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Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04362189
Enrollment
48
Registered
2020-04-24
Start date
2020-06-30
Completion date
2021-09-30
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

BIOLOGICALHB-adMSC

Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

OTHERPlacebo

Saline

Sponsors

River Oaks Hospital and Clinics
CollaboratorOTHER
United Memorial Medical Center
CollaboratorOTHER
Hope Biosciences Research Foundation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Return To Room Air (RTRA)Day 0, 3, 7, and 10Number of participants who returned to room air
Tumor Necrosis Factor-Alpha (TNF-alpha)Day 0, 3, 7, and 10Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Interleukin-10 (IL-10)Day 0, 3, 7, and 10Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)
Interleukin-6 (IL-6)Day 0, 3, 7, and 10Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)
C-Reactive Protein (CRP)Day 0, 3, 7, and 10Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)
OxygenationDay 0, 3, 7, and 10Change from baseline Oxygenation (%) in the blood

Secondary

MeasureTime frameDescription
CD4+/CD8+ RatioDay 0, 3, 7, and 10Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood
7-Point Ordinal ScaleDay 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) ScoreDay 0 and Day 28Change 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 ScoreDay 0, Day 28Change 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.
GlucoseScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Glucose in the blood (mg/dL)
Blood Urea Nitrogen (BUN)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)
Estimated Glomerular Filtration Rate (eGFR) if Non-African AmericanScreening, Day 0, 3, 7, and 10Clinical 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 AmericanScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)
BUN/Creatinine RatioScreening, Day 0, 3, 7, and 10Clinical lab evaluation of BUN/Creatinine Ratio in the blood
SodiumScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Sodium in the blood (mmol/L)
PotassiumScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Potassium in the blood (mmol/L)
ChlorideScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Chloride in the blood (mmol/L)
Carbon Dioxide TotalScreening, Day 0, 3, 7, and 10Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)
CalciumScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Calcium in the blood (mg/dL)
Protein TotalScreening, Day 0, 3, 7, and 10Clinical lab evaluation of total level of Protein in the blood (g/dL)
AlbuminScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Albumin in the blood (g/dL)
Globulin TotalScreening, Day 0, 3, 7, and 10Clinical lab evaluation of the total level of Globulin in the blood (g/dL)
Albumin/Globulin (A/G) RatioScreening, Day 0, 3, 7, and 10Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood
Bilirubin TotalScreening, Day 0, 3, 7, and 10Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)
Alkaline PhosphataseScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)
Aspartate Aminotransferase (SGOT)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)
Alanine Aminotransferase (SGPT)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)
White Blood Count (WBC)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10\^3/uL)
Red Blood Cell (RBC) CountScreening, Day 0, 3, 7, and 10Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10\^3/uL)
HemoglobinScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)
HematocritScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Hematocrit in the blood (%)
Mean Corpuscular Volume (MCV)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)
Mean Corpuscular Hemoglobin (MCH)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)
Mean Corpuscular Hemoglobin Concentration (MCHC)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)
Red Cell Distribution Width (RDW)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)
PlateletsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Platelets in the blood (cells x10\^3/uL)
NeutrophilsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Neutrophils in the blood (%)
LymphocytesScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Lymphocytes in the blood (%)
MonocytesScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Monocytes in the blood (%)
EosinophilsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Eosinophils n the blood (%)
BasophilsScreening, Day 0, 3, 7 and 10Clinical lab evaluation of level of Basophils in the blood (%)
Absolute NeutrophilsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10\^3/uL)
Absolute LymphocytesScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10\^3/uL)
Absolute MonocytesScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10\^3/uL)
Absolute EosinophilsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10\^3/uL)
Absolute BasophilsScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10\^3/uL)
Immature GranulocytesScreening, Day 0, 3, 7, and 10Clinical lab evaluation of level of Immature Granulocytes in the blood (%)
Absolute Immature GranulocytesScreening, Day 0, 3, 7, and 10Clinical 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 10Clinical lab evaluation of International Normalized Ratio (INR)
D-dimerDay 0, 3, 7, and Day 10Change from baseline in D-dimer in the blood (mg/L)
Partial Thromboplastin Time (PTT)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)
Prothrombin Time (PT)Screening, Day 0, 3, 7, and 10Clinical lab evaluation of Prothrombin Time (seconds)
MyoglobinDay 0, 3 7, and 10Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)
TroponinDay 0, 3, 7, and 10Clinical lab evaluation of level of Troponin in the blood (ng/mL)
Creatinine Kinase MB (CK-MB)Day 0, 3, 7, and 10Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)
Serum FerritinDay 0, 3, 7, and 10Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)
NK Cell Surface Antigen (CD3-CD56+)Day 0, 3, 7, and 10Clinical 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

ArmCount
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
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event02
Overall StudyDeath41
Overall StudyDischarge or Transfer to other Hospital30
Overall StudyFDA Clinical Hold72
Overall StudyLost to Follow-up01
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicHB-adMSCsPlaceboTotal
Age, Continuous53.2 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 Participants9 Participants22 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants6 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Height66.5 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
11 Participants3 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
21 Participants11 Participants32 Participants
Sex: Female, Male
Female
15 Participants5 Participants20 Participants
Sex: Female, Male
Male
18 Participants10 Participants28 Participants
Weight194.6 lbs
STANDARD_DEVIATION 48.2
194.1 lbs
STANDARD_DEVIATION 43.7
194.4 lbs
STANDARD_DEVIATION 46.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8 / 332 / 15
other
Total, other adverse events
27 / 3312 / 15
serious
Total, serious adverse events
9 / 332 / 15

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsC-Reactive Protein (CRP)Day 0 (Baseline)4.9 mg/LStandard Deviation 5.8
HB-adMSCsC-Reactive Protein (CRP)Day 34.8 mg/LStandard Deviation 7.5
HB-adMSCsC-Reactive Protein (CRP)Day 73.6 mg/LStandard Deviation 3.4
HB-adMSCsC-Reactive Protein (CRP)Day 103.5 mg/LStandard Deviation 4.8
PlaceboC-Reactive Protein (CRP)Day 100.2 mg/LStandard Deviation 0.2
PlaceboC-Reactive Protein (CRP)Day 0 (Baseline)3.8 mg/LStandard Deviation 5.1
PlaceboC-Reactive Protein (CRP)Day 72.2 mg/LStandard Deviation 4.1
PlaceboC-Reactive Protein (CRP)Day 34.5 mg/LStandard Deviation 9.2
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsInterleukin-10 (IL-10)Day 0 (Baseline)16.3 pg/mLStandard Deviation 19.4
HB-adMSCsInterleukin-10 (IL-10)Day 318.8 pg/mLStandard Deviation 39.1
HB-adMSCsInterleukin-10 (IL-10)Day 730.8 pg/mLStandard Deviation 86.3
HB-adMSCsInterleukin-10 (IL-10)Day 1013.0 pg/mLStandard Deviation 13.5
PlaceboInterleukin-10 (IL-10)Day 108.4 pg/mLStandard Deviation 10.8
PlaceboInterleukin-10 (IL-10)Day 0 (Baseline)11.9 pg/mLStandard Deviation 16.6
PlaceboInterleukin-10 (IL-10)Day 727.2 pg/mLStandard Deviation 65.1
PlaceboInterleukin-10 (IL-10)Day 344.7 pg/mLStandard Deviation 98.9
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsInterleukin-6 (IL-6)Day 0 (Baseline)24.3 pg/mLStandard Deviation 71.8
HB-adMSCsInterleukin-6 (IL-6)Day 346.3 pg/mLStandard Deviation 104
HB-adMSCsInterleukin-6 (IL-6)Day 765.4 pg/mLStandard Deviation 186.8
HB-adMSCsInterleukin-6 (IL-6)Day 1035.0 pg/mLStandard Deviation 70.4
PlaceboInterleukin-6 (IL-6)Day 1012.4 pg/mLStandard Deviation 23.9
PlaceboInterleukin-6 (IL-6)Day 0 (Baseline)69.4 pg/mLStandard Deviation 166.5
PlaceboInterleukin-6 (IL-6)Day 7197.8 pg/mLStandard Deviation 539.7
PlaceboInterleukin-6 (IL-6)Day 3376.6 pg/mLStandard Deviation 988.7
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Primary

