Trial Outcomes & Findings for Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START) (NCT NCT02097641)
NCT ID: NCT02097641
Last Updated: 2019-04-10
Results Overview
Within 6 h of study product infusion: * Increase in vasopressor dose to the following values or higher: * Norepinephrine 10 μg/min * Phenylephrine 100 μg/min * Dopamine 10 μg/kg per min * Epinephrine 0.1 μg/kg per min or addition of a third vasopressor * New ventricular tachycardia, ventricular fibrillation or asystole * New cardiac arrhythmia requiring cardioversion * Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95% * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
6 hours
Results posted on
2019-04-10
Participant Flow
From March 24, 2014, to Feb 9, 2017, 1038 patients were screened for eligibility, of whom 975 were excluded, and 63 were randomly assigned to a treatment group. Three patients were not eligible for treatment after randomization and, therefore, 40 patients received human mesenchymal stem cells and 20 patients received placebo.
Three patients who were randomly assigned to receive human mesenchymal stem cells, were excluded: 2 did not meet baseline stability criteria; 1 patient's PaO2:FiO2 \> 200 mmHg.
Participant milestones
| Measure |
Human Mesenchymal Stem Cells
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not recorded in one patient treated with Plasma-Lyte A (placebo).
Baseline characteristics by cohort
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=40 Participants
|
12 Participants
n=20 Participants
|
42 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=40 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=60 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 17 • n=40 Participants
|
55 years
STANDARD_DEVIATION 20 • n=20 Participants
|
55 years
STANDARD_DEVIATION 18 • n=60 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=40 Participants
|
10 Participants
n=20 Participants
|
33 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=40 Participants
|
10 Participants
n=20 Participants
|
27 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=40 Participants
|
16 Participants
n=20 Participants
|
47 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=40 Participants
|
13 Participants
n=20 Participants
|
40 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
20 participants
n=20 Participants
|
60 participants
n=60 Participants
|
|
Cause of Acute Respiratory Distress Syndrome (ARDS)
Sepsis with pneumonia
|
19 Participants
n=40 Participants
|
12 Participants
n=20 Participants
|
31 Participants
n=60 Participants
|
|
Cause of Acute Respiratory Distress Syndrome (ARDS)
Sepsis without pneumonia
|
5 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=60 Participants
|
|
Cause of Acute Respiratory Distress Syndrome (ARDS)
Pneumonia without sepsis
|
11 Participants
n=40 Participants
|
5 Participants
n=20 Participants
|
16 Participants
n=60 Participants
|
|
Cause of Acute Respiratory Distress Syndrome (ARDS)
Aspiration only
|
4 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=60 Participants
|
|
Cause of Acute Respiratory Distress Syndrome (ARDS)
Other
|
1 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Arterial pressure
|
75 mm Hg
STANDARD_DEVIATION 10 • n=40 Participants
|
76 mm Hg
STANDARD_DEVIATION 9 • n=20 Participants
|
75 mm Hg
STANDARD_DEVIATION 10 • n=60 Participants
|
|
Taking vasopressors at the time of infusion
|
24 Participants
n=40 Participants
|
9 Participants
n=20 Participants
|
33 Participants
n=60 Participants
|
|
Sequential Organ Failure Assessment (SOFA)
|
8.1 units on a scale
STANDARD_DEVIATION 3.3 • n=40 Participants • Data not recorded in one patient treated with Plasma-Lyte A (placebo).
|
6.9 units on a scale
STANDARD_DEVIATION 2.7 • n=19 Participants • Data not recorded in one patient treated with Plasma-Lyte A (placebo).
|
7.7 units on a scale
STANDARD_DEVIATION 3.2 • n=59 Participants • Data not recorded in one patient treated with Plasma-Lyte A (placebo).
|
|
Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) III score
|
104 units on a scale
STANDARD_DEVIATION 31 • n=40 Participants • Data not recorded in one patient treated with Plasma-Lyte (placebo).
|
89 units on a scale
STANDARD_DEVIATION 33 • n=19 Participants • Data not recorded in one patient treated with Plasma-Lyte (placebo).
|
99 units on a scale
STANDARD_DEVIATION 32 • n=59 Participants • Data not recorded in one patient treated with Plasma-Lyte (placebo).
