |
| Placebo | Creatinine Kinase MB (CK-MB) | Day 7 | 2.3 ng/mL | Standard Deviation 1.4 |
| Placebo | Creatinine Kinase MB (CK-MB) | Day 3 | 2.2 ng/mL | Standard Deviation 1.2 |
D-dimer
Change from baseline in D-dimer in the blood (mg/L)
Time frame: Day 0, 3, 7, and Day 10
Population: We had 24 participants in the treatment group and 9 in the placebo who had D-dimer values available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | D-dimer | Day 7 | 0.7 mg/L | Standard Deviation 0.5 |
| HB-adMSCs | D-dimer | Day 3 | 1.2 mg/L | Standard Deviation 1.7 |
| HB-adMSCs | D-dimer | Day 10 | 6.8 mg/L | Standard Deviation 7.7 |
| HB-adMSCs | D-dimer | Day 0 | 1.3 mg/L | Standard Deviation 1.4 |
| Placebo | D-dimer | Day 3 | 2.3 mg/L | Standard Deviation 2.8 |
| Placebo | D-dimer | Day 0 | 2.1 mg/L | Standard Deviation 2.6 |
| Placebo | D-dimer | Day 7 | 13.6 mg/L | Standard Deviation 9.1 |
Eosinophils
Clinical lab evaluation of level of Eosinophils n the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Eosinophils | Day 3 | 0.2 % of Eosinophils | Standard Deviation 0.6 |
| HB-adMSCs | Eosinophils | Day 0 | 0.2 % of Eosinophils | Standard Deviation 0.5 |
| HB-adMSCs | Eosinophils | Day 7 | 2.5 % of Eosinophils | Standard Deviation 9.2 |
| HB-adMSCs | Eosinophils | Day 10 | 1.1 % of Eosinophils | Standard Deviation 1.4 |
| HB-adMSCs | Eosinophils | Screening | 1.1 % of Eosinophils | Standard Deviation 3.1 |
| Placebo | Eosinophils | Day 10 | 1.0 % of Eosinophils | Standard Deviation 1.1 |
| Placebo | Eosinophils | Screening | 0.1 % of Eosinophils | Standard Deviation 0.5 |
| Placebo | Eosinophils | Day 0 | 0.3 % of Eosinophils | Standard Deviation 0.5 |
| Placebo | Eosinophils | Day 3 | 0.8 % of Eosinophils | Standard Deviation 1.4 |
| Placebo | Eosinophils | Day 7 | 0.7 % of Eosinophils | Standard Deviation 1 |
Estimated Glomerular Filtration Rate (eGFR) if African American
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 7 at Day 0 and in Placebo group maximum number analyzed was 2 at Day 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 7 | 78.8 mL/min/1.73 | Standard Deviation 50.1 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 3 | 98.2 mL/min/1.73 | Standard Deviation 58.9 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 10 | 78.4 mL/min/1.73 | Standard Deviation 45.7 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if African American | Screening | 106.4 mL/min/1.73 | Standard Deviation 37.3 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 0 | 74.3 mL/min/1.73 | Standard Deviation 42.7 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 10 | 94.5 mL/min/1.73 | Standard Deviation 26.2 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 0 | 107.0 mL/min/1.73 | — |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 3 | 97.0 mL/min/1.73 | — |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if African American | Day 7 | 107.0 mL/min/1.73 | — |
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73)
Time frame: Screening, Day 0, 3, 7, and 10
Population: Estimated glomerular filtration rate (eGFR) if Non-African American
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 3 | 113.4 mL/min/1.73 | Standard Deviation 25.2 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 7 | 102.8 mL/min/1.73 | Standard Deviation 44.8 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 10 | 107.0 mL/min/1.73 | Standard Deviation 36 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Screening | 230.3 mL/min/1.73 | Standard Deviation 270.1 |