Oxygenation

Change from baseline Oxygenation (%) in the blood

Time frame: Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsOxygenationDay 0 (Baseline)95.3 % of Oxygen SaturationStandard Deviation 3.1
HB-adMSCsOxygenationDay 796.2 % of Oxygen SaturationStandard Deviation 2.2
HB-adMSCsOxygenationDay 395.4 % of Oxygen SaturationStandard Deviation 3.2
HB-adMSCsOxygenationDay 1096.7 % of Oxygen SaturationStandard Deviation 2.5
PlaceboOxygenationDay 394.5 % of Oxygen SaturationStandard Deviation 4.7
PlaceboOxygenationDay 0 (Baseline)89.4 % of Oxygen SaturationStandard Deviation 19.1
PlaceboOxygenationDay 1096.7 % of Oxygen SaturationStandard Deviation 1.7
PlaceboOxygenationDay 795.8 % of Oxygen SaturationStandard Deviation 5.7
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Primary

Return To Room Air (RTRA)

Number of participants who returned to room air

Time frame: Day 0, 3, 7, and 10

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HB-adMSCsReturn To Room Air (RTRA)Day 015 Participants
HB-adMSCsReturn To Room Air (RTRA)Day 313 Participants
HB-adMSCsReturn To Room Air (RTRA)Day 711 Participants
HB-adMSCsReturn To Room Air (RTRA)Day 1012 Participants
PlaceboReturn To Room Air (RTRA)Day 108 Participants
PlaceboReturn To Room Air (RTRA)Day 04 Participants
PlaceboReturn To Room Air (RTRA)Day 77 Participants
PlaceboReturn To Room Air (RTRA)Day 38 Participants
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsTumor Necrosis Factor-Alpha (TNF-alpha)Day 1020.3 pg/mLStandard Deviation 11.3
HB-adMSCsTumor Necrosis Factor-Alpha (TNF-alpha)Day 326.1 pg/mLStandard Deviation 26.5
HB-adMSCsTumor Necrosis Factor-Alpha (TNF-alpha)Day 733.4 pg/mLStandard Deviation 49.8
HB-adMSCsTumor Necrosis Factor-Alpha (TNF-alpha)Day 0 (Baseline)15.5 pg/mLStandard Deviation 13.9
PlaceboTumor Necrosis Factor-Alpha (TNF-alpha)Day 1030.5 pg/mLStandard Deviation 40.5
PlaceboTumor Necrosis Factor-Alpha (TNF-alpha)Day 0 (Baseline)18.2 pg/mLStandard Deviation 12.3
PlaceboTumor Necrosis Factor-Alpha (TNF-alpha)Day 315.9 pg/mLStandard Deviation 10
PlaceboTumor Necrosis Factor-Alpha (TNF-alpha)Day 735.3 pg/mLStandard Deviation 38.8
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Secondary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HB-adMSCs7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 28 (End of Study)9 Participants
HB-adMSCs7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 104 Participants
HB-adMSCs7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 02 Participants
HB-adMSCs7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study)1 Participants
HB-adMSCs7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 08 Participants
HB-adMSCs7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 06 Participants
HB-adMSCs7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 106 Participants
HB-adMSCs7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 34 Participants
HB-adMSCs7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 33 Participants
HB-adMSCs7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 75 Participants
HB-adMSCs7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 39 Participants
HB-adMSCs7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 102 Participants
HB-adMSCs7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 72 Participants
HB-adMSCs7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study)0 Participants
HB-adMSCs7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 73 Participants
HB-adMSCs7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 01 Participants
HB-adMSCs7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 101 Participants
HB-adMSCs7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 31 Participants
HB-adMSCs7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 714 Participants
HB-adMSCs7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 70 Participants
HB-adMSCs7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study)0 Participants
HB-adMSCs7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 102 Participants
HB-adMSCs7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 28 (End of Study)14 Participants
HB-adMSCs7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study)1 Participants
HB-adMSCs7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 015 Participants
HB-adMSCs7-Point Ordinal Scale7: Death - Day 00 Participants
HB-adMSCs7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 1012 Participants
HB-adMSCs7-Point Ordinal Scale7: Death - Day 31 Participants
HB-adMSCs7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 312 Participants
HB-adMSCs7-Point Ordinal Scale7: Death - Day 74 Participants
HB-adMSCs7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 33 Participants
HB-adMSCs7-Point Ordinal Scale7: Death - Day 106 Participants
HB-adMSCs7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 75 Participants
HB-adMSCs7-Point Ordinal Scale7: Death - Day 28 (End of Study)8 Participants
HB-adMSCs7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 01 Participants
Placebo7-Point Ordinal Scale7: Death - Day 28 (End of Study)2 Participants
Placebo7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 01 Participants
Placebo7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 33 Participants
Placebo7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 75 Participants
Placebo7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 105 Participants
Placebo7-Point Ordinal Scale1: Not hospitalized, no limitations on activities - Day 28 (End of Study)7 Participants
Placebo7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 04 Participants
Placebo7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 35 Participants
Placebo7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 77 Participants
Placebo7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 107 Participants
Placebo7-Point Ordinal Scale2: Not hospitalized, limitation on activities - Day 28 (End of Study)6 Participants
Placebo7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 00 Participants
Placebo7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 30 Participants
Placebo7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 70 Participants
Placebo7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 100 Participants
Placebo7-Point Ordinal Scale3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study)0 Participants
Placebo7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 08 Participants
Placebo7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 36 Participants
Placebo7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 71 Participants
Placebo7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 100 Participants
Placebo7-Point Ordinal Scale4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study)0 Participants
Placebo7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 02 Participants
Placebo7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 31 Participants
Placebo7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 71 Participants
Placebo7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 102 Participants
Placebo7-Point Ordinal Scale5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study)0 Participants
Placebo7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 00 Participants
Placebo7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 30 Participants
Placebo7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 71 Participants
Placebo7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 100 Participants
Placebo7-Point Ordinal Scale6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study)0 Participants
Placebo7-Point Ordinal Scale7: Death - Day 00 Participants
Placebo7-Point Ordinal Scale7: Death - Day 30 Participants
Placebo7-Point Ordinal Scale7: Death - Day 70 Participants
Placebo7-Point Ordinal Scale7: Death - Day 101 Participants
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute BasophilsDay 100.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute BasophilsScreening0.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute BasophilsDay 00.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute BasophilsDay 30.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute BasophilsDay 70.0 cells x10^3/uLStandard Deviation 0
PlaceboAbsolute BasophilsScreening0.0 cells x10^3/uLStandard Deviation 0
PlaceboAbsolute BasophilsDay 30.0 cells x10^3/uLStandard Deviation 0
PlaceboAbsolute BasophilsDay 00.0 cells x10^3/uLStandard Deviation 0
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute EosinophilsDay 100.1 cells x10^3/uLStandard Deviation 0.1
HB-adMSCsAbsolute EosinophilsDay 30.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute EosinophilsDay 70.0 cells x10^3/uLStandard Deviation 0.1
HB-adMSCsAbsolute EosinophilsScreening0.1 cells x10^3/uLStandard Deviation 0.3
HB-adMSCsAbsolute EosinophilsDay 00.0 cells x10^3/uLStandard Deviation 0
PlaceboAbsolute EosinophilsScreening0.0 cells x10^3/uLStandard Deviation 0
PlaceboAbsolute EosinophilsDay 30.1 cells x10^3/uLStandard Deviation 0.2
PlaceboAbsolute EosinophilsDay 00.0 cells x10^3/uLStandard Deviation 0
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute Immature GranulocytesDay 100.0 cells x10^3/uLStandard Deviation 0.1
HB-adMSCsAbsolute Immature GranulocytesDay 30.2 cells x10^3/uLStandard Deviation 0.2
HB-adMSCsAbsolute Immature GranulocytesDay 70.1 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute Immature GranulocytesScreening0.0 cells x10^3/uLStandard Deviation 0
HB-adMSCsAbsolute Immature GranulocytesDay 00.1 cells x10^3/uLStandard Deviation 0.2
PlaceboAbsolute Immature GranulocytesScreening0.1 cells x10^3/uLStandard Deviation 0.2
PlaceboAbsolute Immature GranulocytesDay 30.3 cells x10^3/uLStandard Deviation 0.5
PlaceboAbsolute Immature GranulocytesDay 00.2 cells x10^3/uLStandard Deviation 0.2
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute LymphocytesScreening1.0 cells x10^3/uLStandard Deviation 0.6
HB-adMSCsAbsolute LymphocytesDay 01.0 cells x10^3/uLStandard Deviation 0.6
HB-adMSCsAbsolute LymphocytesDay 31.0 cells x10^3/uLStandard Deviation 0.7
HB-adMSCsAbsolute LymphocytesDay 70.8 cells x10^3/uLStandard Deviation 0.3
HB-adMSCsAbsolute LymphocytesDay 10261.1 cells x10^3/uLStandard Deviation 580.8
PlaceboAbsolute LymphocytesScreening1.1 cells x10^3/uLStandard Deviation 1.1
PlaceboAbsolute LymphocytesDay 31.9 cells x10^3/uLStandard Deviation 1.4
PlaceboAbsolute LymphocytesDay 01.4 cells x10^3/uLStandard Deviation 1.1
PlaceboAbsolute LymphocytesDay 102184.0 cells x10^3/uL
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute MonocytesDay 100.6 cells x10^3/uLStandard Deviation 0.4
HB-adMSCsAbsolute MonocytesDay 30.7 cells x10^3/uLStandard Deviation 0.5
HB-adMSCsAbsolute MonocytesDay 70.6 cells x10^3/uLStandard Deviation 0.6
HB-adMSCsAbsolute MonocytesScreening0.4 cells x10^3/uLStandard Deviation 0.3
HB-adMSCsAbsolute MonocytesDay 01.1 cells x10^3/uLStandard Deviation 2.5
PlaceboAbsolute MonocytesScreening0.5 cells x10^3/uLStandard Deviation 0.4
PlaceboAbsolute MonocytesDay 30.8 cells x10^3/uLStandard Deviation 0.4
PlaceboAbsolute MonocytesDay 00.5 cells x10^3/uLStandard Deviation 0.4
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAbsolute NeutrophilsDay 105.3 cells x 10^3/uLStandard Deviation 4.2
HB-adMSCsAbsolute NeutrophilsDay 315.4 cells x 10^3/uLStandard Deviation 15.6
HB-adMSCsAbsolute NeutrophilsDay 77.4 cells x 10^3/uLStandard Deviation 4.7
HB-adMSCsAbsolute NeutrophilsScreening7.0 cells x 10^3/uLStandard Deviation 3.8
HB-adMSCsAbsolute NeutrophilsDay 09.7 cells x 10^3/uLStandard Deviation 10.3
PlaceboAbsolute NeutrophilsScreening7.5 cells x 10^3/uLStandard Deviation 4.2
PlaceboAbsolute NeutrophilsDay 313.6 cells x 10^3/uLStandard Deviation 11.5
PlaceboAbsolute NeutrophilsDay 07.6 cells x 10^3/uLStandard Deviation 3.4
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAlanine Aminotransferase (SGPT)Day 038.5 IU/LStandard Deviation 39.7
HB-adMSCsAlanine Aminotransferase (SGPT)Day 746.4 IU/LStandard Deviation 39.7
HB-adMSCsAlanine Aminotransferase (SGPT)Screening50.8 IU/LStandard Deviation 58.3
HB-adMSCsAlanine Aminotransferase (SGPT)Day 1042.2 IU/LStandard Deviation 29.3
HB-adMSCsAlanine Aminotransferase (SGPT)Day 368.0 IU/LStandard Deviation 78.8
PlaceboAlanine Aminotransferase (SGPT)Day 1070.8 IU/LStandard Deviation 83.4
PlaceboAlanine Aminotransferase (SGPT)Day 057.2 IU/LStandard Deviation 38.6
PlaceboAlanine Aminotransferase (SGPT)Day 3107.0 IU/LStandard Deviation 122.3
PlaceboAlanine Aminotransferase (SGPT)Day 7108.7 IU/LStandard Deviation 106.2
PlaceboAlanine Aminotransferase (SGPT)Screening77.0 IU/LStandard Deviation 124.5
Secondary

