Trial Outcomes & Findings for Use of UC-MSCs for COVID-19 Patients (NCT NCT04355728)

Last Updated: 2021-12-06

Results Overview

Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion: 1. An increase in vasopressor dose greater than or equal to the following: * Norepinephrine: 10 μg/min * Phenylephrine: 100 μg/min * Dopamine: 10 μg/kg/min * Epinephrine: 10 μg/min 2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of \>20%. 3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation. 4. New cardiac arrhythmia requiring cardioversion 5. New ventricular tachycardia, ventricular fibrillation, or asystole 6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection 7. Cardiac arrest or death within 24h post infusion

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 and 24 hours

Results posted on

2021-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	UC-MSCs Group Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data missing. CBC with differential at baseline was not done in a subset of patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=12 Participants	7 Participants n=12 Participants	15 Participants n=24 Participants
Age, Categorical >=65 years	4 Participants n=12 Participants	5 Participants n=12 Participants	9 Participants n=24 Participants
Age, Continuous	58.58 years STANDARD_DEVIATION 15.93 • n=12 Participants	58.83 years STANDARD_DEVIATION 11.61 • n=12 Participants	58.71 years STANDARD_DEVIATION 13.63 • n=24 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	4 Participants n=12 Participants	11 Participants n=24 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	8 Participants n=12 Participants	13 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=12 Participants	11 Participants n=12 Participants	22 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=12 Participants	1 Participants n=12 Participants	2 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=12 Participants	2 Participants n=12 Participants	3 Participants n=24 Participants
Race (NIH/OMB) White	11 Participants n=12 Participants	10 Participants n=12 Participants	21 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Region of Enrollment United States	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants
Hemogoblin from Complete Blood Count	12.93 g/dL STANDARD_DEVIATION 2.04 • n=12 Participants	12.45 g/dL STANDARD_DEVIATION 2.35 • n=12 Participants	12.69 g/dL STANDARD_DEVIATION 2.17 • n=24 Participants
Hematocrit from Complete Blood Count	39.71 percentage of total blood volume STANDARD_DEVIATION 6.53 • n=11 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	40.76 percentage of total blood volume STANDARD_DEVIATION 5.08 • n=9 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	40.18 percentage of total blood volume STANDARD_DEVIATION 5.79 • n=20 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.
White Blood Count (WBC) from Complete Blood Count	11.87 10^3 cells/uL STANDARD_DEVIATION 5.26 • n=12 Participants	14.17 10^3 cells/uL STANDARD_DEVIATION 5.45 • n=12 Participants	13.02 10^3 cells/uL STANDARD_DEVIATION 5.37 • n=24 Participants
Neutrophils from Complete Blood Count	9.25 10^3 cells/uL STANDARD_DEVIATION 4.8 • n=11 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	13.37 10^3 cells/uL STANDARD_DEVIATION 5.33 • n=10 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	11.21 10^3 cells/uL STANDARD_DEVIATION 5.36 • n=21 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.
Lymphocytes from Complete Blood Count	1.15 10^3 cells/uL STANDARD_DEVIATION 0.79 • n=11 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	0.72 10^3 cells/uL STANDARD_DEVIATION 0.25 • n=10 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.	0.95 10^3 cells/uL STANDARD_DEVIATION 0.62 • n=21 Participants • Data missing. CBC with differential at baseline was not done in a subset of patients.
Platelet count from Complete Blood Count	329.83 10^3 cells/uL STANDARD_DEVIATION 99.52 • n=12 Participants	342.58 10^3 cells/uL STANDARD_DEVIATION 91.83 • n=12 Participants	336.21 10^3 cells/uL STANDARD_DEVIATION 93.88 • n=24 Participants
Glomerular Filtration Rate from Comprehensive Metabolic Panel	74.5 mL/min/1.73 m^2 STANDARD_DEVIATION 31.61 • n=12 Participants	61.25 mL/min/1.73 m^2 STANDARD_DEVIATION 37.59 • n=12 Participants	67.88 mL/min/1.73 m^2 STANDARD_DEVIATION 34.63 • n=24 Participants