| HB-adMSCs | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 0 | 143.0 mL/min/1.73 | Standard Deviation 103.8 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 0 | 117.0 mL/min/1.73 | Standard Deviation 33.9 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Screening | 127.1 mL/min/1.73 | Standard Deviation 30.7 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 7 | 109.6 mL/min/1.73 | Standard Deviation 16.5 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 3 | 112.8 mL/min/1.73 | Standard Deviation 22.4 |
| Placebo | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Day 10 | 108.0 mL/min/1.73 | Standard Deviation 18 |
Globulin Total
Clinical lab evaluation of the total level of Globulin in the blood (g/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Globulin Total | Day 0 | 2.6 g/dL | Standard Deviation 0.5 |
| HB-adMSCs | Globulin Total | Day 7 | 2.5 g/dL | Standard Deviation 0.5 |
| HB-adMSCs | Globulin Total | Day 3 | 2.5 g/dL | Standard Deviation 0.5 |
| HB-adMSCs | Globulin Total | Day 10 | 2.6 g/dL | Standard Deviation 0.6 |
| HB-adMSCs | Globulin Total | Screening | 2.8 g/dL | Standard Deviation 0.6 |
| Placebo | Globulin Total | Day 10 | 2.3 g/dL | Standard Deviation 0.4 |
| Placebo | Globulin Total | Screening | 2.9 g/dL | Standard Deviation 0.5 |
| Placebo | Globulin Total | Day 0 | 2.6 g/dL | Standard Deviation 0.4 |
| Placebo | Globulin Total | Day 3 | 2.6 g/dL | Standard Deviation 0.5 |
| Placebo | Globulin Total | Day 7 | 2.6 g/dL | Standard Deviation 0.4 |
Glucose
Clinical lab evaluation of level of Glucose in the blood (mg/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Glucose | Day 0 | 153.4 mg/dL | Standard Deviation 89 |
| HB-adMSCs | Glucose | Day 7 | 175.7 mg/dL | Standard Deviation 106.4 |
| HB-adMSCs | Glucose | Day 3 | 148.2 mg/dL | Standard Deviation 74.8 |
| HB-adMSCs | Glucose | Day 10 | 166.9 mg/dL | Standard Deviation 110 |
| HB-adMSCs | Glucose | Screening | 139.3 mg/dL | Standard Deviation 58 |
| Placebo | Glucose | Day 10 | 129.8 mg/dL | Standard Deviation 74.4 |
| Placebo | Glucose | Screening | 148.1 mg/dL | Standard Deviation 55.4 |
| Placebo | Glucose | Day 0 | 165.4 mg/dL | Standard Deviation 52.5 |
| Placebo | Glucose | Day 3 | 145.6 mg/dL | Standard Deviation 58.7 |
| Placebo | Glucose | Day 7 | 165.7 mg/dL | Standard Deviation 37.5 |
Hematocrit
Clinical lab evaluation of level of Hematocrit in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Hematocrit | Day 0 | 37.3 % of RBCs | Standard Deviation 6.8 |
| HB-adMSCs | Hematocrit | Day 7 | 33.2 % of RBCs | Standard Deviation 6.3 |
| HB-adMSCs | Hematocrit | Day 3 | 36.0 % of RBCs | Standard Deviation 7.7 |
| HB-adMSCs | Hematocrit | Day 10 | 34.6 % of RBCs | Standard Deviation 8.3 |
| HB-adMSCs | Hematocrit | Screening | 37.3 % of RBCs | Standard Deviation 6.7 |
| Placebo | Hematocrit | Day 10 | 36.7 % of RBCs | Standard Deviation 4.5 |
| Placebo | Hematocrit | Screening | 39.5 % of RBCs | Standard Deviation 6.3 |
| Placebo | Hematocrit | Day 0 | 38.8 % of RBCs | Standard Deviation 8.7 |
| Placebo | Hematocrit | Day 3 | 38.0 % of RBCs | Standard Deviation 6.3 |
| Placebo | Hematocrit | Day 7 | 39.6 % of RBCs | Standard Deviation 7.8 |
Hemoglobin
Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Hemoglobin | Day 0 | 11.9 g/dL | Standard Deviation 2.5 |
| HB-adMSCs | Hemoglobin | Day 7 | 10.8 g/dL | Standard Deviation 2.2 |