Albumin

Clinical lab evaluation of level of Albumin in the blood (g/dL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAlbuminDay 03.4 g/dLStandard Deviation 0.5
HB-adMSCsAlbuminDay 73.2 g/dLStandard Deviation 0.8
HB-adMSCsAlbuminDay 33.2 g/dLStandard Deviation 0.7
HB-adMSCsAlbuminDay 103.4 g/dLStandard Deviation 0.8
HB-adMSCsAlbuminScreening3.4 g/dLStandard Deviation 0.5
PlaceboAlbuminDay 103.9 g/dLStandard Deviation 0.4
PlaceboAlbuminScreening3.6 g/dLStandard Deviation 0.6
PlaceboAlbuminDay 03.5 g/dLStandard Deviation 0.6
PlaceboAlbuminDay 33.4 g/dLStandard Deviation 0.6
PlaceboAlbuminDay 73.5 g/dLStandard Deviation 0.8
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAlbumin/Globulin (A/G) RatioDay 31.5 RatioStandard Deviation 0.4
HB-adMSCsAlbumin/Globulin (A/G) RatioDay 01.4 RatioStandard Deviation 0.3
HB-adMSCsAlbumin/Globulin (A/G) RatioDay 71.4 RatioStandard Deviation 0.3
HB-adMSCsAlbumin/Globulin (A/G) RatioDay 101.3 RatioStandard Deviation 0.4
PlaceboAlbumin/Globulin (A/G) RatioDay 101.7 RatioStandard Deviation 0.4
PlaceboAlbumin/Globulin (A/G) RatioDay 01.3 RatioStandard Deviation 0.3
PlaceboAlbumin/Globulin (A/G) RatioDay 31.5 RatioStandard Deviation 0.4
PlaceboAlbumin/Globulin (A/G) RatioDay 71.4 RatioStandard Deviation 0.4
UnknownAlbumin/Globulin (A/G) RatioScreening Ratio
Secondary