Total Protein from Comprehensive Metabolic Panel	6.39 g/dL STANDARD_DEVIATION 0.69 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	6.45 g/dL STANDARD_DEVIATION 0.68 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	6.42 g/dL STANDARD_DEVIATION 0.67 • n=20 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Sodium for Comprehensive Metabolic Panel	138.92 mmol/L STANDARD_DEVIATION 3.15 • n=12 Participants	136.58 mmol/L STANDARD_DEVIATION 5.04 • n=12 Participants	137.75 mmol/L STANDARD_DEVIATION 4.28 • n=24 Participants
Potassium for Comprehensive Metabolic Panel	4.37 mmol/L STANDARD_DEVIATION 0.55 • n=12 Participants	4.52 mmol/L STANDARD_DEVIATION 0.67 • n=12 Participants	4.44 mmol/L STANDARD_DEVIATION 0.6 • n=24 Participants
Creatine for Comprehensive Metabolic Panel	1.18 mg/dL STANDARD_DEVIATION 0.77 • n=12 Participants	1.92 mg/dL STANDARD_DEVIATION 1.88 • n=12 Participants	1.55 mg/dL STANDARD_DEVIATION 1.46 • n=24 Participants
Glucose for Comprehensive Metabolic Panel	190.75 mg/dL STANDARD_DEVIATION 107.14 • n=12 Participants	193.67 mg/dL STANDARD_DEVIATION 85.44 • n=12 Participants	192.21 mg/dL STANDARD_DEVIATION 94.78 • n=24 Participants
Albumin for Comprehensive Metabolic Panel	3.22 g/dL STANDARD_DEVIATION 0.39 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	3.21 g/dL STANDARD_DEVIATION 0.51 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	3.22 g/dL STANDARD_DEVIATION 0.44 • n=20 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Alkaline Phosphatase for Comprehensive Metabolic Panel	90.9 U/L STANDARD_DEVIATION 59.3 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	96.5 U/L STANDARD_DEVIATION 52.69 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	93.7 U/L STANDARD_DEVIATION 54.67 • n=20 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Alanine Aminotransferase (ALT) or Serum Glutamic-pyruvic Transaminase (SGPT)	72.1 U/L STANDARD_DEVIATION 51.19 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	82.45 U/L STANDARD_DEVIATION 75.18 • n=11 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	77.52 U/L STANDARD_DEVIATION 63.51 • n=21 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT)	55.8 U/L STANDARD_DEVIATION 31.07 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	118.45 U/L STANDARD_DEVIATION 153.16 • n=11 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	88.62 U/L STANDARD_DEVIATION 114.86 • n=21 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Total Bilirubin for Comprehensive Metabolic Panel	0.62 mg/dL STANDARD_DEVIATION 0.39 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	0.65 mg/dL STANDARD_DEVIATION 0.25 • n=10 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.	0.64 mg/dL STANDARD_DEVIATION 0.32 • n=20 Participants • Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Blood Urea Nitrogen (BUN) for Comprehensive Metabolic Panel	29.58 mg/dL STANDARD_DEVIATION 16.61 • n=12 Participants	42.67 mg/dL STANDARD_DEVIATION 31.27 • n=12 Participants	36.13 mg/dL STANDARD_DEVIATION 25.38 • n=24 Participants
Calcium for Comprehensive Metabolic Panel	8.53 mg/dL STANDARD_DEVIATION 0.4 • n=12 Participants	8.32 mg/dL STANDARD_DEVIATION 0.87 • n=12 Participants	8.43 mg/dL STANDARD_DEVIATION 0.67 • n=24 Participants
Chloride Comprehensive Metabolic Panel	101 mmol/L STANDARD_DEVIATION 4.29 • n=12 Participants	100.5 mmol/L STANDARD_DEVIATION 6.33 • n=12 Participants	100.75 mmol/L STANDARD_DEVIATION 5.29 • n=24 Participants
Carbon Dioxide (CO2) for Comprehensive Metabolic Panel	24.42 mmol/L STANDARD_DEVIATION 3.99 • n=12 Participants	21.92 mmol/L STANDARD_DEVIATION 4.62 • n=12 Participants	23.17 mmol/L STANDARD_DEVIATION 4.41 • n=24 Participants
Oxygenation Index	8.09 Index STANDARD_DEVIATION 2.63 • n=4 Participants • Data missing. Oxidation Index is only measured and calculated in ventilated patients.	14.32 Index STANDARD_DEVIATION 14.68 • n=6 Participants • Data missing. Oxidation Index is only measured and calculated in ventilated patients.	11.83 Index STANDARD_DEVIATION 11.5 • n=10 Participants • Data missing. Oxidation Index is only measured and calculated in ventilated patients.
Positive End-Expiratory Pressure (PEEP)	13.75 cm H2O STANDARD_DEVIATION 2.06 • n=4 Participants • Data missing. PEEP is only measured in patients on ventilator.	12.71 cm H2O STANDARD_DEVIATION 2.14 • n=7 Participants • Data missing. PEEP is only measured in patients on ventilator.	13.09 cm H2O STANDARD_DEVIATION 2.07 • n=11 Participants • Data missing. PEEP is only measured in patients on ventilator.