| HB-adMSCs | Hemoglobin | Day 3 | 11.6 g/dL | Standard Deviation 2.7 |
| HB-adMSCs | Hemoglobin | Day 10 | 11.1 g/dL | Standard Deviation 2.8 |
| HB-adMSCs | Hemoglobin | Screening | 12.0 g/dL | Standard Deviation 2.5 |
| Placebo | Hemoglobin | Day 10 | 12.4 g/dL | Standard Deviation 1.7 |
| Placebo | Hemoglobin | Screening | 12.8 g/dL | Standard Deviation 2.3 |
| Placebo | Hemoglobin | Day 0 | 12.5 g/dL | Standard Deviation 3.1 |
| Placebo | Hemoglobin | Day 3 | 12.1 g/dL | Standard Deviation 2 |
| Placebo | Hemoglobin | Day 7 | 13.4 g/dL | Standard Deviation 2.8 |
Immature Granulocytes
Clinical lab evaluation of level of Immature Granulocytes in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening. These were the largest N for which data for was collected for Immature granulocytes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Immature Granulocytes | Day 10 | 0.6 % of Immature Granulocytes | Standard Deviation 0.5 |
| HB-adMSCs | Immature Granulocytes | Day 3 | 1.6 % of Immature Granulocytes | Standard Deviation 1.7 |
| HB-adMSCs | Immature Granulocytes | Day 7 | 1.0 % of Immature Granulocytes | Standard Deviation 0.8 |
| HB-adMSCs | Immature Granulocytes | Screening | 0.4 % of Immature Granulocytes | Standard Deviation 0.6 |
| HB-adMSCs | Immature Granulocytes | Day 0 | 1.0 % of Immature Granulocytes | Standard Deviation 1.1 |
| Placebo | Immature Granulocytes | Screening | 1.2 % of Immature Granulocytes | Standard Deviation 1.1 |
| Placebo | Immature Granulocytes | Day 3 | 1.4 % of Immature Granulocytes | Standard Deviation 1.1 |
| Placebo | Immature Granulocytes | Day 0 | 1.8 % of Immature Granulocytes | Standard Deviation 1.5 |
International Normalized Ratio (INR)
Clinical lab evaluation of International Normalized Ratio (INR)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | International Normalized Ratio (INR) | Day 7 | 1.2 Ratio | Standard Deviation 0.4 |
| HB-adMSCs | International Normalized Ratio (INR) | Day 0 | 1.2 Ratio | Standard Deviation 0.3 |
| HB-adMSCs | International Normalized Ratio (INR) | Screening | 1.1 Ratio | Standard Deviation 0.1 |
| HB-adMSCs | International Normalized Ratio (INR) | Day 10 | 1.4 Ratio | Standard Deviation 0.6 |
| HB-adMSCs | International Normalized Ratio (INR) | Day 3 | 1.2 Ratio | Standard Deviation 0.3 |
| Placebo | International Normalized Ratio (INR) | Day 10 | 1.1 Ratio | Standard Deviation 0.2 |
| Placebo | International Normalized Ratio (INR) | Day 3 | 1.1 Ratio | Standard Deviation 0.1 |
| Placebo | International Normalized Ratio (INR) | Day 7 | 1.1 Ratio | Standard Deviation 0.1 |
| Placebo | International Normalized Ratio (INR) | Screening | 1.1 Ratio | Standard Deviation 0.1 |
| Placebo | International Normalized Ratio (INR) | Day 0 | 1.1 Ratio | Standard Deviation 0.1 |
Lymphocytes
Clinical lab evaluation of level of Lymphocytes in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Lymphocytes | Day 0 | 11.3 Percentage of Lymphocytes (%) | Standard Deviation 8.2 |
| HB-adMSCs | Lymphocytes | Day 7 | 17.4 Percentage of Lymphocytes (%) | Standard Deviation 13.3 |
| HB-adMSCs | Lymphocytes | Day 3 | 14.5 Percentage of Lymphocytes (%) | Standard Deviation 13.9 |
| HB-adMSCs | Lymphocytes | Day 10 | 17.0 Percentage of Lymphocytes (%) | Standard Deviation 11.8 |
| HB-adMSCs | Lymphocytes | Screening | 14.4 Percentage of Lymphocytes (%) | Standard Deviation 11.4 |
| Placebo | Lymphocytes | Day 10 | 25.7 Percentage of Lymphocytes (%) | Standard Deviation 14.2 |