Alkaline Phosphatase

Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAlkaline PhosphataseDay 084.9 IU/LStandard Deviation 35.3
HB-adMSCsAlkaline PhosphataseDay 783.9 IU/LStandard Deviation 35
HB-adMSCsAlkaline PhosphataseDay 3101.8 IU/LStandard Deviation 71.1
HB-adMSCsAlkaline PhosphataseDay 1094.2 IU/LStandard Deviation 47.3
HB-adMSCsAlkaline PhosphataseScreening85.5 IU/LStandard Deviation 37.2
PlaceboAlkaline PhosphataseDay 1079.1 IU/LStandard Deviation 19.3
PlaceboAlkaline PhosphataseScreening71.9 IU/LStandard Deviation 19.8
PlaceboAlkaline PhosphataseDay 066.5 IU/LStandard Deviation 21.6
PlaceboAlkaline PhosphataseDay 367.7 IU/LStandard Deviation 22.1
PlaceboAlkaline PhosphataseDay 786.6 IU/LStandard Deviation 15.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsAspartate Aminotransferase (SGOT)Day 741.4 IU/LStandard Deviation 52.7
HB-adMSCsAspartate Aminotransferase (SGOT)Screening41.9 IU/LStandard Deviation 33.3
HB-adMSCsAspartate Aminotransferase (SGOT)Day 369.7 IU/LStandard Deviation 117.3
HB-adMSCsAspartate Aminotransferase (SGOT)Day 1036.6 IU/LStandard Deviation 20
HB-adMSCsAspartate Aminotransferase (SGOT)Day 030.0 IU/LStandard Deviation 18.3
PlaceboAspartate Aminotransferase (SGOT)Day 1027.6 IU/LStandard Deviation 10.1
PlaceboAspartate Aminotransferase (SGOT)Day 038.2 IU/LStandard Deviation 26.4
PlaceboAspartate Aminotransferase (SGOT)Day 347.3 IU/LStandard Deviation 33.9
PlaceboAspartate Aminotransferase (SGOT)Day 746.1 IU/LStandard Deviation 32.8
PlaceboAspartate Aminotransferase (SGOT)Screening41.1 IU/LStandard Deviation 28.2
Secondary

Basophils

Clinical lab evaluation of level of Basophils in the blood (%)

Time frame: Screening, Day 0, 3, 7 and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsBasophilsDay 00.1 % of BasophilsStandard Deviation 0.4
HB-adMSCsBasophilsDay 70.4 % of BasophilsStandard Deviation 0.7
HB-adMSCsBasophilsDay 30.2 % of BasophilsStandard Deviation 0.3
HB-adMSCsBasophilsDay 100.4 % of BasophilsStandard Deviation 0.9
HB-adMSCsBasophilsScreening0.3 % of BasophilsStandard Deviation 0.4
PlaceboBasophilsDay 100.2 % of BasophilsStandard Deviation 0.3
PlaceboBasophilsScreening0.1 % of BasophilsStandard Deviation 0.2
PlaceboBasophilsDay 00.1 % of BasophilsStandard Deviation 0.3
PlaceboBasophilsDay 30.0 % of BasophilsStandard Deviation 0
PlaceboBasophilsDay 70.8 % of BasophilsStandard Deviation 0.9
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsBilirubin TotalDay 30.7 mg/dLStandard Deviation 0.8
HB-adMSCsBilirubin TotalDay 70.5 mg/dLStandard Deviation 0.2
HB-adMSCsBilirubin TotalDay 100.5 mg/dLStandard Deviation 0.2
HB-adMSCsBilirubin TotalScreening0.6 mg/dLStandard Deviation 0.4
HB-adMSCsBilirubin TotalDay 00.4 mg/dLStandard Deviation 0.2
PlaceboBilirubin TotalDay 00.4 mg/dLStandard Deviation 0.3
PlaceboBilirubin TotalScreening0.5 mg/dLStandard Deviation 0.2
PlaceboBilirubin TotalDay 70.5 mg/dLStandard Deviation 0.4
PlaceboBilirubin TotalDay 30.4 mg/dLStandard Deviation 0.2
PlaceboBilirubin TotalDay 100.6 mg/dLStandard Deviation 0.5
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsBlood Urea Nitrogen (BUN)Day 022.9 mg/dLStandard Deviation 17.4
HB-adMSCsBlood Urea Nitrogen (BUN)Day 728.4 mg/dLStandard Deviation 28.1
HB-adMSCsBlood Urea Nitrogen (BUN)Day 324.0 mg/dLStandard Deviation 18.5
HB-adMSCsBlood Urea Nitrogen (BUN)Day 1019.8 mg/dLStandard Deviation 12.1
HB-adMSCsBlood Urea Nitrogen (BUN)Screening19.7 mg/dLStandard Deviation 14.3
PlaceboBlood Urea Nitrogen (BUN)Day 1014.9 mg/dLStandard Deviation 6
PlaceboBlood Urea Nitrogen (BUN)Screening14.3 mg/dLStandard Deviation 5.8
PlaceboBlood Urea Nitrogen (BUN)Day 015.6 mg/dLStandard Deviation 4.8
PlaceboBlood Urea Nitrogen (BUN)Day 312.7 mg/dLStandard Deviation 4.4
PlaceboBlood Urea Nitrogen (BUN)Day 719.9 mg/dLStandard Deviation 7.8
Secondary

BUN/Creatinine Ratio

Clinical lab evaluation of BUN/Creatinine Ratio in the blood

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsBUN/Creatinine RatioDay 022.9 RatioStandard Deviation 11
HB-adMSCsBUN/Creatinine RatioDay 730.3 RatioStandard Deviation 24.6
HB-adMSCsBUN/Creatinine RatioDay 322.4 RatioStandard Deviation 6.9
HB-adMSCsBUN/Creatinine RatioDay 1020.2 RatioStandard Deviation 7.9
HB-adMSCsBUN/Creatinine RatioScreening18.1 RatioStandard Deviation 6.6
PlaceboBUN/Creatinine RatioDay 1018.4 RatioStandard Deviation 7.6
PlaceboBUN/Creatinine RatioScreening18.9 RatioStandard Deviation 2.7
PlaceboBUN/Creatinine RatioDay 020.7 RatioStandard Deviation 4.7
PlaceboBUN/Creatinine RatioDay 319.2 RatioStandard Deviation 5.8
PlaceboBUN/Creatinine RatioDay 726.1 RatioStandard Deviation 8
Secondary

Calcium

Clinical lab evaluation of level of Calcium in the blood (mg/dL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsCalciumDay 08.4 mg/dLStandard Deviation 0.5
HB-adMSCsCalciumDay 78.4 mg/dLStandard Deviation 1.1
HB-adMSCsCalciumDay 38.3 mg/dLStandard Deviation 0.7
HB-adMSCsCalciumDay 108.6 mg/dLStandard Deviation 1.1
HB-adMSCsCalciumScreening8.6 mg/dLStandard Deviation 0.5
PlaceboCalciumDay 109.1 mg/dLStandard Deviation 0.4
PlaceboCalciumScreening8.7 mg/dLStandard Deviation 0.6
PlaceboCalciumDay 08.3 mg/dLStandard Deviation 0.7
PlaceboCalciumDay 38.3 mg/dLStandard Deviation 0.8
PlaceboCalciumDay 78.7 mg/dLStandard Deviation 0.9
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsCarbon Dioxide TotalDay 723.8 mmol/LStandard Deviation 3.5
HB-adMSCsCarbon Dioxide TotalScreening25.2 mmol/LStandard Deviation 4.5
HB-adMSCsCarbon Dioxide TotalDay 024.1 mmol/LStandard Deviation 4.8
HB-adMSCsCarbon Dioxide TotalDay 324.6 mmol/LStandard Deviation 4
HB-adMSCsCarbon Dioxide TotalDay 1021.9 mmol/LStandard Deviation 3.8
PlaceboCarbon Dioxide TotalDay 325.3 mmol/LStandard Deviation 2.8
PlaceboCarbon Dioxide TotalDay 1025.4 mmol/LStandard Deviation 3.1
PlaceboCarbon Dioxide TotalDay 726.3 mmol/LStandard Deviation 2.8
PlaceboCarbon Dioxide TotalDay 025.3 mmol/LStandard Deviation 4.4
PlaceboCarbon Dioxide TotalScreening25.4 mmol/LStandard Deviation 3.1
Secondary

