Trial Outcomes & Findings for Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (NCT NCT03818854)

Last Updated: 2025-12-04

Results Overview

Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

36 hours

Results posted on

2025-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Human Mesenchymal Stromal Cells A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Overall Study STARTED	59	61
Overall Study COMPLETED	59	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data are missing in 5 patients because patients/surrogates refused to release AIDS data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)	Total n=120 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=59 Participants	22 Participants n=61 Participants	43 Participants n=120 Participants
Age, Continuous	54.0 years STANDARD_DEVIATION 14.4 • n=59 Participants	57.0 years STANDARD_DEVIATION 15.1 • n=61 Participants	55.5 years STANDARD_DEVIATION 14.8 • n=120 Participants
Sex: Female, Male Female	20 Participants n=59 Participants	29 Participants n=61 Participants	49 Participants n=120 Participants
Sex: Female, Male Male	39 Participants n=59 Participants	32 Participants n=61 Participants	71 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=59 Participants	26 Participants n=61 Participants	47 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=59 Participants	31 Participants n=61 Participants	61 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=59 Participants	4 Participants n=61 Participants	12 Participants n=120 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=59 Participants	0 Participants n=61 Participants	1 Participants n=120 Participants
Race (NIH/OMB) Asian	9 Participants n=59 Participants	5 Participants n=61 Participants	14 Participants n=120 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=59 Participants	0 Participants n=61 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Black or African American	6 Participants n=59 Participants	2 Participants n=61 Participants	8 Participants n=120 Participants
Race (NIH/OMB) White	22 Participants n=59 Participants	32 Participants n=61 Participants	54 Participants n=120 Participants
Race (NIH/OMB) More than one race	0 Participants n=59 Participants	0 Participants n=61 Participants	0 Participants n=120 Participants
Region of Enrollment United States	59 participants n=59 Participants	61 participants n=61 Participants	120 participants n=120 Participants
COVID positive Yes	56 Participants n=59 Participants	45 Participants n=61 Participants	101 Participants n=120 Participants
COVID positive No	3 Participants n=59 Participants	16 Participants n=61 Participants	19 Participants n=120 Participants
Primary Cause of ARDS COVID-19 Pneumonia	56 Participants n=59 Participants	44 Participants n=61 Participants	100 Participants n=120 Participants
Primary Cause of ARDS Non COVID-19 Pneumonia	0 Participants n=59 Participants	5 Participants n=61 Participants	5 Participants n=120 Participants
Primary Cause of ARDS Sepsis	1 Participants n=59 Participants	3 Participants n=61 Participants	4 Participants n=120 Participants
Primary Cause of ARDS Trauma	2 Participants n=59 Participants	5 Participants n=61 Participants	7 Participants n=120 Participants
Primary Cause of ARDS Aspiration	0 Participants n=59 Participants	3 Participants n=61 Participants	3 Participants n=120 Participants
Primary Cause of ARDS Other	0 Participants n=59 Participants	1 Participants n=61 Participants	1 Participants n=120 Participants
Acute Physiology, Age, Chronic Health Evaluation (APACHE) III	100.8 units on a scale STANDARD_DEVIATION 26.0 • n=56 Participants • Data are missing in 5 patients because patients/surrogates refused to release AIDS data.	93.6 units on a scale STANDARD_DEVIATION 26.0 • n=59 Participants • Data are missing in 5 patients because patients/surrogates refused to release AIDS data.	97.1 units on a scale STANDARD_DEVIATION 26.1 • n=115 Participants • Data are missing in 5 patients because patients/surrogates refused to release AIDS data.
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Score	6.9 units on a scale STANDARD_DEVIATION 3.3 • n=59 Participants	6.5 units on a scale STANDARD_DEVIATION 2.6 • n=61 Participants	6.7 units on a scale STANDARD_DEVIATION 3.0 • n=120 Participants
Minute Ventilation	10.0 liter/min STANDARD_DEVIATION 2.8 • n=59 Participants	9.4 liter/min STANDARD_DEVIATION 2.4 • n=61 Participants	9.7 liter/min STANDARD_DEVIATION 2.6 • n=120 Participants
PaO2:FiO2	152 mmHg STANDARD_DEVIATION 44 • n=59 Participants	154 mmHg STANDARD_DEVIATION 39 • n=61 Participants	153 mmHg STANDARD_DEVIATION 42 • n=120 Participants
Lung Injury Score	3.2 units on a scale STANDARD_DEVIATION 0.4 • n=58 Participants • Data missing in one patient due to no quadrant value available for lung injury score calculation.	3.0 units on a scale STANDARD_DEVIATION 0.4 • n=61 Participants • Data missing in one patient due to no quadrant value available for lung injury score calculation.	3.1 units on a scale STANDARD_DEVIATION 0.4 • n=119 Participants • Data missing in one patient due to no quadrant value available for lung injury score calculation.
Oxygenation Index	13.6 cmH20/mmHg STANDARD_DEVIATION 6.6 • n=59 Participants • Data missing in one patient treated with Cell Reconstitution Media (Placebo) because the patient had pressure support ventilation (PSV), and the oxygenation index was not calculated.	12.1 cmH20/mmHg STANDARD_DEVIATION 4.4 • n=60 Participants • Data missing in one patient treated with Cell Reconstitution Media (Placebo) because the patient had pressure support ventilation (PSV), and the oxygenation index was not calculated.	12.8 cmH20/mmHg STANDARD_DEVIATION 5.6 • n=119 Participants • Data missing in one patient treated with Cell Reconstitution Media (Placebo) because the patient had pressure support ventilation (PSV), and the oxygenation index was not calculated.
Ventilatory Ratio	2.0 ratio STANDARD_DEVIATION 0.8 • n=59 Participants	1.9 ratio STANDARD_DEVIATION 0.6 • n=61 Participants	1.9 ratio STANDARD_DEVIATION 0.7 • n=120 Participants
Angiopoietin 2 (ANG-2)	3519 pg/mL n=43 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	3755 pg/mL n=45 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	3593 pg/mL n=88 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.
Interleukin 6 (IL-6)	56.3 pg/mL n=43 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	23.2 pg/mL n=45 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	37.1 pg/mL n=88 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.
Interleukin 8 (IL-8)	14.8 pg/mL n=43 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	12.8 pg/mL n=45 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	14.2 pg/mL n=88 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.
Receptor for Advanced Glycation Endproducts (RAGE)	5736 pg/mL n=43 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	6373 pg/mL n=45 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	6229 pg/mL n=88 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.
Tumor Necrosis Factor Receptor 1 (TNFR-1)	3492 pg/mL n=43 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	3919 pg/mL n=45 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	3758 pg/mL n=88 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.
Protein C	104.3 pg/mL n=42 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	99.7 pg/mL n=44 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.	102.2 pg/mL n=86 Participants • Some baseline samples were not obtained during the COVID-19 pandemic due to local institutional policies.