| Placebo | Lymphocytes | Screening | 16.0 Percentage of Lymphocytes (%) | Standard Deviation 11.1 |
| Placebo | Lymphocytes | Day 0 | 12.1 Percentage of Lymphocytes (%) | Standard Deviation 7.9 |
| Placebo | Lymphocytes | Day 3 | 17.2 Percentage of Lymphocytes (%) | Standard Deviation 12.7 |
| Placebo | Lymphocytes | Day 7 | 16.8 Percentage of Lymphocytes (%) | Standard Deviation 13.5 |
Mean Corpuscular Hemoglobin Concentration (MCHC)
Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 0 | 31.9 g/dL | Standard Deviation 2 |
| HB-adMSCs | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 7 | 32.6 g/dL | Standard Deviation 2.1 |
| HB-adMSCs | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 3 | 32.1 g/dL | Standard Deviation 1.9 |
| HB-adMSCs | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 10 | 31.9 g/dL | Standard Deviation 2 |
| HB-adMSCs | Mean Corpuscular Hemoglobin Concentration (MCHC) | Screening | 32.0 g/dL | Standard Deviation 1.8 |
| Placebo | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 10 | 33.7 g/dL | Standard Deviation 0.8 |
| Placebo | Mean Corpuscular Hemoglobin Concentration (MCHC) | Screening | 32.3 g/dL | Standard Deviation 1.6 |
| Placebo | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 0 | 32.0 g/dL | Standard Deviation 1.8 |
| Placebo | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 3 | 31.8 g/dL | Standard Deviation 1.9 |
| Placebo | Mean Corpuscular Hemoglobin Concentration (MCHC) | Day 7 | 33.6 g/dL | Standard Deviation 1.2 |
Mean Corpuscular Hemoglobin (MCH)
Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Mean Corpuscular Hemoglobin (MCH) | Day 0 | 28.6 pg | Standard Deviation 3.8 |
| HB-adMSCs | Mean Corpuscular Hemoglobin (MCH) | Day 7 | 28.3 pg | Standard Deviation 3.9 |
| HB-adMSCs | Mean Corpuscular Hemoglobin (MCH) | Day 3 | 28.8 pg | Standard Deviation 3.9 |
| HB-adMSCs | Mean Corpuscular Hemoglobin (MCH) | Day 10 | 28.7 pg | Standard Deviation 3.1 |
| HB-adMSCs | Mean Corpuscular Hemoglobin (MCH) | Screening | 28.5 pg | Standard Deviation 3.9 |
| Placebo | Mean Corpuscular Hemoglobin (MCH) | Day 10 | 28.7 pg | Standard Deviation 1 |
| Placebo | Mean Corpuscular Hemoglobin (MCH) | Screening | 45.4 pg | Standard Deviation 67.6 |
| Placebo | Mean Corpuscular Hemoglobin (MCH) | Day 0 | 27.8 pg | Standard Deviation 2.5 |
| Placebo | Mean Corpuscular Hemoglobin (MCH) | Day 3 | 27.4 pg | Standard Deviation 2.9 |
| Placebo | Mean Corpuscular Hemoglobin (MCH) | Day 7 | 28.7 pg | Standard Deviation 1.5 |
Mean Corpuscular Volume (MCV)
Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Mean Corpuscular Volume (MCV) | Day 7 | 86.8 fL | Standard Deviation 9.5 |
| HB-adMSCs | Mean Corpuscular Volume (MCV) | Day 10 | 89.8 fL | Standard Deviation 8.7 |
| HB-adMSCs | Mean Corpuscular Volume (MCV) | Screening | 88.8 fL | Standard Deviation 9.7 |
| HB-adMSCs | Mean Corpuscular Volume (MCV) | Day 0 | 89.6 fL | Standard Deviation 8.9 |
| HB-adMSCs | Mean Corpuscular Volume (MCV) | Day 3 | 89.4 fL | Standard Deviation 9.8 |
| Placebo | Mean Corpuscular Volume (MCV) | Day 3 | 85.8 fL | Standard Deviation 6.2 |
| Placebo | Mean Corpuscular Volume (MCV) | Day 0 | 86.8 fL | Standard Deviation 6 |
| Placebo | Mean Corpuscular Volume (MCV) | Day 10 | 85.0 fL | Standard Deviation 1.9 |
| Placebo | Mean Corpuscular Volume (MCV) | Day 7 | 85.2 fL | Standard Deviation 3.2 |
| Placebo | Mean Corpuscular Volume (MCV) | Screening | 86.9 fL | Standard Deviation 4.4 |