CD4+/CD8+ Ratio

Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood

Time frame: Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsCD4+/CD8+ RatioDay 02.5 RatioStandard Deviation 1.7
HB-adMSCsCD4+/CD8+ RatioDay 72.4 RatioStandard Deviation 1.4
HB-adMSCsCD4+/CD8+ RatioDay 32.5 RatioStandard Deviation 1.3
HB-adMSCsCD4+/CD8+ RatioDay 102.4 RatioStandard Deviation 0.9
PlaceboCD4+/CD8+ RatioDay 102.3 RatioStandard Deviation 1.3
PlaceboCD4+/CD8+ RatioDay 01.9 RatioStandard Deviation 0.9
PlaceboCD4+/CD8+ RatioDay 32.6 RatioStandard Deviation 1.7
PlaceboCD4+/CD8+ RatioDay 72.4 RatioStandard Deviation 1.4
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsChest X-Ray ScoreDay 02.9 Score on a Scale 0-25Standard Deviation 1.6
HB-adMSCsChest X-Ray ScoreDay 281.7 Score on a Scale 0-25Standard Deviation 1.6
PlaceboChest X-Ray ScoreDay 02.7 Score on a Scale 0-25Standard Deviation 0.6
PlaceboChest X-Ray ScoreDay 281.5 Score on a Scale 0-25Standard Deviation 2.1
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Secondary

Chloride

Clinical lab evaluation of level of Chloride in the blood (mmol/L)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsChlorideDay 0103.3 mmol/LStandard Deviation 3.7
HB-adMSCsChlorideDay 7102.5 mmol/LStandard Deviation 5.5
HB-adMSCsChlorideDay 3103.3 mmol/LStandard Deviation 4.2
HB-adMSCsChlorideDay 10101.9 mmol/LStandard Deviation 4.6
HB-adMSCsChlorideScreening103.0 mmol/LStandard Deviation 3.9
PlaceboChlorideDay 10104.1 mmol/LStandard Deviation 1.4
PlaceboChlorideScreening102.2 mmol/LStandard Deviation 2.9
PlaceboChlorideDay 0101.0 mmol/LStandard Deviation 4.4
PlaceboChlorideDay 3101.8 mmol/LStandard Deviation 4.1
PlaceboChlorideDay 7102.1 mmol/LStandard Deviation 2.1
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsComputed Tomography (CT) ScoreDay 02.9 Score on a Scale 0-25Standard Deviation 1.4
HB-adMSCsComputed Tomography (CT) ScoreDay 281.2 Score on a Scale 0-25Standard Deviation 1.6
PlaceboComputed Tomography (CT) ScoreDay 03.0 Score on a Scale 0-25Standard Deviation 0.9
PlaceboComputed Tomography (CT) ScoreDay 281.2 Score on a Scale 0-25Standard Deviation 1.2
Comparison: Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsCreatinine Kinase MB (CK-MB)Day 02.6 ng/mLStandard Deviation 2.6
HB-adMSCsCreatinine Kinase MB (CK-MB)Day 33.0 ng/mLStandard Deviation 4.6
HB-adMSCsCreatinine Kinase MB (CK-MB)Day 73.3 ng/mLStandard Deviation 2.9
HB-adMSCsCreatinine Kinase MB (CK-MB)Day 103.7 ng/mLStandard Deviation 3.9
PlaceboCreatinine Kinase MB (CK-MB)Day 101.9 ng/mL
PlaceboCreatinine Kinase MB (CK-MB)Day 02.0 ng/mLStandard Deviation 1.1
PlaceboCreatinine Kinase MB (CK-MB)Day 72.3 ng/mLStandard Deviation 1.4
PlaceboCreatinine Kinase MB (CK-MB)Day 32.2 ng/mLStandard Deviation 1.2
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsD-dimerDay 70.7 mg/LStandard Deviation 0.5
HB-adMSCsD-dimerDay 31.2 mg/LStandard Deviation 1.7
HB-adMSCsD-dimerDay 106.8 mg/LStandard Deviation 7.7
HB-adMSCsD-dimerDay 01.3 mg/LStandard Deviation 1.4
PlaceboD-dimerDay 32.3 mg/LStandard Deviation 2.8
PlaceboD-dimerDay 02.1 mg/LStandard Deviation 2.6
PlaceboD-dimerDay 713.6 mg/LStandard Deviation 9.1
Secondary

Eosinophils

Clinical lab evaluation of level of Eosinophils n the blood (%)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsEosinophilsDay 30.2 % of EosinophilsStandard Deviation 0.6
HB-adMSCsEosinophilsDay 00.2 % of EosinophilsStandard Deviation 0.5
HB-adMSCsEosinophilsDay 72.5 % of EosinophilsStandard Deviation 9.2
HB-adMSCsEosinophilsDay 101.1 % of EosinophilsStandard Deviation 1.4
HB-adMSCsEosinophilsScreening1.1 % of EosinophilsStandard Deviation 3.1
PlaceboEosinophilsDay 101.0 % of EosinophilsStandard Deviation 1.1
PlaceboEosinophilsScreening0.1 % of EosinophilsStandard Deviation 0.5
PlaceboEosinophilsDay 00.3 % of EosinophilsStandard Deviation 0.5
PlaceboEosinophilsDay 30.8 % of EosinophilsStandard Deviation 1.4
PlaceboEosinophilsDay 70.7 % of EosinophilsStandard Deviation 1
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 778.8 mL/min/1.73Standard Deviation 50.1
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 398.2 mL/min/1.73Standard Deviation 58.9
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 1078.4 mL/min/1.73Standard Deviation 45.7
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if African AmericanScreening106.4 mL/min/1.73Standard Deviation 37.3
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 074.3 mL/min/1.73Standard Deviation 42.7
PlaceboEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 1094.5 mL/min/1.73Standard Deviation 26.2
PlaceboEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 0107.0 mL/min/1.73
PlaceboEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 397.0 mL/min/1.73
PlaceboEstimated Glomerular Filtration Rate (eGFR) if African AmericanDay 7107.0 mL/min/1.73
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 3113.4 mL/min/1.73Standard Deviation 25.2
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 7102.8 mL/min/1.73Standard Deviation 44.8
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 10107.0 mL/min/1.73Standard Deviation 36
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanScreening230.3 mL/min/1.73Standard Deviation 270.1
HB-adMSCsEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 0143.0 mL/min/1.73Standard Deviation 103.8
PlaceboEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 0117.0 mL/min/1.73Standard Deviation 33.9
PlaceboEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanScreening127.1 mL/min/1.73Standard Deviation 30.7
PlaceboEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 7109.6 mL/min/1.73Standard Deviation 16.5
PlaceboEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 3112.8 mL/min/1.73Standard Deviation 22.4
PlaceboEstimated Glomerular Filtration Rate (eGFR) if Non-African AmericanDay 10108.0 mL/min/1.73Standard Deviation 18
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsGlobulin TotalDay 02.6 g/dLStandard Deviation 0.5
HB-adMSCsGlobulin TotalDay 72.5 g/dLStandard Deviation 0.5
HB-adMSCsGlobulin TotalDay 32.5 g/dLStandard Deviation 0.5
HB-adMSCsGlobulin TotalDay 102.6 g/dLStandard Deviation 0.6
HB-adMSCsGlobulin TotalScreening2.8 g/dLStandard Deviation 0.6
PlaceboGlobulin TotalDay 102.3 g/dLStandard Deviation 0.4
PlaceboGlobulin TotalScreening2.9 g/dLStandard Deviation 0.5
PlaceboGlobulin TotalDay 02.6 g/dLStandard Deviation 0.4
PlaceboGlobulin TotalDay 32.6 g/dLStandard Deviation 0.5
PlaceboGlobulin TotalDay 72.6 g/dLStandard Deviation 0.4
Secondary