PRIMARY outcome

Timeframe: 36 hours

Population: Missing data are due to various causes: ventilated by PSV mode, not recorded, or expired.

Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Change in Oxygenation Index (OI) 36 Hour	0.8 cmH20/mmHg Interval -3.5 to 5.0	-1.5 cmH20/mmHg Interval -3.9 to 0.9
Change in Oxygenation Index (OI) 6 Hour	-0.7 cmH20/mmHg Interval -2.7 to 1.4	-1.5 cmH20/mmHg Interval -3.0 to 1.0
Change in Oxygenation Index (OI) 12 Hour	0.8 cmH20/mmHg Interval -1.6 to 3.5	-1.1 cmH20/mmHg Interval -3.9 to 0.9
Change in Oxygenation Index (OI) 18 Hour	0.3 cmH20/mmHg Interval -3.4 to 3.5	-1.0 cmH20/mmHg Interval -4.1 to 2.5
Change in Oxygenation Index (OI) 24 Hour	0.3 cmH20/mmHg Interval -3.7 to 5.9	-1.1 cmH20/mmHg Interval -4.2 to 2.2
Change in Oxygenation Index (OI) 30 Hour	0.8 cmH20/mmHg Interval -3.3 to 3.8	-0.7 cmH20/mmHg Interval -4.0 to 1.0

SECONDARY outcome

Timeframe: 7 days

Population: LIS were calculated for patients who were intubated.

Changes in the 4-point acute lung injury (LIS) score from the baseline to days 1, 2, 3 and 7, or on the last day of positive pressure ventilation prior to day 7. The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, lung compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Acute Lung Injury Score (LIS) Day 1	-0.10 score on a scale Standard Deviation 0.41	-0.10 score on a scale Standard Deviation 0.48
Acute Lung Injury Score (LIS) Day 2	-0.07 score on a scale Standard Deviation 0.41	-0.15 score on a scale Standard Deviation 0.62
Acute Lung Injury Score (LIS) Day 3	-0.15 score on a scale Standard Deviation 0.53	-0.09 score on a scale Standard Deviation 0.57
Acute Lung Injury Score (LIS) Day 7	-0.39 score on a scale Standard Deviation 0.69	-0.21 score on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: 7 days

Population: Due to the COVID-19 pandemic, the master majority of the enrolled patients had COVID-19, and it was not feasible to conduct the pulmonary dead space measurement because if would have increased the risk of spreading the COVID-19 virus to the health care workers, especially the respiratory therapists. Thus, this analysis is not available.