Monocytes
Clinical lab evaluation of level of Monocytes in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Monocytes | Day 3 | 5.4 % of Monocytes | Standard Deviation 2.9 |
| HB-adMSCs | Monocytes | Day 7 | 5.4 % of Monocytes | Standard Deviation 3.1 |
| HB-adMSCs | Monocytes | Day 10 | 5.2 % of Monocytes | Standard Deviation 3.6 |
| HB-adMSCs | Monocytes | Screening | 5.7 % of Monocytes | Standard Deviation 3.3 |
| HB-adMSCs | Monocytes | Day 0 | 5.4 % of Monocytes | Standard Deviation 3.6 |
| Placebo | Monocytes | Day 0 | 4.9 % of Monocytes | Standard Deviation 2.2 |
| Placebo | Monocytes | Screening | 5.4 % of Monocytes | Standard Deviation 2.7 |
| Placebo | Monocytes | Day 7 | 5.5 % of Monocytes | Standard Deviation 4.8 |
| Placebo | Monocytes | Day 3 | 5.8 % of Monocytes | Standard Deviation 4 |
| Placebo | Monocytes | Day 10 | 6.5 % of Monocytes | Standard Deviation 3.8 |
Myoglobin
Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)
Time frame: Day 0, 3 7, and 10
Population: In the treatment arm, maximum number analyzed was 3 at Day 3 and in Placebo group maximum number analyzed was 1 at Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Myoglobin | Day 3 | 142.3 ng/mL | Standard Deviation 155.8 |
| HB-adMSCs | Myoglobin | Day 7 | 21.5 ng/mL | Standard Deviation 0.7 |
| HB-adMSCs | Myoglobin | Day 0 | 183.0 ng/mL | — |
| HB-adMSCs | Myoglobin | Day 10 | 50.3 ng/mL | Standard Deviation 48.2 |
| Placebo | Myoglobin | Day 0 | 21.0 ng/mL | — |
| Placebo | Myoglobin | Day 3 | 100.0 ng/mL | — |
Neutrophils
Clinical lab evaluation of level of Neutrophils in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Neutrophils | Day 0 | 79.4 % of Neutrophils | Standard Deviation 15.4 |
| HB-adMSCs | Neutrophils | Day 7 | 73.5 % of Neutrophils | Standard Deviation 15.6 |
| HB-adMSCs | Neutrophils | Day 3 | 77.0 % of Neutrophils | Standard Deviation 15.3 |
| HB-adMSCs | Neutrophils | Day 10 | 75.1 % of Neutrophils | Standard Deviation 13.3 |
| HB-adMSCs | Neutrophils | Screening | 78.3 % of Neutrophils | Standard Deviation 14.6 |
| Placebo | Neutrophils | Day 10 | 66.2 % of Neutrophils | Standard Deviation 17.2 |
| Placebo | Neutrophils | Screening | 75.8 % of Neutrophils | Standard Deviation 16.1 |
| Placebo | Neutrophils | Day 0 | 80.7 % of Neutrophils | Standard Deviation 11.3 |
| Placebo | Neutrophils | Day 3 | 75.3 % of Neutrophils | Standard Deviation 15.9 |
| Placebo | Neutrophils | Day 7 | 75.7 % of Neutrophils | Standard Deviation 16.6 |
NK Cell Surface Antigen (CD3-CD56+)
Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)
Time frame: Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 6 at Day 0 and in Placebo group maximum number analyzed was 1 at Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | NK Cell Surface Antigen (CD3-CD56+) | Day 0 | 66.4 % of Cells | Standard Deviation 58.5 |
| HB-adMSCs | NK Cell Surface Antigen (CD3-CD56+) | Day 7 | 21.9 % of Cells | Standard Deviation 30.3 |
| Placebo | NK Cell Surface Antigen (CD3-CD56+) | Day 0 | 6.9 % of Cells | — |
| Placebo | NK Cell Surface Antigen (CD3-CD56+) | Day 3 | 320.0 % of Cells | — |
Partial Thromboplastin Time (PTT)
Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)
Time frame: Screening, Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 25 at screening and in Placebo group maximum number analyzed was11 at screening. These were the largest N for which data for was collected for Partial Thromboplastin time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Partial Thromboplastin Time (PTT) | Day 0 | 31.6 seconds | Standard Deviation 6.6 |