|
|
Minute ventilation
|
11.1 L/min
STANDARD_DEVIATION 3.2 • n=40 Participants
|
9.6 L/min
STANDARD_DEVIATION 2.4 • n=20 Participants
|
10.6 L/min
STANDARD_DEVIATION 3.0 • n=60 Participants
|
|
Respiratory rate
|
27.8 breaths/min
STANDARD_DEVIATION 6.6 • n=40 Participants
|
24.5 breaths/min
STANDARD_DEVIATION 6.3 • n=20 Participants
|
26.7 breaths/min
STANDARD_DEVIATION 6.6 • n=60 Participants
|
|
Tidal volume
|
6.3 mL/kg predicted body weight
STANDARD_DEVIATION 0.9 • n=39 Participants • Data not recorded in one patient treated with hMSCs.
|
6.1 mL/kg predicted body weight
STANDARD_DEVIATION 0.7 • n=20 Participants • Data not recorded in one patient treated with hMSCs.
|
6.2 mL/kg predicted body weight
STANDARD_DEVIATION 0.9 • n=59 Participants • Data not recorded in one patient treated with hMSCs.
|
|
Mean airway pressure
|
17.8 cm H2O
STANDARD_DEVIATION 4.9 • n=37 Participants • Data not recorded in three patients treated with hMSCs and one patient treated with Plasma-Lyte A (placebo).
|
16.4 cm H2O
STANDARD_DEVIATION 3.6 • n=19 Participants • Data not recorded in three patients treated with hMSCs and one patient treated with Plasma-Lyte A (placebo).
|
17.4 cm H2O
STANDARD_DEVIATION 4.6 • n=56 Participants • Data not recorded in three patients treated with hMSCs and one patient treated with Plasma-Lyte A (placebo).
|
|
Plateau airway pressure
|
26.4 cm H2O
STANDARD_DEVIATION 5.7 • n=30 Participants • 15 patients did not have baseline plateau pressure recorded.
|
23.7 cm H2O
STANDARD_DEVIATION 5.1 • n=15 Participants • 15 patients did not have baseline plateau pressure recorded.
|
25.5 cm H2O
STANDARD_DEVIATION 5.6 • n=45 Participants • 15 patients did not have baseline plateau pressure recorded.
|
|
Positive end-expiratory pressure (PEEP)
|
12.4 cm H2O
STANDARD_DEVIATION 3.7 • n=40 Participants
|
10.8 cm H2O
STANDARD_DEVIATION 2.6 • n=20 Participants
|
11.8 cm H2O
STANDARD_DEVIATION 3.4 • n=60 Participants
|
|
Driving pressure
|
14.0 cm H2O
STANDARD_DEVIATION 4.1 • n=30 Participants • Data not recorded in 10 patients treated with hMSCs and in 5 patients treated with Plasma-Lyte (placebo).
|
12.5 cm H2O
STANDARD_DEVIATION 4.3 • n=15 Participants • Data not recorded in 10 patients treated with hMSCs and in 5 patients treated with Plasma-Lyte (placebo).
|
13.5 cm H2O
STANDARD_DEVIATION 4.2 • n=45 Participants • Data not recorded in 10 patients treated with hMSCs and in 5 patients treated with Plasma-Lyte (placebo).
|
|
PaO2/FiO2
|
18.1 kPa
STANDARD_DEVIATION 4.3 • n=40 Participants
|
19.1 kPa
STANDARD_DEVIATION 5.2 • n=20 Participants
|
18.4 kPa
STANDARD_DEVIATION 4.6 • n=60 Participants
|
|
Oxygenation index
|
108.1 kPa
STANDARD_DEVIATION 45.9 • n=37 Participants • Data not recorded in 3 patients treated with hMSCs and 1 patient treated with Plasma-Lyte (placebo).
|
95.7 kPa
STANDARD_DEVIATION 41.2 • n=19 Participants • Data not recorded in 3 patients treated with hMSCs and 1 patient treated with Plasma-Lyte (placebo).
|
103.9 kPa
STANDARD_DEVIATION 44.4 • n=56 Participants • Data not recorded in 3 patients treated with hMSCs and 1 patient treated with Plasma-Lyte (placebo).