Pulmonary Dead Space at day 1, 2, 3 and 7. The dead-space fraction is calculated as: (PaCO2 - PeCO2) ÷ PaCO2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: RALE scores are calculated by the available Chest X-ray photographs.

Changes of RALE score at day 1, 2, 3 and 7 from baseline RALE score. To calculate RALE, each radiographic quadrant is scored for extent of consolidation (0-4) and density of opacification (1-3). The product of the consolidation and density scores for each of the four quadrants is summed. The RALE score ranges from 0 (best) to 48 (worst).

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score) Day 3	-0.5 score on a scale Interval -4.7 to 4.3	0.0 score on a scale Interval -3.4 to 4.0
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score) Day 7	-2.3 score on a scale Interval -9.3 to 5.7	2.4 score on a scale Interval -1.7 to 8.0
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score) Day 1	-0.7 score on a scale Interval -3.3 to 2.9	1.0 score on a scale Interval -2.5 to 5.0
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score) Day 2	-1.1 score on a scale Interval -5.8 to 4.3	1.7 score on a scale Interval -2.7 to 4.5

SECONDARY outcome

Timeframe: 14 days

Ventilator free-days over 14 days. Defined as the number of days from the time of initiating unassisted breathing to day 14 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 14. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 14, VFDs will be counted from the end of the last period of assisted breathing to day 14.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Ventilator Free-days (VFD) Over 14 Days 0 day	44 Participants	32 Participants
Ventilator Free-days (VFD) Over 14 Days 1 - 4 days	4 Participants	7 Participants
Ventilator Free-days (VFD) Over 14 Days 5 - 9 days	7 Participants	12 Participants
Ventilator Free-days (VFD) Over 14 Days 10 - 13 days	4 Participants	10 Participants

SECONDARY outcome

Timeframe: 28 days

Defined as the number of days from the time of initiating unassisted breathing to day 28 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Ventilator Free-days (VFD) Over 28 Days. 0 day	36 Participants	27 Participants
Ventilator Free-days (VFD) Over 28 Days. 1-9 days	6 Participants	4 Participants
Ventilator Free-days (VFD) Over 28 Days. 10-15 days	3 Participants	1 Participants
Ventilator Free-days (VFD) Over 28 Days. 15-19 days	6 Participants	12 Participants
Ventilator Free-days (VFD) Over 28 Days. 20-24 days	6 Participants	10 Participants
Ventilator Free-days (VFD) Over 28 Days. 25-27 days	2 Participants	7 Participants

SECONDARY outcome

Timeframe: 28 days

Population: The analysis was conducted in the subgroup of patients who survived by 6 months.

Duration of assisted ventilation over 28 days in the survivors

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=35 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=41 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Duration of Assisted Ventilation Over 28 Days	22 days Interval 9.0 to 28.0	10 days Interval 5.0 to 20.0

SECONDARY outcome

Timeframe: 28 days

Percentage of patients achieving pressure support ventilation equal to 5 cm H2O with positive end-expiratory pressure (PEEP) equal to 5 cm H2O for 2 hours

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours Yes	25 Participants	31 Participants
Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours No	34 Participants	30 Participants

SECONDARY outcome

Timeframe: 14 days

Superficial incisional/wound infections, deep incisional wound infections, and organ/space infections, and ventilator associated pneumonia (all during the 14 days after enrollment)

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Occurrence of Infection Ventilator associated pneumonia	20 Participants	14 Participants
Occurrence of Infection Organ/space infection	1 Participants	0 Participants
Occurrence of Infection Incisional/wound infection	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 days

Thromboembolic events are measured by ultrasound of the deep venous system or CT-angiography of the chest ordered for clinical purposes/by treating clinicians

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Occurrence of Thromboembolic Events	10 Participants	8 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Data were collected in the patients who were still in hospital alive.

SOFA score at 3 and 7 days. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 24 (worst).

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Sequential Organ Failure Assessment (SOFA) Over 7 Days Day 3	9.2 score on a scale Standard Deviation 3.1	8.6 score on a scale Standard Deviation 3.1
Sequential Organ Failure Assessment (SOFA) Over 7 Days Day 7	8.5 score on a scale Standard Deviation 3.8	7.7 score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: 7 days

Population: Data were collected in the patients who were still in hospital alive.