| HB-adMSCs | Partial Thromboplastin Time (PTT) | Screening | 32.0 seconds | Standard Deviation 5.5 |
| HB-adMSCs | Partial Thromboplastin Time (PTT) | Day 3 | 32.2 seconds | Standard Deviation 5.8 |
| HB-adMSCs | Partial Thromboplastin Time (PTT) | Day 7 | 31.0 seconds | Standard Deviation 6.9 |
| HB-adMSCs | Partial Thromboplastin Time (PTT) | Day 10 | 24.5 seconds | Standard Deviation 12.7 |
| Placebo | Partial Thromboplastin Time (PTT) | Day 0 | 29.8 seconds | Standard Deviation 4.2 |
| Placebo | Partial Thromboplastin Time (PTT) | Day 3 | 26.5 seconds | Standard Deviation 6.4 |
| Placebo | Partial Thromboplastin Time (PTT) | Screening | 30.4 seconds | Standard Deviation 3.8 |
| Placebo | Partial Thromboplastin Time (PTT) | Day 10 | 28.2 seconds | Standard Deviation 1.4 |
Platelets
Clinical lab evaluation of level of Platelets in the blood (cells x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Platelets | Day 7 | 273.1 cells x 10^3/uL | Standard Deviation 119.6 |
| HB-adMSCs | Platelets | Day 10 | 245.2 cells x 10^3/uL | Standard Deviation 110.5 |
| HB-adMSCs | Platelets | Screening | 232.4 cells x 10^3/uL | Standard Deviation 102.9 |
| HB-adMSCs | Platelets | Day 0 | 237.5 cells x 10^3/uL | Standard Deviation 98.8 |
| HB-adMSCs | Platelets | Day 3 | 258.2 cells x 10^3/uL | Standard Deviation 115.7 |
| Placebo | Platelets | Day 3 | 295.8 cells x 10^3/uL | Standard Deviation 109 |
| Placebo | Platelets | Day 0 | 304.8 cells x 10^3/uL | Standard Deviation 101.1 |
| Placebo | Platelets | Day 10 | 303.8 cells x 10^3/uL | Standard Deviation 86.5 |
| Placebo | Platelets | Day 7 | 323.1 cells x 10^3/uL | Standard Deviation 101.2 |
| Placebo | Platelets | Screening | 282.1 cells x 10^3/uL | Standard Deviation 122.8 |
Potassium
Clinical lab evaluation of level of Potassium in the blood (mmol/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Potassium | Day 0 | 4.1 mmol/L | Standard Deviation 0.5 |
| HB-adMSCs | Potassium | Day 7 | 4.3 mmol/L | Standard Deviation 1.3 |
| HB-adMSCs | Potassium | Day 3 | 3.9 mmol/L | Standard Deviation 0.6 |
| HB-adMSCs | Potassium | Day 10 | 4.5 mmol/L | Standard Deviation 1 |
| HB-adMSCs | Potassium | Screening | 4.2 mmol/L | Standard Deviation 0.5 |
| Placebo | Potassium | Day 10 | 4.2 mmol/L | Standard Deviation 0.5 |
| Placebo | Potassium | Screening | 4.2 mmol/L | Standard Deviation 0.5 |
| Placebo | Potassium | Day 0 | 4.1 mmol/L | Standard Deviation 0.6 |
| Placebo | Potassium | Day 3 | 4.0 mmol/L | Standard Deviation 0.3 |
| Placebo | Potassium | Day 7 | 4.5 mmol/L | Standard Deviation 0.5 |
Protein Total
Clinical lab evaluation of total level of Protein in the blood (g/dL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Protein Total | Day 0 | 5.9 g/dL | Standard Deviation 0.7 |
| HB-adMSCs | Protein Total | Day 7 | 5.6 g/dL | Standard Deviation 1.1 |
| HB-adMSCs | Protein Total | Day 3 | 5.7 g/dL | Standard Deviation 0.8 |
| HB-adMSCs | Protein Total | Day 10 | 6.0 g/dL | Standard Deviation 1.1 |
| HB-adMSCs | Protein Total | Screening | 6.2 g/dL | Standard Deviation 0.9 |
| Placebo | Protein Total | Day 10 | 6.3 g/dL | Standard Deviation 0.4 |
| Placebo | Protein Total | Screening | 6.5 g/dL | Standard Deviation 0.8 |
| Placebo | Protein Total | Day 0 | 6.0 g/dL | Standard Deviation 0.8 |