|
|
Lung injury score (LIS)
|
3.1 units on a scale
STANDARD_DEVIATION 0.4 • n=40 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.5 • n=20 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.4 • n=60 Participants
|
|
Ventilation mode
Volume control
|
37 Participants
n=40 Participants
|
17 Participants
n=20 Participants
|
54 Participants
n=60 Participants
|
|
Ventilation mode
Pressure-regulated volume control
|
1 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
|
Ventilation mode
Other
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 6 hoursWithin 6 h of study product infusion: * Increase in vasopressor dose to the following values or higher: * Norepinephrine 10 μg/min * Phenylephrine 100 μg/min * Dopamine 10 μg/kg per min * Epinephrine 0.1 μg/kg per min or addition of a third vasopressor * New ventricular tachycardia, ventricular fibrillation or asystole * New cardiac arrhythmia requiring cardioversion * Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95% * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 hoursWithin 24 h of study product infusion • Any cardiac arrest or death
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSafety endpoint: Any unexpected severe adverse events in two groups
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
|
20 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline and day 3Population: The values of PaO2:FiO2 were not available in 10 patients treated with hMSCs and in 2 patients treated with placebo.
Efficacy endpoint: PaO2:FiO2 change from baseline to day 3
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=30 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
PaO2:FiO2 Change From Baseline to Day 3
|
3.7 kPa
Interval -1.2 to 10.8
|
3.5 kPa
Interval -2.7 to 8.3
|
SECONDARY outcome
Timeframe: baseline and day 3Population: The values were missing in 9 hMSC patients and 2 placebo patients.
Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome.
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=31 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Lung Injury Score From Baseline to Day 3
|
-0.50 units on a scale
Interval -1.0 to -0.25
|
-0.33 units on a scale
Interval -0.67 to -0.08
|
SECONDARY outcome
Timeframe: baseline and day 2Population: The values were missing in 16 patients treated by MSC and 6 patients treated by placebo
Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=24 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=14 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Oxygenation Index Change From Baseline to Day 2
|
-30.3 kPa
Interval -67.9 to 14.9
|
-19.5 kPa
Interval -47.8 to 10.9
|
SECONDARY outcome
Timeframe: baseline and day 3Population: The values were missing in 3 MSC patients and 1 placebo patient.
Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse.
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=37 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=19 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
SOFA Score Change From Baseline to Day 3
|
-2 units on a scale
Interval -4.0 to 0.0
|
-1 units on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: 28 daysEfficacy endpoint: all-cause mortality at day 28
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Number of Patients Death to Day 28
|
12 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 60 daysEfficacy endpoint: all-cause mortality at day 60
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Mortality to Day 60
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 28 daysEfficacy endpoint: Number of ventilator-free days to day 28.
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Number of Ventilator-free Days to Day 28
|
2 days
Interval 0.0 to 23.0
|
17 days
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: 28 daysEfficacy endpoint: Non-pulmonary organ-failure-free days to day 28
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=40 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=20 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Non-pulmonary Organ-failure-free Days to Day 28
|
12 days
Interval 4.0 to 24.0
|
8 days
Interval 4.0 to 15.0
|
SECONDARY outcome
Timeframe: baseline and 6 hoursPopulation: The biomarker values were missing in one patient treated with hMSC and one patient treated with placebo.
Biological markers of endothelial injury: angiopoietin 2
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=39 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=19 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Angiopoietin 2 Change From Baseline to 6 h
|
-1120 pg/mL
Interval -4706.0 to -66.0
|
287 pg/mL
Interval -1005.0 to 2374.0
|
SECONDARY outcome
Timeframe: baseline and 24 hoursPopulation: The values were not available in two patients treated with hMSC and two patients treated with placebo.
Biological markers of endothelial injury: angiopoietin 2
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=38 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Angiopoietin 2 Change From Baseline to 24 h
|
-2080 pg/mL
Interval -6404.0 to 47.0
|
-537 pg/mL
Interval -4294.0 to 1029.0
|
SECONDARY outcome
Timeframe: baseline and 6 hoursPopulation: The values were not available in one patient treated with hMSC and one patient treated with placebo.
Biological markers of inflammation: interleukin 6
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=39 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=19 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Interleukin 6 Change From Baseline to 6 h
|
-51 pg/mL
Interval -124.0 to 4.0
|
-20 pg/mL
Interval -71.0 to 17.0
|
SECONDARY outcome
Timeframe: baseline and 24 hoursPopulation: The values were not available in two patients treated with hMSC and two patients treated with placebo.