Non-pulmonary SOFA score at 3 and 7 days. The score is based on 5 different scores, one each for the cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 20 (worst).

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days Day 3	6.0 score on a scale Standard Deviation 3.2	5.5 score on a scale Standard Deviation 2.9
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days Day 7	5.6 score on a scale Standard Deviation 3.5	4.8 score on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: 60 days

Population: 4 patients were lost of followup up to 60 days.

All-cause mortality at 14, 28 and 60 days

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
All-cause Mortality 14-day mortality	12 Participants	8 Participants
All-cause Mortality 28-day mortality	16 Participants	15 Participants
All-cause Mortality 60-day mortality	21 Participants	18 Participants

SECONDARY outcome

Timeframe: 60 days

Population: 11 patients did not have recorded Glasgow Coma Scores at hospital discharge, all of them were expired.

Glasgow Outcome Score at hospital discharge. The GCS is a scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst)

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=53 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=56 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Glasgow Outcome Score (GCS)	10.6 score on a scale Standard Deviation 5.6	11.5 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 72 hours

Population: Plasma samples were not collected due to institutional policies during COVID-19 pandemic, or not available at the required timepoints (e.g. discharged from hospital or death).

Change in levels of plasma angiopoietin-2 from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Angiopoietin-2 6 hour	125 pg/mL Interval -807.0 to 1014.0	184 pg/mL Interval -99.0 to 635.0
Plasma Angiopoietin-2 24 hour	407 pg/mL Interval -1093.0 to 1733.0	288 pg/mL Interval -966.0 to 1895.0
Plasma Angiopoietin-2 48 hour	879 pg/mL Interval -200.0 to 2514.0	343 pg/mL Interval -2622.0 to 2035.0
Plasma Angiopoietin-2 72 hour	594 pg/mL Interval -1144.0 to 2318.0	544 pg/mL Interval -3359.0 to 2219.0

SECONDARY outcome

Timeframe: 72 hours

Population: Samples were not collected due to the intuitional policies regarding the biospecimen collection during COVID-19 pandemic, or not available at the required timepoint of collection (e.g. hospital discharge, death).

Change in levels of plasma RAGE from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Receptor for Advanced Glycation Endproducts (RAGE) 6 Hour	62 pg/mL Interval -839.0 to 954.0	-137 pg/mL Interval -1412.0 to 626.0
Plasma Receptor for Advanced Glycation Endproducts (RAGE) 24 Hour	-1249 pg/mL Interval -4152.0 to 598.0	100 pg/mL Interval -1712.0 to 2224.0
Plasma Receptor for Advanced Glycation Endproducts (RAGE) 48 Hour	-1603 pg/mL Interval -4710.0 to -338.0	-906 pg/mL Interval -3945.0 to 806.0
Plasma Receptor for Advanced Glycation Endproducts (RAGE) 72 Hour	-2619 pg/mL Interval -8478.0 to -993.0	-2054 pg/mL Interval -6275.0 to -198.0

SECONDARY outcome

Timeframe: 72 hours

Change in levels of plasma interleukin-6 from baseline compared to 6, 24, 48 and 72 hours

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Interleukin-6 (IL-6) 6 Hour	-10.1 pg/mL Interval -53.0 to 6.9	-3.3 pg/mL Interval -16.5 to 4.3
Plasma Interleukin-6 (IL-6) 24 Hour	-9.1 pg/mL Interval -60.9 to 19.2	5.2 pg/mL Interval -12.4 to 82.7
Plasma Interleukin-6 (IL-6) 48 Hour	-10.7 pg/mL Interval -66.2 to 31.6	4.1 pg/mL Interval -16.3 to 64.5
Plasma Interleukin-6 (IL-6) 72 Hour	-11.7 pg/mL Interval -90.3 to 56.6	2.8 pg/mL Interval -56.0 to 35.5

SECONDARY outcome

Timeframe: 72 hours

Change in levels of plasma interleukin-8 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Interleukin-8 (IL-8) 6 Hour	-1.0 pg/mL Interval -5.5 to 5.4	-0.4 pg/mL Interval -4.2 to 3.4
Plasma Interleukin-8 (IL-8) 24 Hour	-0.3 pg/mL Interval -9.0 to 6.8	0.3 pg/mL Interval -4.9 to 7.3
Plasma Interleukin-8 (IL-8) 48 Hour	-2.5 pg/mL Interval -4.9 to 4.7	-0.7 pg/mL Interval -5.9 to 3.7
Plasma Interleukin-8 (IL-8) 72 Hour	0.4 pg/mL Interval -4.1 to 4.9	1.4 pg/mL Interval -6.9 to 11.2