| Placebo | Protein Total | Day 3 | 6.0 g/dL | Standard Deviation 0.7 |
| Placebo | Protein Total | Day 7 | 6.1 g/dL | Standard Deviation 0.6 |
Prothrombin Time (PT)
Clinical lab evaluation of Prothrombin Time (seconds)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Prothrombin Time (PT) | Screening | 11.5 seconds | Standard Deviation 1.2 |
| HB-adMSCs | Prothrombin Time (PT) | Day 3 | 14.4 seconds | Standard Deviation 3.1 |
| HB-adMSCs | Prothrombin Time (PT) | Day 10 | 16.1 seconds | Standard Deviation 5.8 |
| HB-adMSCs | Prothrombin Time (PT) | Day 7 | 15.3 seconds | Standard Deviation 4.1 |
| HB-adMSCs | Prothrombin Time (PT) | Day 0 | 14.3 seconds | Standard Deviation 3.9 |
| Placebo | Prothrombin Time (PT) | Day 10 | 14.3 seconds | Standard Deviation 1.7 |
| Placebo | Prothrombin Time (PT) | Screening | 12.0 seconds | Standard Deviation 1.4 |
| Placebo | Prothrombin Time (PT) | Day 0 | 12.9 seconds | Standard Deviation 2 |
| Placebo | Prothrombin Time (PT) | Day 3 | 13.9 seconds | Standard Deviation 2 |
| Placebo | Prothrombin Time (PT) | Day 7 | 14.6 seconds | Standard Deviation 1.4 |
Red Blood Cell (RBC) Count
Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Red Blood Cell (RBC) Count | Day 0 | 4.2 cells x 10^3/uL | Standard Deviation 0.8 |
| HB-adMSCs | Red Blood Cell (RBC) Count | Day 7 | 3.9 cells x 10^3/uL | Standard Deviation 0.8 |
| HB-adMSCs | Red Blood Cell (RBC) Count | Day 3 | 4.1 cells x 10^3/uL | Standard Deviation 0.9 |
| HB-adMSCs | Red Blood Cell (RBC) Count | Day 10 | 3.9 cells x 10^3/uL | Standard Deviation 0.9 |
| HB-adMSCs | Red Blood Cell (RBC) Count | Screening | 4.2 cells x 10^3/uL | Standard Deviation 0.7 |
| Placebo | Red Blood Cell (RBC) Count | Day 10 | 4.3 cells x 10^3/uL | Standard Deviation 0.5 |
| Placebo | Red Blood Cell (RBC) Count | Screening | 4.5 cells x 10^3/uL | Standard Deviation 0.6 |
| Placebo | Red Blood Cell (RBC) Count | Day 0 | 4.5 cells x 10^3/uL | Standard Deviation 1 |
| Placebo | Red Blood Cell (RBC) Count | Day 3 | 4.5 cells x 10^3/uL | Standard Deviation 1 |
| Placebo | Red Blood Cell (RBC) Count | Day 7 | 4.6 cells x 10^3/uL | Standard Deviation 0.8 |
Red Cell Distribution Width (RDW)
Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Red Cell Distribution Width (RDW) | Day 0 | 18.8 Red Cell Distribution Width % | Standard Deviation 23.5 |
| HB-adMSCs | Red Cell Distribution Width (RDW) | Day 7 | 15.5 Red Cell Distribution Width % | Standard Deviation 4.5 |
| HB-adMSCs | Red Cell Distribution Width (RDW) | Day 3 | 15.3 Red Cell Distribution Width % | Standard Deviation 4.8 |
| HB-adMSCs | Red Cell Distribution Width (RDW) | Day 10 | 14.9 Red Cell Distribution Width % | Standard Deviation 2.1 |
| HB-adMSCs | Red Cell Distribution Width (RDW) | Screening | 14.4 Red Cell Distribution Width % | Standard Deviation 1.9 |
| Placebo | Red Cell Distribution Width (RDW) | Day 10 | 14.3 Red Cell Distribution Width % | Standard Deviation 1.2 |
| Placebo | Red Cell Distribution Width (RDW) | Screening | 13.9 Red Cell Distribution Width % | Standard Deviation 1.4 |
| Placebo | Red Cell Distribution Width (RDW) | Day 0 | 14.1 Red Cell Distribution Width % | Standard Deviation 1.5 |
| Placebo | Red Cell Distribution Width (RDW) | Day 3 | 14.3 Red Cell Distribution Width % | Standard Deviation 2.1 |
| Placebo | Red Cell Distribution Width (RDW) | Day 7 | 13.7 Red Cell Distribution Width % | Standard Deviation 0.9 |
Serum Ferritin
Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)