Glucose

Clinical lab evaluation of level of Glucose in the blood (mg/dL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsGlucoseDay 0153.4 mg/dLStandard Deviation 89
HB-adMSCsGlucoseDay 7175.7 mg/dLStandard Deviation 106.4
HB-adMSCsGlucoseDay 3148.2 mg/dLStandard Deviation 74.8
HB-adMSCsGlucoseDay 10166.9 mg/dLStandard Deviation 110
HB-adMSCsGlucoseScreening139.3 mg/dLStandard Deviation 58
PlaceboGlucoseDay 10129.8 mg/dLStandard Deviation 74.4
PlaceboGlucoseScreening148.1 mg/dLStandard Deviation 55.4
PlaceboGlucoseDay 0165.4 mg/dLStandard Deviation 52.5
PlaceboGlucoseDay 3145.6 mg/dLStandard Deviation 58.7
PlaceboGlucoseDay 7165.7 mg/dLStandard Deviation 37.5
Secondary

Hematocrit

Clinical lab evaluation of level of Hematocrit in the blood (%)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsHematocritDay 037.3 % of RBCsStandard Deviation 6.8
HB-adMSCsHematocritDay 733.2 % of RBCsStandard Deviation 6.3
HB-adMSCsHematocritDay 336.0 % of RBCsStandard Deviation 7.7
HB-adMSCsHematocritDay 1034.6 % of RBCsStandard Deviation 8.3
HB-adMSCsHematocritScreening37.3 % of RBCsStandard Deviation 6.7
PlaceboHematocritDay 1036.7 % of RBCsStandard Deviation 4.5
PlaceboHematocritScreening39.5 % of RBCsStandard Deviation 6.3
PlaceboHematocritDay 038.8 % of RBCsStandard Deviation 8.7
PlaceboHematocritDay 338.0 % of RBCsStandard Deviation 6.3
PlaceboHematocritDay 739.6 % of RBCsStandard Deviation 7.8
Secondary

Hemoglobin

Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsHemoglobinDay 011.9 g/dLStandard Deviation 2.5
HB-adMSCsHemoglobinDay 710.8 g/dLStandard Deviation 2.2
HB-adMSCsHemoglobinDay 311.6 g/dLStandard Deviation 2.7
HB-adMSCsHemoglobinDay 1011.1 g/dLStandard Deviation 2.8
HB-adMSCsHemoglobinScreening12.0 g/dLStandard Deviation 2.5
PlaceboHemoglobinDay 1012.4 g/dLStandard Deviation 1.7
PlaceboHemoglobinScreening12.8 g/dLStandard Deviation 2.3
PlaceboHemoglobinDay 012.5 g/dLStandard Deviation 3.1
PlaceboHemoglobinDay 312.1 g/dLStandard Deviation 2
PlaceboHemoglobinDay 713.4 g/dLStandard Deviation 2.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsImmature GranulocytesDay 100.6 % of Immature GranulocytesStandard Deviation 0.5
HB-adMSCsImmature GranulocytesDay 31.6 % of Immature GranulocytesStandard Deviation 1.7
HB-adMSCsImmature GranulocytesDay 71.0 % of Immature GranulocytesStandard Deviation 0.8
HB-adMSCsImmature GranulocytesScreening0.4 % of Immature GranulocytesStandard Deviation 0.6
HB-adMSCsImmature GranulocytesDay 01.0 % of Immature GranulocytesStandard Deviation 1.1
PlaceboImmature GranulocytesScreening1.2 % of Immature GranulocytesStandard Deviation 1.1
PlaceboImmature GranulocytesDay 31.4 % of Immature GranulocytesStandard Deviation 1.1
PlaceboImmature GranulocytesDay 01.8 % of Immature GranulocytesStandard Deviation 1.5
Secondary

International Normalized Ratio (INR)

Clinical lab evaluation of International Normalized Ratio (INR)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsInternational Normalized Ratio (INR)Day 71.2 RatioStandard Deviation 0.4
HB-adMSCsInternational Normalized Ratio (INR)Day 01.2 RatioStandard Deviation 0.3
HB-adMSCsInternational Normalized Ratio (INR)Screening1.1 RatioStandard Deviation 0.1
HB-adMSCsInternational Normalized Ratio (INR)Day 101.4 RatioStandard Deviation 0.6
HB-adMSCsInternational Normalized Ratio (INR)Day 31.2 RatioStandard Deviation 0.3
PlaceboInternational Normalized Ratio (INR)Day 101.1 RatioStandard Deviation 0.2
PlaceboInternational Normalized Ratio (INR)Day 31.1 RatioStandard Deviation 0.1
PlaceboInternational Normalized Ratio (INR)Day 71.1 RatioStandard Deviation 0.1
PlaceboInternational Normalized Ratio (INR)Screening1.1 RatioStandard Deviation 0.1
PlaceboInternational Normalized Ratio (INR)Day 01.1 RatioStandard Deviation 0.1
Secondary

Lymphocytes

Clinical lab evaluation of level of Lymphocytes in the blood (%)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsLymphocytesDay 011.3 Percentage of Lymphocytes (%)Standard Deviation 8.2
HB-adMSCsLymphocytesDay 717.4 Percentage of Lymphocytes (%)Standard Deviation 13.3
HB-adMSCsLymphocytesDay 314.5 Percentage of Lymphocytes (%)Standard Deviation 13.9
HB-adMSCsLymphocytesDay 1017.0 Percentage of Lymphocytes (%)Standard Deviation 11.8
HB-adMSCsLymphocytesScreening14.4 Percentage of Lymphocytes (%)Standard Deviation 11.4
PlaceboLymphocytesDay 1025.7 Percentage of Lymphocytes (%)Standard Deviation 14.2
PlaceboLymphocytesScreening16.0 Percentage of Lymphocytes (%)Standard Deviation 11.1
PlaceboLymphocytesDay 012.1 Percentage of Lymphocytes (%)Standard Deviation 7.9
PlaceboLymphocytesDay 317.2 Percentage of Lymphocytes (%)Standard Deviation 12.7
PlaceboLymphocytesDay 716.8 Percentage of Lymphocytes (%)Standard Deviation 13.5
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsMean Corpuscular Hemoglobin Concentration (MCHC)Day 031.9 g/dLStandard Deviation 2
HB-adMSCsMean Corpuscular Hemoglobin Concentration (MCHC)Day 732.6 g/dLStandard Deviation 2.1
HB-adMSCsMean Corpuscular Hemoglobin Concentration (MCHC)Day 332.1 g/dLStandard Deviation 1.9
HB-adMSCsMean Corpuscular Hemoglobin Concentration (MCHC)Day 1031.9 g/dLStandard Deviation 2
HB-adMSCsMean Corpuscular Hemoglobin Concentration (MCHC)Screening32.0 g/dLStandard Deviation 1.8
PlaceboMean Corpuscular Hemoglobin Concentration (MCHC)Day 1033.7 g/dLStandard Deviation 0.8
PlaceboMean Corpuscular Hemoglobin Concentration (MCHC)Screening32.3 g/dLStandard Deviation 1.6
PlaceboMean Corpuscular Hemoglobin Concentration (MCHC)Day 032.0 g/dLStandard Deviation 1.8
PlaceboMean Corpuscular Hemoglobin Concentration (MCHC)Day 331.8 g/dLStandard Deviation 1.9
PlaceboMean Corpuscular Hemoglobin Concentration (MCHC)Day 733.6 g/dLStandard Deviation 1.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsMean Corpuscular Hemoglobin (MCH)Day 028.6 pgStandard Deviation 3.8
HB-adMSCsMean Corpuscular Hemoglobin (MCH)Day 728.3 pgStandard Deviation 3.9
HB-adMSCsMean Corpuscular Hemoglobin (MCH)Day 328.8 pgStandard Deviation 3.9
HB-adMSCsMean Corpuscular Hemoglobin (MCH)Day 1028.7 pgStandard Deviation 3.1
HB-adMSCsMean Corpuscular Hemoglobin (MCH)Screening28.5 pgStandard Deviation 3.9
PlaceboMean Corpuscular Hemoglobin (MCH)Day 1028.7 pgStandard Deviation 1
PlaceboMean Corpuscular Hemoglobin (MCH)Screening45.4 pgStandard Deviation 67.6
PlaceboMean Corpuscular Hemoglobin (MCH)Day 027.8 pgStandard Deviation 2.5
PlaceboMean Corpuscular Hemoglobin (MCH)Day 327.4 pgStandard Deviation 2.9
PlaceboMean Corpuscular Hemoglobin (MCH)Day 728.7 pgStandard Deviation 1.5
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsMean Corpuscular Volume (MCV)Day 786.8 fLStandard Deviation 9.5
HB-adMSCsMean Corpuscular Volume (MCV)Day 1089.8 fLStandard Deviation 8.7
HB-adMSCsMean Corpuscular Volume (MCV)Screening88.8 fLStandard Deviation 9.7
HB-adMSCsMean Corpuscular Volume (MCV)Day 089.6 fLStandard Deviation 8.9
HB-adMSCsMean Corpuscular Volume (MCV)Day 389.4 fLStandard Deviation 9.8
PlaceboMean Corpuscular Volume (MCV)Day 385.8 fLStandard Deviation 6.2
PlaceboMean Corpuscular Volume (MCV)Day 086.8 fLStandard Deviation 6
PlaceboMean Corpuscular Volume (MCV)Day 1085.0 fLStandard Deviation 1.9
PlaceboMean Corpuscular Volume (MCV)Day 785.2 fLStandard Deviation 3.2
PlaceboMean Corpuscular Volume (MCV)Screening86.9 fLStandard Deviation 4.4
Secondary