SECONDARY outcome

Timeframe: 72 hours

Change in levels of plasma TNFR-1 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1) 6 Hour	-1 pg/mL Interval -679.0 to 734.0	271 pg/mL Interval -345.0 to 1629.0
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1) 24 Hour	231 pg/mL Interval -422.0 to 2009.0	1047 pg/mL Interval 294.0 to 2730.0
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1) 48 Hour	721 pg/mL Interval -517.0 to 1756.0	1596 pg/mL Interval 354.0 to 5821.0
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1) 72 Hour	382 pg/mL Interval -40.0 to 1438.0	985 pg/mL Interval -137.0 to 2999.0

SECONDARY outcome

Timeframe: 72 hours

Change in levels of plasma protein C from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Protein C 6 Hour	7.3 pg/mL Interval -26.1 to 38.7	-2.9 pg/mL Interval -17.0 to 15.0
Plasma Protein C 24 Hour	8.5 pg/mL Interval -8.2 to 27.5	6.8 pg/mL Interval -27.6 to 30.3
Plasma Protein C 72 Hour	26.7 pg/mL Interval -15.3 to 55.6	8.3 pg/mL Interval -25.3 to 49.1
Plasma Protein C 48 Hour	14.0 pg/mL Interval -14.2 to 47.2	12.7 pg/mL Interval -19.7 to 38.2

SECONDARY outcome

Timeframe: 72 hours

Change in levels of plasma angiopoietin-1 from the baseline to 6, 24, 48 and 72 hours since the initiation of study product infusion.

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Plasma Angiopoietin-1 (ANG-1) 6 Hour	-224 pg/mL Interval -1548.0 to 1799.0	-292 pg/mL Interval -1366.0 to 1915.0
Plasma Angiopoietin-1 (ANG-1) 24 Hour	786 pg/mL Interval -8.0 to 3645.0	582 pg/mL Interval -1350.0 to 1827.0
Plasma Angiopoietin-1 (ANG-1) 48 Hour	612 pg/mL Interval -2033.0 to 3005.0	661 pg/mL Interval -881.0 to 3977.0
Plasma Angiopoietin-1 (ANG-1) 72 Hour	148 pg/mL Interval -2462.0 to 3950.0	59 pg/mL Interval -1646.0 to 2557.0

SECONDARY outcome

Timeframe: 24 hours

Tolerability of the hMSCs, defined as the incidence of pre-specified infusion-associated events and unexpected severe adverse events in ARDS patients treated with human MSCs

Outcome measures

Outcome measures
Measure	Human Mesenchymal Stromal Cells n=59 Participants A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 Participants A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events	2 Participants	2 Participants

Adverse Events

Human Mesenchymal Stromal Cells

Serious events: 3 serious events

Other events: 9 other events

Deaths: 24 deaths

Cell Reconstitution Media

Serious events: 2 serious events

Other events: 6 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Human Mesenchymal Stromal Cells n=59 participants at risk A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 participants at risk A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Cardiac disorders ECMO	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Blood and lymphatic system disorders Asymmetric perfusion	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Nervous system disorders Partial hemorrhage	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Respiratory, thoracic and mediastinal disorders Tension pneumothorax	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Cardiac disorders PEA arrest	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.

Other adverse events

Other adverse events
Measure	Human Mesenchymal Stromal Cells n=59 participants at risk A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes. Human Mesenchymal Stromal Cells: Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.	Cell Reconstitution Media n=61 participants at risk A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes. Cell Reconstitution Media: 300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Respiratory, thoracic and mediastinal disorders Agitation	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Cardiac disorders Arrhythmia	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Cardiac disorders Bradycardia	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Gastrointestinal disorders C, diff infection	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Nervous system disorders Diplopia	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Blood and lymphatic system disorders Sepsis	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Blood and lymphatic system disorders VAP Sepsis	3.4% 2/59 • Number of events 2 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.00% 0/59 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	1.6% 1/61 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Respiratory, thoracic and mediastinal disorders Decrease in oxygen saturation	1.7% 1/59 • Number of events 1 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	0.00% 0/61 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.
Nervous system disorders Deep Vein Thrombosis	5.1% 3/59 • Number of events 3 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.	3.3% 2/61 • Number of events 2 • Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.

Additional Information

Dr. Michael Matthay

University of California San Francisco

Phone: 415-476-1079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place