Plateau Pressure	13.75 cm H2O STANDARD_DEVIATION 9.74 • n=4 Participants • Data missing. Plateau Pressure is only measured in patients on ventilator.	29 cm H2O STANDARD_DEVIATION 7.39 • n=4 Participants • Data missing. Plateau Pressure is only measured in patients on ventilator.	21.38 cm H2O STANDARD_DEVIATION 11.43 • n=8 Participants • Data missing. Plateau Pressure is only measured in patients on ventilator.
Sequential Organ Failure Assessment (SOFA) Score	5.5 score on a scale STANDARD_DEVIATION 2.61 • n=12 Participants • Data missing.	7.64 score on a scale STANDARD_DEVIATION 3.35 • n=11 Participants • Data missing.	6.52 score on a scale STANDARD_DEVIATION 3.12 • n=23 Participants • Data missing.
C-Reactive Protein (CRP)	97.97 mg/L STANDARD_DEVIATION 77.56 • n=12 Participants	144.35 mg/L STANDARD_DEVIATION 115.69 • n=12 Participants	121.16 mg/L STANDARD_DEVIATION 99.19 • n=24 Participants
D-Dimer	1.76 mcg/mL FEU STANDARD_DEVIATION 2.35 • n=12 Participants • data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest	4.96 mcg/mL FEU STANDARD_DEVIATION 6.04 • n=11 Participants • data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest	3.29 mcg/mL FEU STANDARD_DEVIATION 4.69 • n=23 Participants • data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio	45.38 ratio of AA to EPA STANDARD_DEVIATION 24.89 • n=12 Participants	45.79 ratio of AA to EPA STANDARD_DEVIATION 23.93 • n=12 Participants	45.58 ratio of AA to EPA STANDARD_DEVIATION 23.88 • n=24 Participants
25-OH vitamin D levels	21.76 ng/ml STANDARD_DEVIATION 8.48 • n=12 Participants	23.19 ng/ml STANDARD_DEVIATION 12.85 • n=12 Participants	22.47 ng/ml STANDARD_DEVIATION 10.68 • n=24 Participants
Respiratory Rate and Oxygenation Index (ROX)	7.36 Index STANDARD_DEVIATION 7.73 • n=8 Participants • data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores.	3.59 Index STANDARD_DEVIATION 1.13 • n=5 Participants • data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores.	5.91 Index STANDARD_DEVIATION 6.24 • n=13 Participants • data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores.
Viral Load by SARS-CoV-2 RT-PCR	352 copies n=12 Participants	3570.50 copies n=12 Participants	710 copies n=24 Participants
Panel Reactive Antibody (PRA) PRA Results Class I · Positive PRA	11 Participants n=12 Participants	9 Participants n=12 Participants	20 Participants n=24 Participants
Panel Reactive Antibody (PRA) PRA Results Class I · Negative PRA	1 Participants n=12 Participants	3 Participants n=12 Participants	4 Participants n=24 Participants
Panel Reactive Antibody (PRA) PRA Results Class II · Positive PRA	4 Participants n=12 Participants	6 Participants n=12 Participants	10 Participants n=24 Participants
Panel Reactive Antibody (PRA) PRA Results Class II · Negative PRA	8 Participants n=12 Participants	6 Participants n=12 Participants	14 Participants n=24 Participants
Serology (anti-SARS-CoV-2 IgM and IgG) IgM · Positive	4 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	5 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	9 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
Serology (anti-SARS-CoV-2 IgM and IgG) IgM · Negative	6 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	2 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	8 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
Serology (anti-SARS-CoV-2 IgM and IgG) IgM · Borderline	0 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	2 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	2 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
Serology (anti-SARS-CoV-2 IgM and IgG) IgG · Positive	5 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	8 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	13 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
Serology (anti-SARS-CoV-2 IgM and IgG) IgG · Negative	4 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	1 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	5 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
Serology (anti-SARS-CoV-2 IgM and IgG) IgG · Borderline	1 Participants n=10 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	0 Participants n=9 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.	1 Participants n=19 Participants • These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.