Monocytes

Clinical lab evaluation of level of Monocytes in the blood (%)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsMonocytesDay 35.4 % of MonocytesStandard Deviation 2.9
HB-adMSCsMonocytesDay 75.4 % of MonocytesStandard Deviation 3.1
HB-adMSCsMonocytesDay 105.2 % of MonocytesStandard Deviation 3.6
HB-adMSCsMonocytesScreening5.7 % of MonocytesStandard Deviation 3.3
HB-adMSCsMonocytesDay 05.4 % of MonocytesStandard Deviation 3.6
PlaceboMonocytesDay 04.9 % of MonocytesStandard Deviation 2.2
PlaceboMonocytesScreening5.4 % of MonocytesStandard Deviation 2.7
PlaceboMonocytesDay 75.5 % of MonocytesStandard Deviation 4.8
PlaceboMonocytesDay 35.8 % of MonocytesStandard Deviation 4
PlaceboMonocytesDay 106.5 % of MonocytesStandard Deviation 3.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsMyoglobinDay 3142.3 ng/mLStandard Deviation 155.8
HB-adMSCsMyoglobinDay 721.5 ng/mLStandard Deviation 0.7
HB-adMSCsMyoglobinDay 0183.0 ng/mL
HB-adMSCsMyoglobinDay 1050.3 ng/mLStandard Deviation 48.2
PlaceboMyoglobinDay 021.0 ng/mL
PlaceboMyoglobinDay 3100.0 ng/mL
Secondary

Neutrophils

Clinical lab evaluation of level of Neutrophils in the blood (%)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsNeutrophilsDay 079.4 % of NeutrophilsStandard Deviation 15.4
HB-adMSCsNeutrophilsDay 773.5 % of NeutrophilsStandard Deviation 15.6
HB-adMSCsNeutrophilsDay 377.0 % of NeutrophilsStandard Deviation 15.3
HB-adMSCsNeutrophilsDay 1075.1 % of NeutrophilsStandard Deviation 13.3
HB-adMSCsNeutrophilsScreening78.3 % of NeutrophilsStandard Deviation 14.6
PlaceboNeutrophilsDay 1066.2 % of NeutrophilsStandard Deviation 17.2
PlaceboNeutrophilsScreening75.8 % of NeutrophilsStandard Deviation 16.1
PlaceboNeutrophilsDay 080.7 % of NeutrophilsStandard Deviation 11.3
PlaceboNeutrophilsDay 375.3 % of NeutrophilsStandard Deviation 15.9
PlaceboNeutrophilsDay 775.7 % of NeutrophilsStandard Deviation 16.6
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsNK Cell Surface Antigen (CD3-CD56+)Day 066.4 % of CellsStandard Deviation 58.5
HB-adMSCsNK Cell Surface Antigen (CD3-CD56+)Day 721.9 % of CellsStandard Deviation 30.3
PlaceboNK Cell Surface Antigen (CD3-CD56+)Day 06.9 % of Cells
PlaceboNK Cell Surface Antigen (CD3-CD56+)Day 3320.0 % of Cells
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsPartial Thromboplastin Time (PTT)Day 031.6 secondsStandard Deviation 6.6
HB-adMSCsPartial Thromboplastin Time (PTT)Screening32.0 secondsStandard Deviation 5.5
HB-adMSCsPartial Thromboplastin Time (PTT)Day 332.2 secondsStandard Deviation 5.8
HB-adMSCsPartial Thromboplastin Time (PTT)Day 731.0 secondsStandard Deviation 6.9
HB-adMSCsPartial Thromboplastin Time (PTT)Day 1024.5 secondsStandard Deviation 12.7
PlaceboPartial Thromboplastin Time (PTT)Day 029.8 secondsStandard Deviation 4.2
PlaceboPartial Thromboplastin Time (PTT)Day 326.5 secondsStandard Deviation 6.4
PlaceboPartial Thromboplastin Time (PTT)Screening30.4 secondsStandard Deviation 3.8
PlaceboPartial Thromboplastin Time (PTT)Day 1028.2 secondsStandard Deviation 1.4
Secondary

Platelets

Clinical lab evaluation of level of Platelets in the blood (cells x10\^3/uL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsPlateletsDay 7273.1 cells x 10^3/uLStandard Deviation 119.6
HB-adMSCsPlateletsDay 10245.2 cells x 10^3/uLStandard Deviation 110.5
HB-adMSCsPlateletsScreening232.4 cells x 10^3/uLStandard Deviation 102.9
HB-adMSCsPlateletsDay 0237.5 cells x 10^3/uLStandard Deviation 98.8
HB-adMSCsPlateletsDay 3258.2 cells x 10^3/uLStandard Deviation 115.7
PlaceboPlateletsDay 3295.8 cells x 10^3/uLStandard Deviation 109
PlaceboPlateletsDay 0304.8 cells x 10^3/uLStandard Deviation 101.1
PlaceboPlateletsDay 10303.8 cells x 10^3/uLStandard Deviation 86.5
PlaceboPlateletsDay 7323.1 cells x 10^3/uLStandard Deviation 101.2
PlaceboPlateletsScreening282.1 cells x 10^3/uLStandard Deviation 122.8
Secondary

Potassium

Clinical lab evaluation of level of Potassium in the blood (mmol/L)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsPotassiumDay 04.1 mmol/LStandard Deviation 0.5
HB-adMSCsPotassiumDay 74.3 mmol/LStandard Deviation 1.3
HB-adMSCsPotassiumDay 33.9 mmol/LStandard Deviation 0.6
HB-adMSCsPotassiumDay 104.5 mmol/LStandard Deviation 1
HB-adMSCsPotassiumScreening4.2 mmol/LStandard Deviation 0.5
PlaceboPotassiumDay 104.2 mmol/LStandard Deviation 0.5
PlaceboPotassiumScreening4.2 mmol/LStandard Deviation 0.5
PlaceboPotassiumDay 04.1 mmol/LStandard Deviation 0.6
PlaceboPotassiumDay 34.0 mmol/LStandard Deviation 0.3
PlaceboPotassiumDay 74.5 mmol/LStandard Deviation 0.5
Secondary

