Trial Outcomes & Findings for Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease) (NCT NCT04345601)

Last Updated: 2024-10-09

Results Overview

Treatment-related serious adverse events (tSAE) are those directly related to the investigational infusion product. Adverse event grading will be per NCI Common Terminology Criteria for Adverse Events(CTCAE), vs 5. Rate of tSAEs in patients treated with MSCs will be reported as proportion and its 95% confidence interval.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

28 participants

Primary outcome timeframe

28 days post cell infusion

Results posted on

2024-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Run In The study will first enroll and treat six patients with mesenchymal stromal cells(MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells (MSCs) Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or acute respiratory distress syndrome (ARDS) clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells (MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Overall Study STARTED	6	10	12
Overall Study COMPLETED	6	7	8
Overall Study NOT COMPLETED	0	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Run In The study will first enroll and treat six patients with mesenchymal stromal cells(MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells (MSCs) Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or acute respiratory distress syndrome (ARDS) clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells (MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Overall Study Death	0	3	2
Overall Study Lost to Follow-up	0	0	2

Baseline Characteristics

Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with mesenchymal stromal cells (MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells (MSCs) n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician	Total n=28 Participants Total of all reporting groups
Age, Continuous	58.5 years n=5 Participants	56.5 years n=7 Participants	52.0 years n=5 Participants	55 years n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days post cell infusion

Population: All participants who received MSCs are included in the analysis.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs)	0 proportion of participant Interval 0.0 to 0.4593	0 proportion of participant Interval 0.0 to 0.3085	—

PRIMARY outcome

Timeframe: 14 days post cell infusion

Population: All study participants are included in the analysis.

Change by at least two categories on a six-category ordinal scale as improvement at day 14 post-randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 Improved by at least two categories	2 Participants	2 Participants	5 Participants
Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 Not improved by at least two categories	4 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: All study participants are included in the analysis.

Clinical status at day 28 as determined by 6-point ordinal scale as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Clinical Status Determined by 6-point Ordinal Scale at Day 28 1= hospital discharge	3 Participants	4 Participants	7 Participants
Clinical Status Determined by 6-point Ordinal Scale at Day 28 2=hospitalization, not requiring supplemental oxygen	0 Participants	0 Participants	0 Participants
Clinical Status Determined by 6-point Ordinal Scale at Day 28 3=hospitalization, requiring supplemental oxygen	1 Participants	1 Participants	2 Participants
Clinical Status Determined by 6-point Ordinal Scale at Day 28 4=hospitalization, requiring NIV and/or HFNC therapy	2 Participants	0 Participants	0 Participants
Clinical Status Determined by 6-point Ordinal Scale at Day 28 5=hospitalization, requiring ECOM and/or IMV	0 Participants	2 Participants	1 Participants
Clinical Status Determined by 6-point Ordinal Scale at Day 28 6=dead	0 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 14 days post cell infusion

Population: All study participants are included in the analysis.

ARDS is divided into 3 groups based on the degree of hypoxemia: mild (partial pressure of oxygen in the arterial blood(PaO2)/fraction of inspired oxygen(FIO2) 201-300 mm Hg), moderate (PaO2/FIO2: 101-200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and ventilator settings with a positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm water (H2O).

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 No ARDS	1 Participants	3 Participants	4 Participants
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 Mild	2 Participants	1 Participants	2 Participants
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 Moderate	2 Participants	5 Participants	3 Participants
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 Severe	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: All study participants are included in the analysis.

Number of oxygen support-free days through Day 28

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Number of Oxygenation Free Days at Day 28	6 days Interval 0.0 to 25.0	0 days Interval 0.0 to 21.0	7 days Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: Participants who were not receiving mechanical ventilation at baseline are included in the analysis.

Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation.

Outcome measures

Outcome measures
Measure	Safety Run In n=5 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=8 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=8 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Number of Participants With Progression to Mechanical Ventilation or ECMO Progression to mechanical ventilation or ECMO	1 Participants	6 Participants	3 Participants
Number of Participants With Progression to Mechanical Ventilation or ECMO No progression to mechanical ventilation or ECMO	4 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: All participants are included in the analysis.

Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28)

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Duration of Mechanical Ventilation and/or ECMO	0 days Interval 0.0 to 7.0	11 days Interval 0.0 to 28.0	1 days Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. Up to 35 days.

Population: Participants admitted to ICU are included in the analysis.

The number of days a participant spent in ICU. Duration of ICU stay is calculated from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=9 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=11 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Duration of ICU Stay	16 days Interval 4.0 to 29.0	19 days Interval 7.0 to 35.0	13 days Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. Up to 35 days.

Population: All study participants are included in the analysis.

Duration of hospital stay is calculated from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. It does not reflect the entire hospitalization time.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Duration of Hospital Stay	24 days Interval 4.0 to 34.0	24 days Interval 8.0 to 35.0	17 days Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: All study participants are included in the analysis.

Probability of overall survival is calculated using Kaplan-Meier survival curves per protocol. Overall survival time is defined as days from the date of randomization or date of infusion if received MSCs to the date of death or the date of the last follow-up for censoring.

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Overall Survival	1 probability of overall survival Interval 1.0 to 1.0	0.70 probability of overall survival Interval 0.329 to 0.892	0.825 probability of overall survival Interval 0.461 to 0.953

SECONDARY outcome

Timeframe: 28 days post cell infusion

Population: All study participants are included in the analysis.

Number and percentage of deaths (all-cause) until Day 28

Outcome measures

Outcome measures
Measure	Safety Run In n=6 Participants The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells n=10 Participants Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells: Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 Participants Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
All-cause Mortality	0 Participants	3 Participants	2 Participants

Adverse Events

Safety Run In

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Mesenchymal Stromal Cells (MSCs)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 3 deaths

Control Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Safety Run In n=6 participants at risk The study will first enroll and treat six patients with mesenchymal stromal cells (MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Mesenchymal Stromal Cells (MSCs) n=10 participants at risk Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10\^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.	Control Group n=12 participants at risk Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician
Cardiac disorders Cardiac arrest	0.00% 0/6 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	10.0% 1/10 • Number of events 1 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	0.00% 0/12 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	20.0% 2/10 • Number of events 2 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	0.00% 0/12 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	10.0% 1/10 • Number of events 1 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.	0.00% 0/12 • 28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first. Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.

Other adverse events

Additional Information

Dr. Laquisa Hill

Baylor College of Medicine

Phone: 713-441-1450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place