PRIMARY outcome

Timeframe: 6 and 24 hours

Population: In the UC-MSC treatment group, 4 participants were on mechanical ventilation and 8 participants were receiving high flow oxygen therapy. In the control group 7 participants were on mechanical ventilation and 5 participants were receiving high flow oxygen therapy.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Participants With Pre-Specified Infusion Associated Adverse Events Number of subjects with an increase in vasopressor dose at 6 h	1 Participants	1 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h	1 Participants	1 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h	0 Participants	0 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h	0 Participants	1 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h	0 Participants	1 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h	0 Participants	0 Participants
Number of Participants With Pre-Specified Infusion Associated Adverse Events Number of subjects with cardiac arrest or death within 24 h post infusion	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 31 days

The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Subjects With Serious Adverse Events by 31 Days After First Infusion	2 Participants	8 Participants

PRIMARY outcome

Timeframe: 90 days

Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90	41.67 percentage of participants	66.67 percentage of participants

PRIMARY outcome

Timeframe: 90 days

Total number of adverse events and serious adverse events as assessed by treating physician

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Adverse Events (not including SAEs)	40 Adverse Events	37 Adverse Events
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Serious Adverse Events	6 Adverse Events	16 Adverse Events

PRIMARY outcome

Timeframe: 90 days

Total number of adverse events plus serious adverse events categorized by severity.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity Mild	15 Adverse Events	13 Adverse Events
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity Moderate	22 Adverse Events	21 Adverse Events
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity Severe	9 Adverse Events	19 Adverse Events

PRIMARY outcome

Timeframe: 90 days

Population: Subjects who experience one or more AEs or SAEs within each category are counted only once.

Total number of subjects with adverse events and serious adverse events categorized by severity.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Subjects With Adverse Events and Serious Adverse Events by Severity Mild	7 Participants	5 Participants
Subjects With Adverse Events and Serious Adverse Events by Severity Moderate	7 Participants	8 Participants
Subjects With Adverse Events and Serious Adverse Events by Severity Severe	5 Participants	7 Participants

PRIMARY outcome

Timeframe: 90 days

Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment Unrelated	42 Adverse Events	45 Adverse Events
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment Unlikely	3 Adverse Events	7 Adverse Events
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment Possible	1 Adverse Events	1 Adverse Events
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment Probably	0 Adverse Events	0 Adverse Events
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment Definite	0 Adverse Events	0 Adverse Events

PRIMARY outcome

Timeframe: 90 days

Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Subjects With Adverse Events by Relatedness to Treatment Unrelated	8 Participants	10 Participants
Subjects With Adverse Events by Relatedness to Treatment Unlikely	1 Participants	4 Participants
Subjects With Adverse Events by Relatedness to Treatment Possible	1 Participants	1 Participants
Subjects With Adverse Events by Relatedness to Treatment Probable	0 Participants	0 Participants
Subjects With Adverse Events by Relatedness to Treatment Defininte	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 31 Days

Population: One subject in the UC-MSC Group was not included in the data analysis due to failed intubation.

Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=11 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Survival at 31 Days Post First Infusion	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 60 days

Population: A subject was censored due to failed intubation in the UC-MSC group.

Number of participants alive at 60 days post first infusion follow up.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=11 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Survival at 60 Days Post First Infusion	9 Participants	5 Participants

SECONDARY outcome

Timeframe: 31 days

Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Time to Recovery Days by which 75% of subjects were recovered	23 days Interval 13.0 to insufficient number of people recovered within 31 day limit to estimate the upper confidence	NA days insufficient number of people recovered within 31 day limit
Time to Recovery Days by which 50% of subjects were recovered	15 days Interval 6.0 to 23.0	NA days Interval 10.0 to insufficient number of people recovered within 31 day limit
Time to Recovery Days by which 25% of subjects were recovered	8 days Interval 3.0 to 15.0	12 days Interval 9.0 to insufficient number of people recovered within 31 day limit to estimate the upper confidence

SECONDARY outcome

Timeframe: 28 days post second infusion

Population: In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice.

Number of days participants were off ventilators during 28 days post second infusion.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Ventilator-Free Days Throughout 28 Days Post Second Infusion	28 days Interval 24.0 to 28.0	0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 90 days or hospital discharge, whichever is earlier

Number of days participants were off ventilators within up to 90 days of hospitalization.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Ventilator-Free Days Throughout 90 Days	90 days Interval 86.0 to 90.0	0 days Interval 0.0 to 90.0

SECONDARY outcome

Timeframe: day 6

Population: ROX index was only measured for patients receiving HFNC and/or not intubated patients. Three patients were ventilated in the UC-MSC group, one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, two patients data was not collected. In the control group one subject was not included in the analysis due to death before day 6, three patients were ventilated, and one patient data was not collected.

Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=7 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Respiratory Rate and Oxygenation Index (ROX Index)	9.57 Index Standard Deviation 5.23	7.44 Index Standard Deviation 2.9

SECONDARY outcome

Timeframe: day 6

Population: Oxidation Index is only measured and calculated in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.

Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 \* Mean airway pressure)/partial pressure of oxygen).

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=3 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=3 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Oxygenation Index (OI)	9.62 Index Standard Deviation 1.43	12.74 Index Standard Deviation 5.21

SECONDARY outcome

Timeframe: day 6

Population: PEEP and Plateau pressure are only measured in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.

Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=3 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=3 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) PEEP	9.73 cm H2O Standard Deviation 3.72	11.67 cm H2O Standard Deviation 1.53
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) Plateau Pressure	28.67 cm H2O Standard Deviation 9.61	24 cm H2O Standard Deviation 2.83

SECONDARY outcome

Timeframe: Day 6

Population: In the UC-MSC treatment group one subject was not included in the analysis due to death and 2 subjects were not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.

Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Sequential Organ Failure Assessment (SOFA) Scores	6.56 score on a scale Standard Deviation 2.7	6.82 score on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 90 days

Population: No participants in the study were able to complete the Smell Evaluation Test due to extenuating circumstances related to the COVID-19 pandemic.

SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 6

Population: The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.

As assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
White Blood Cell Count (WBC)	13.43 10^3 cells/uL Standard Deviation 4.62	15.53 10^3 cells/uL Standard Deviation 5.6

SECONDARY outcome

Timeframe: day 6

As assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Platelets Count	342 10^3 cells/uL Standard Deviation 136.33	397.89 10^3 cells/uL Standard Deviation 135.59

SECONDARY outcome

Timeframe: day 6

Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Hemogoblin	11.93 g/dL Standard Deviation 2.82	11.94 g/dL Standard Deviation 3.34

SECONDARY outcome

Timeframe: day 6

The percentage by volume of red cells in your blood as assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Hematocrit	37.98 percentage of red blood cells by volume Standard Deviation 8.32	36.73 percentage of red blood cells by volume Standard Deviation 9.56

SECONDARY outcome

Timeframe: day 6

Population: The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.

the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=8 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Neutrophils	9.74 10^3 cells/uL Standard Deviation 4.27	13.4 10^3 cells/uL Standard Deviation 5.95

SECONDARY outcome

Timeframe: day 6

Lymphocyte count as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=8 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Lymphocytes	1.38 10^3 cells/uL Standard Deviation 1.07	0.8 10^3 cells/uL Standard Deviation 0.41

SECONDARY outcome

Timeframe: day 6

Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Glomerular Filtration Rate	60.59 mL/min/1.73 m^2 Standard Deviation 26.99	68.67 mL/min/1.73 m^2 Standard Deviation 35.4

SECONDARY outcome

Timeframe: Day 6

Population: The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.

Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Total Protein	5.88 g/dL Standard Deviation 0.54	5.8 g/dL Standard Deviation 1.06

SECONDARY outcome

Timeframe: day 6

Sodium levels as assessed by serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Sodium	141.22 mmol/L Standard Deviation 6.24	141 mmol/L Standard Deviation 9.57

SECONDARY outcome

Timeframe: day 6

Potassium levels as assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Potassium	4.25 mmol/L Standard Deviation 0.71	4.37 mmol/L Standard Deviation 0.73

SECONDARY outcome

Timeframe: day 6

Creatinine levels as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Creatinine	1.21 mg/dL Standard Deviation 0.54	1.24 mg/dL Standard Deviation 0.74

SECONDARY outcome

Timeframe: day 6

Glucose levels as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Glucose	153.11 mg/dL Standard Deviation 63.99	183.89 mg/dL Standard Deviation 82.33

SECONDARY outcome

Timeframe: day 6

Albumin levels as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Albumin	2.96 g/dL Standard Deviation 0.43	2.73 g/dL Standard Deviation 0.45

SECONDARY outcome

Timeframe: day 6

Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Alkaline Phosphatase	136.2 U/L Standard Deviation 68.36	202.5 U/L Standard Deviation 219.13

SECONDARY outcome

Timeframe: day 6

The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)	64.4 U/L Standard Deviation 38.43	65.67 U/L Standard Deviation 45.04

SECONDARY outcome

Timeframe: day 6

The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)	55.8 U/L Standard Deviation 23.86	47 U/L Standard Deviation 32.47

SECONDARY outcome

Timeframe: day 6

Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=6 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Total Bilirubin	0.88 mg/dL Standard Deviation 0.46	0.77 mg/dL Standard Deviation 0.29

SECONDARY outcome

Timeframe: day 6

Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Blood Urea Nitrogen (BUN)	48 mg/dL Standard Deviation 22.28	47.67 mg/dL Standard Deviation 26.97

SECONDARY outcome

Timeframe: day 6

Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Calcium	8.5 mg/dL Standard Deviation 0.58	8.27 mg/dL Standard Deviation 0.67

SECONDARY outcome

Timeframe: day 6

Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Chloride	101.56 mmol/L Standard Deviation 7.63	102.44 mmol/L Standard Deviation 9.04

SECONDARY outcome

Timeframe: day 6

Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Carbon Dioxide (CO2)	28.44 mmol/L Standard Deviation 3.75	26.44 mmol/L Standard Deviation 4.61

SECONDARY outcome

Timeframe: day 6

Population: In the UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and data was missing for two subjects. In the control group one subject was not included in the analysis due to death before day 6.

As assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=8 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
C-Reactive Protein Levels	101.01 mg/L Standard Deviation 131.05	112.55 mg/L Standard Deviation 104.7

SECONDARY outcome

Timeframe: day 6

Population: The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.

As assessed via serum blood samples on day 6 (visit 8).

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio	33.6 ratio of AA to EPA Standard Deviation 12	34.64 ratio of AA to EPA Standard Deviation 13.24

SECONDARY outcome

Timeframe: day 6

As assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=9 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=10 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
D-dimer Levels	6.2 mcg/ml FEU Standard Deviation 11.29	4.69 mcg/ml FEU Standard Deviation 3.38

SECONDARY outcome

Timeframe: day 6

As assessed via serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
25-Hydroxy Vitamin D Levels	23.21 ng/ml Standard Deviation 8.91	27.58 ng/ml Standard Deviation 16.38

SECONDARY outcome

Timeframe: day 6

Population: In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw.