Protein Total

Clinical lab evaluation of total level of Protein in the blood (g/dL)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsProtein TotalDay 05.9 g/dLStandard Deviation 0.7
HB-adMSCsProtein TotalDay 75.6 g/dLStandard Deviation 1.1
HB-adMSCsProtein TotalDay 35.7 g/dLStandard Deviation 0.8
HB-adMSCsProtein TotalDay 106.0 g/dLStandard Deviation 1.1
HB-adMSCsProtein TotalScreening6.2 g/dLStandard Deviation 0.9
PlaceboProtein TotalDay 106.3 g/dLStandard Deviation 0.4
PlaceboProtein TotalScreening6.5 g/dLStandard Deviation 0.8
PlaceboProtein TotalDay 06.0 g/dLStandard Deviation 0.8
PlaceboProtein TotalDay 36.0 g/dLStandard Deviation 0.7
PlaceboProtein TotalDay 76.1 g/dLStandard Deviation 0.6
Secondary

Prothrombin Time (PT)

Clinical lab evaluation of Prothrombin Time (seconds)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsProthrombin Time (PT)Screening11.5 secondsStandard Deviation 1.2
HB-adMSCsProthrombin Time (PT)Day 314.4 secondsStandard Deviation 3.1
HB-adMSCsProthrombin Time (PT)Day 1016.1 secondsStandard Deviation 5.8
HB-adMSCsProthrombin Time (PT)Day 715.3 secondsStandard Deviation 4.1
HB-adMSCsProthrombin Time (PT)Day 014.3 secondsStandard Deviation 3.9
PlaceboProthrombin Time (PT)Day 1014.3 secondsStandard Deviation 1.7
PlaceboProthrombin Time (PT)Screening12.0 secondsStandard Deviation 1.4
PlaceboProthrombin Time (PT)Day 012.9 secondsStandard Deviation 2
PlaceboProthrombin Time (PT)Day 313.9 secondsStandard Deviation 2
PlaceboProthrombin Time (PT)Day 714.6 secondsStandard Deviation 1.4
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsRed Blood Cell (RBC) CountDay 04.2 cells x 10^3/uLStandard Deviation 0.8
HB-adMSCsRed Blood Cell (RBC) CountDay 73.9 cells x 10^3/uLStandard Deviation 0.8
HB-adMSCsRed Blood Cell (RBC) CountDay 34.1 cells x 10^3/uLStandard Deviation 0.9
HB-adMSCsRed Blood Cell (RBC) CountDay 103.9 cells x 10^3/uLStandard Deviation 0.9
HB-adMSCsRed Blood Cell (RBC) CountScreening4.2 cells x 10^3/uLStandard Deviation 0.7
PlaceboRed Blood Cell (RBC) CountDay 104.3 cells x 10^3/uLStandard Deviation 0.5
PlaceboRed Blood Cell (RBC) CountScreening4.5 cells x 10^3/uLStandard Deviation 0.6
PlaceboRed Blood Cell (RBC) CountDay 04.5 cells x 10^3/uLStandard Deviation 1
PlaceboRed Blood Cell (RBC) CountDay 34.5 cells x 10^3/uLStandard Deviation 1
PlaceboRed Blood Cell (RBC) CountDay 74.6 cells x 10^3/uLStandard Deviation 0.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsRed Cell Distribution Width (RDW)Day 018.8 Red Cell Distribution Width %Standard Deviation 23.5
HB-adMSCsRed Cell Distribution Width (RDW)Day 715.5 Red Cell Distribution Width %Standard Deviation 4.5
HB-adMSCsRed Cell Distribution Width (RDW)Day 315.3 Red Cell Distribution Width %Standard Deviation 4.8
HB-adMSCsRed Cell Distribution Width (RDW)Day 1014.9 Red Cell Distribution Width %Standard Deviation 2.1
HB-adMSCsRed Cell Distribution Width (RDW)Screening14.4 Red Cell Distribution Width %Standard Deviation 1.9
PlaceboRed Cell Distribution Width (RDW)Day 1014.3 Red Cell Distribution Width %Standard Deviation 1.2
PlaceboRed Cell Distribution Width (RDW)Screening13.9 Red Cell Distribution Width %Standard Deviation 1.4
PlaceboRed Cell Distribution Width (RDW)Day 014.1 Red Cell Distribution Width %Standard Deviation 1.5
PlaceboRed Cell Distribution Width (RDW)Day 314.3 Red Cell Distribution Width %Standard Deviation 2.1
PlaceboRed Cell Distribution Width (RDW)Day 713.7 Red Cell Distribution Width %Standard Deviation 0.9
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsSerum FerritinDay 7753.9 ng/mLStandard Deviation 449.4
HB-adMSCsSerum FerritinDay 10509.0 ng/mLStandard Deviation 384.9
HB-adMSCsSerum FerritinDay 0420.5 ng/mLStandard Deviation 406
HB-adMSCsSerum FerritinDay 3499.6 ng/mLStandard Deviation 424.2
PlaceboSerum FerritinDay 3391.2 ng/mLStandard Deviation 324
PlaceboSerum FerritinDay 7361.0 ng/mLStandard Deviation 397.8
PlaceboSerum FerritinDay 0423.5 ng/mLStandard Deviation 387.9
PlaceboSerum FerritinDay 1063.2 ng/mL
Secondary

Sodium

Clinical lab evaluation of level of Sodium in the blood (mmol/L)

Time frame: Screening, Day 0, 3, 7, and 10

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsSodiumDay 0139.4 mmol/LStandard Deviation 3.6
HB-adMSCsSodiumDay 7132.3 mmol/LStandard Deviation 29.6
HB-adMSCsSodiumDay 3140.6 mmol/LStandard Deviation 3.3
HB-adMSCsSodiumDay 10139.2 mmol/LStandard Deviation 4.4
HB-adMSCsSodiumScreening137.8 mmol/LStandard Deviation 3.5
PlaceboSodiumDay 10141.2 mmol/LStandard Deviation 1.9
PlaceboSodiumScreening136.9 mmol/LStandard Deviation 3.5
PlaceboSodiumDay 0137.9 mmol/LStandard Deviation 3.5
PlaceboSodiumDay 3140.0 mmol/LStandard Deviation 2.8
PlaceboSodiumDay 7139.3 mmol/LStandard Deviation 3.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsTroponinDay 30.0 ng/mLStandard Deviation 0
HB-adMSCsTroponinDay 00.5 ng/mLStandard Deviation 1.8
HB-adMSCsTroponinDay 70.1 ng/mLStandard Deviation 0.2
HB-adMSCsTroponinDay 100.0 ng/mLStandard Deviation 0
PlaceboTroponinDay 30.0 ng/mL
PlaceboTroponinDay 00.0 ng/mLStandard Deviation 0
PlaceboTroponinDay 70.0 ng/mL
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
HB-adMSCsWhite Blood Count (WBC)Day 011.3 cells x 10^3/uLStandard Deviation 10.5
HB-adMSCsWhite Blood Count (WBC)Day 712.1 cells x 10^3/uLStandard Deviation 5.8
HB-adMSCsWhite Blood Count (WBC)Day 313.5 cells x 10^3/uLStandard Deviation 11.3
HB-adMSCsWhite Blood Count (WBC)Day 1010.4 cells x 10^3/uLStandard Deviation 5
HB-adMSCsWhite Blood Count (WBC)Screening8.4 cells x 10^3/uLStandard Deviation 4
PlaceboWhite Blood Count (WBC)Day 1011.4 cells x 10^3/uLStandard Deviation 5.8
PlaceboWhite Blood Count (WBC)Screening8.6 cells x 10^3/uLStandard Deviation 5
PlaceboWhite Blood Count (WBC)Day 010.3 cells x 10^3/uLStandard Deviation 3.6
PlaceboWhite Blood Count (WBC)Day 313.8 cells x 10^3/uLStandard Deviation 8.7
PlaceboWhite Blood Count (WBC)Day 712.7 cells x 10^3/uLStandard Deviation 5.5

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026