Biological markers of inflammation: interleukin 6
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=38 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Interleukin 6 Change From Baseline to 24 h
|
-34 pg/mL
Interval -137.0 to 4.0
|
-43 pg/mL
Interval -165.0 to 39.0
|
SECONDARY outcome
Timeframe: baseline and 6 hoursPopulation: The values were not available in one patient treated with hMSC and one patient treated with placebo.
Biological markers of inflammation: interleukin 8
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=39 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=19 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Interleukin 8 Change From Baseline to 6 h
|
-2 pg/mL
Interval -24.0 to 3.0
|
-1 pg/mL
Interval -8.0 to 1.0
|
SECONDARY outcome
Timeframe: baseline and 24 hoursPopulation: The values were not available in two patients treated with hMSC and two patients treated with placebo.
Biological markers of inflammation: interleukin 8
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=38 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Interleukin 8 Change From Baseline to 24 h
|
-5 pg/mL
Interval -34.0 to 4.0
|
-5 pg/mL
Interval -17.0 to -1.0
|
SECONDARY outcome
Timeframe: baseline and 6 hoursPopulation: The values were not available in one patient treated with hMSC and one patient treated with placebo.
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=39 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=19 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
RAGE Change From Baseline to 6 h
|
-326 pg/mL
Interval -888.0 to -45.0
|
-322 pg/mL
Interval -624.0 to -93.0
|
SECONDARY outcome
Timeframe: baseline and 24 hoursPopulation: The values were not available in two patients treated with hMSC and two patients treated with placebo.
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Outcome measures
| Measure |
Human Mesenchymal Stem Cells (hMSCs)
n=38 Participants
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A (Placebo)
n=18 Participants
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
RAGE Change From Baseline to 24 h
|
-393 pg/mL
Interval -1118.0 to -78.0
|
-411 pg/mL
Interval -1057.0 to -110.0
|
Adverse Events
Human Mesenchymal Stem Cells
Serious events: 17 serious events
Other events: 2 other events
Deaths: 15 deaths
Plasma-Lyte A
Serious events: 11 serious events
Other events: 2 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Human Mesenchymal Stem Cells
n=40 participants at risk
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A
n=20 participants at risk
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Nervous system disorders
Lower extremity weakness
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Surgical and medical procedures
Hospital readmission due to post-surgical pain
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Renal and urinary disorders
Acute renal failure
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Renal and urinary disorders
Hospital readmission due to pyelonephritis
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Blood and lymphatic system disorders
Acute leukemia
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Blood and lymphatic system disorders
Diffuse alveolar hemorrhage
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Death due to cardiac arrest
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Myocardial ischemia
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Bradycardia
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Tachycardia
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Heart block
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Cardiac disorders
Ischemic stroke
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Hepatobiliary disorders
Liver abscess
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Hepatobiliary disorders
Acute pancreatitis
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Respiratory, thoracic and mediastinal disorders
Death due to worsening respiratory failure
|
7.5%
3/40 • Number of events 3 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Respiratory, thoracic and mediastinal disorders
Worsening respiratory failure, recovered
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Blood and lymphatic system disorders
Calvarial bone marrow abnormality
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
10.0%
2/20 • Number of events 2 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
General disorders
Death due to multi-organ failure
|
20.0%
8/40 • Number of events 8 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
10.0%
2/20 • Number of events 2 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
Other adverse events
| Measure |
Human Mesenchymal Stem Cells
n=40 participants at risk
A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells administered intravenously over approximately 60-80 minutes.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously over approximately 60-80 minutes.
|
Plasma-Lyte A
n=20 participants at risk
A single dose of Plasma-Lyte A will be administered intravenously over approximately 60-80 minutes.
Plasma-Lyte A: Plasma-Lyte A placebo will be administered intravenously over approximately 60-80 minutes.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
1/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Renal and urinary disorders
Fecal and urinary incontinence
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Vascular disorders
Deep venous thrombosis
|
2.5%
1/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
0.00%
0/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
|
Blood and lymphatic system disorders
Acute anemia
|
0.00%
0/40 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
5.0%
1/20 • 60 days
1. All-cause mortality by day 60 after study product infusion 2. Serious adverse events, expected and unexpected, also included any deaths through study day 28 (none of them were related to study product or study procedures per DSMB review) 3. Please see our Lancet Resp Medicine 2018 publication (citation included) for further details including adjusted analyses of baseline differences between the MSC and placebo treated groups
|
Additional Information
Michael A. Matthay, MD
University of California San Francisco
Phone: 415-502-7434
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place