Analysis of TNFα in peripheral blood plasma

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=11 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Tumor Necrosis Factor-alpha (TNFα)	349 pg/mL Interval 228.0 to 407.0	451 pg/mL Interval 368.0 to 1730.0

SECONDARY outcome

Timeframe: day 6

Analysis of TNFβ in peripheral blood plasma

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=11 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Tumor Necrosis Factor-beta (TNFβ)	829 pg/mL Interval 494.0 to 1260.0	1540 pg/mL Interval 852.0 to 5890.0

SECONDARY outcome

Timeframe: day 6

Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=11 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=9 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)	26609.09 pg/mL Standard Deviation 3071.96	23111.11 pg/mL Standard Deviation 3086.03

SECONDARY outcome

Timeframe: day 6

Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Viral Load by SARS-CoV-2 RT-PCR	0 RNA copies/mL Interval 0.0 to 0.0	0 RNA copies/mL Interval 0.0 to 2193.0

SECONDARY outcome

Timeframe: day 3 post first infusion

Population: One subject in the control group died before day 3 post first infusion.

Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=12 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion Class I · PRA Positive	10 Participants	11 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion Class I · PRA Negative	2 Participants	0 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion Class II · PRA Positive	4 Participants	6 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion Class II · PRA Negative	8 Participants	5 Participants

SECONDARY outcome

Timeframe: day 6

Population: In the UC-MSC group one patient was censored and died before day 6 and one patient recovered before day 6 and left the hospital. In the control group on patient died before day 6 post first infusion.

Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=10 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=11 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion Class I · PRA Negative	1 Participants	2 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion Class II · PRA Positive	5 Participants	5 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion Class II · PRA Negative	5 Participants	6 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion Class I · PRA Positive	9 Participants	9 Participants

SECONDARY outcome

Timeframe: day 14

Population: In the UC-MSC group one patient was censored and died before day 6, 6 patients left the hospital before day 6 post first infusion. In the control group 4 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.

Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=5 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=4 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion Class I · PRA Positive	5 Participants	3 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion Class I · PRA Negative	0 Participants	1 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion Class II · PRA Positive	4 Participants	2 Participants
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion Class II · PRA Negative	1 Participants	2 Participants

SECONDARY outcome

Timeframe: day 14 post first infusion

Population: These analyses were implemented in a protocol version that did not apply to 2 patients of the UC-MSC treatment group and 3 patients of the control group. In the UC-MSC group one patient was censored and died before day 6, 4 patients left the hospital before day 6 post first infusion and in one patient blood was not drawn. In the control group 3 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.

Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.

Outcome measures

Outcome measures
Measure	UC-MSCs Group n=4 Participants Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=2 Participants Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgM · Positive	2 Participants	2 Participants
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgM · Negative	1 Participants	0 Participants
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgM · Borderline	1 Participants	0 Participants
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgG · Positive	4 Participants	2 Participants
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgG · Negative	0 Participants	0 Participants
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG IgG · Borderline	0 Participants	0 Participants

Adverse Events

UC-MSCs Group

Serious events: 5 serious events

Other events: 8 other events

Deaths: 3 deaths

Control Group

Serious events: 8 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	UC-MSCs Group n=12 participants at risk Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 participants at risk Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Gastrointestinal disorders GI Bleeding 2ry to Clostridium Difficile Infection	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Gastrointestinal disorders Colon Perforation	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Cardiac disorders Cardiact Arrest-Death due to Difficult Intubation	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Acute respiratory Failure 2ry to COVID-Death	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Cardiac disorders Atrial Flutter	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Psychiatric disorders Psychosis	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Cardiac disorders Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir	0.00% 0/12 • 3 months	25.0% 3/12 • Number of events 3 • 3 months
Respiratory, thoracic and mediastinal disorders Traumatic Tension Pneumotorax post-CPR	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Severe Respiratory Acidosis	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
General disorders [DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death	0.00% 0/12 • 3 months	16.7% 2/12 • Number of events 2 • 3 months
Cardiac disorders [DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death	8.3% 1/12 • Number of events 1 • 3 months	33.3% 4/12 • Number of events 4 • 3 months
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Metabolism and nutrition disorders Severe Metabolic Acidosis	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Infections and infestations Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months