Time frame: Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 24 at Day 0 and in Placebo group maximum number analyzed was 7 at Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Serum Ferritin | Day 7 | 753.9 ng/mL | Standard Deviation 449.4 |
| HB-adMSCs | Serum Ferritin | Day 10 | 509.0 ng/mL | Standard Deviation 384.9 |
| HB-adMSCs | Serum Ferritin | Day 0 | 420.5 ng/mL | Standard Deviation 406 |
| HB-adMSCs | Serum Ferritin | Day 3 | 499.6 ng/mL | Standard Deviation 424.2 |
| Placebo | Serum Ferritin | Day 3 | 391.2 ng/mL | Standard Deviation 324 |
| Placebo | Serum Ferritin | Day 7 | 361.0 ng/mL | Standard Deviation 397.8 |
| Placebo | Serum Ferritin | Day 0 | 423.5 ng/mL | Standard Deviation 387.9 |
| Placebo | Serum Ferritin | Day 10 | 63.2 ng/mL | — |
Sodium
Clinical lab evaluation of level of Sodium in the blood (mmol/L)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Sodium | Day 0 | 139.4 mmol/L | Standard Deviation 3.6 |
| HB-adMSCs | Sodium | Day 7 | 132.3 mmol/L | Standard Deviation 29.6 |
| HB-adMSCs | Sodium | Day 3 | 140.6 mmol/L | Standard Deviation 3.3 |
| HB-adMSCs | Sodium | Day 10 | 139.2 mmol/L | Standard Deviation 4.4 |
| HB-adMSCs | Sodium | Screening | 137.8 mmol/L | Standard Deviation 3.5 |
| Placebo | Sodium | Day 10 | 141.2 mmol/L | Standard Deviation 1.9 |
| Placebo | Sodium | Screening | 136.9 mmol/L | Standard Deviation 3.5 |
| Placebo | Sodium | Day 0 | 137.9 mmol/L | Standard Deviation 3.5 |
| Placebo | Sodium | Day 3 | 140.0 mmol/L | Standard Deviation 2.8 |
| Placebo | Sodium | Day 7 | 139.3 mmol/L | Standard Deviation 3.2 |
Troponin
Clinical lab evaluation of level of Troponin in the blood (ng/mL)
Time frame: Day 0, 3, 7, and 10
Population: In the treatment arm, maximum number analyzed was 14 at Day 0 and in Placebo group maximum number analyzed was 5 at Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | Troponin | Day 3 | 0.0 ng/mL | Standard Deviation 0 |
| HB-adMSCs | Troponin | Day 0 | 0.5 ng/mL | Standard Deviation 1.8 |
| HB-adMSCs | Troponin | Day 7 | 0.1 ng/mL | Standard Deviation 0.2 |
| HB-adMSCs | Troponin | Day 10 | 0.0 ng/mL | Standard Deviation 0 |
| Placebo | Troponin | Day 3 | 0.0 ng/mL | — |
| Placebo | Troponin | Day 0 | 0.0 ng/mL | Standard Deviation 0 |
| Placebo | Troponin | Day 7 | 0.0 ng/mL | — |
White Blood Count (WBC)
Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10\^3/uL)
Time frame: Screening, Day 0, 3, 7, and 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HB-adMSCs | White Blood Count (WBC) | Day 0 | 11.3 cells x 10^3/uL | Standard Deviation 10.5 |
| HB-adMSCs | White Blood Count (WBC) | Day 7 | 12.1 cells x 10^3/uL | Standard Deviation 5.8 |
| HB-adMSCs | White Blood Count (WBC) | Day 3 | 13.5 cells x 10^3/uL | Standard Deviation 11.3 |
| HB-adMSCs | White Blood Count (WBC) | Day 10 | 10.4 cells x 10^3/uL | Standard Deviation 5 |
| HB-adMSCs | White Blood Count (WBC) | Screening | 8.4 cells x 10^3/uL | Standard Deviation 4 |
| Placebo | White Blood Count (WBC) | Day 10 | 11.4 cells x 10^3/uL | Standard Deviation 5.8 |
| Placebo | White Blood Count (WBC) | Screening | 8.6 cells x 10^3/uL | Standard Deviation 5 |
| Placebo | White Blood Count (WBC) | Day 0 | 10.3 cells x 10^3/uL | Standard Deviation 3.6 |
| Placebo | White Blood Count (WBC) | Day 3 | 13.8 cells x 10^3/uL | Standard Deviation 8.7 |
| Placebo | White Blood Count (WBC) | Day 7 | 12.7 cells x 10^3/uL | Standard Deviation 5.5 |