Other adverse events

Other adverse events
Measure	UC-MSCs Group n=12 participants at risk Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\^6 cells/infusion administered intravenously in addition to the standard of care treatment.	Control Group n=12 participants at risk Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.
Cardiac disorders Atrial Fibrillation	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Cardiac disorders Bradycardia	8.3% 1/12 • Number of events 1 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Infections and infestations Exacerbation of COVID ARDS-Septic Shock	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Cardiac disorders Tachycardia	16.7% 2/12 • Number of events 2 • 3 months	0.00% 0/12 • 3 months
Cardiac disorders Tachycardia after infusion of Investigational Product	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Endocrine disorders Hyperglycemia	0.00% 0/12 • 3 months	16.7% 2/12 • Number of events 2 • 3 months
Gastrointestinal disorders Clostridium Difficile Infection	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Gastrointestinal disorders Mild Gastrointestinal Bleeding	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Hepatobiliary disorders Transaminitis/Transaminitis-Liver Shock	0.00% 0/12 • 3 months	16.7% 2/12 • Number of events 3 • 3 months
Hepatobiliary disorders Increased ALT, AST, and Alkaline Phosphatase	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Hepatobiliary disorders Increased Direct Bilirubin	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Renal and urinary disorders Abnormal Urinalysis	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Renal and urinary disorders Candiduria	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Blood and lymphatic system disorders Anemia	0.00% 0/12 • 3 months	16.7% 2/12 • Number of events 2 • 3 months
Blood and lymphatic system disorders Leukocytosis/Leukocytosis (Increased WBC)	25.0% 3/12 • Number of events 3 • 3 months	25.0% 3/12 • Number of events 3 • 3 months
Blood and lymphatic system disorders Severe Thrombocytopenia	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Blood and lymphatic system disorders Thrombocytopenia/Heparin-induced Thrombocytopenia	16.7% 2/12 • Number of events 2 • 3 months	0.00% 0/12 • 3 months
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Vascular disorders Bilateral Common Femoral Vein DVT	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Infections and infestations Candida Albicans Fungemia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
General disorders Fever	25.0% 3/12 • Number of events 3 • 3 months	16.7% 2/12 • Number of events 2 • 3 months
Metabolism and nutrition disorders Hypernatremia	16.7% 2/12 • Number of events 2 • 3 months	0.00% 0/12 • 3 months
Metabolism and nutrition disorders Mild Hyponatremia	8.3% 1/12 • Number of events 1 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Metabolism and nutrition disorders Hyperkalemia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Infections and infestations MRSA Bacteremia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Infections and infestations Paenebacillus Pabuli Bacteremia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Infections and infestations Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Infections and infestations Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Infections and infestations Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia	8.3% 1/12 • Number of events 1 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Musculoskeletal and connective tissue disorders Left Calf Collection	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Nervous system disorders Encephalopathy	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Nervous system disorders Dysconjugated gaze	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Renal and urinary disorders Urinary Tract Infection	8.3% 1/12 • Number of events 1 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Renal and urinary disorders Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK	16.7% 2/12 • Number of events 2 • 3 months	41.7% 5/12 • Number of events 5 • 3 months
Respiratory, thoracic and mediastinal disorders Pneumoperitoneum	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonitis, suspected	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Bradypnea	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Enterococcus Pneumonia	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders MRSA Hospital Acquired Pneumonia	16.7% 2/12 • Number of events 2 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v	8.3% 1/12 • Number of events 1 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Subcutaneous Emphysema	8.3% 1/12 • Number of events 1 • 3 months	0.00% 0/12 • 3 months
Respiratory, thoracic and mediastinal disorders Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa	0.00% 0/12 • 3 months	8.3% 1/12 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Worsening of Hypoxemia/Deterioration of Hypoxia	33.3% 4/12 • Number of events 4 • 3 months	0.00% 0/12 • 3 months

Additional Information

Camillo Ricordi

University of Miami

Phone: 305-243-6913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place