Acute Respiratory Distress Syndrome, COVID-19, Sars-CoV2
Conditions
Keywords
Mesenchymal Stromal Cells, Respiratory failure
Brief summary
\*\*\*At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.\*\*\* This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs). Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells. The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Detailed description
Earlier, a healthy donor provided blood cells to generate MSCs. These cells were grown and frozen for later use. Before being treated, the patient will receive a series of standard medical tests: These tests are done to assess the patient's eligibility to receive the cells. * Physical exam and history * SARS-CoV-2 test * Blood tests * Chest X-ray or chest CT Scan * A urine pregnancy test, when applicable The patient will be randomly assigned to a study group. We'll use a computer to put the patient into study group A (study drug) or group B (control) by chance (randomized). Patients randomized to the control group, will receive the standard treatment for their respiratory infection. On the day that the patient is scheduled to receive the cells they will be pre-medicated with Benadryl and Tylenol. The patient will then receive an intravenous (into the vein) infusion of 1 x 10\^8 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion. The patient will receive a second infusion at the same dose within 3-5 days of the initial infusion (at the discretion of the investigator) if there is no improvement in respiratory parameters or if there is a worsening of Acute respiratory distress syndrome (ARDS). The patient will receive standard medical tests when getting the infusion(s) and afterwards. As part of the research study, the patient will be evaluated daily for 7 days and then weekly at weeks 2, 3, and 4. The evaluations that will be done at these visits include: * Physical exam and history * SARS-CoV-2 test * Blood tests * Chest X-ray or chest CT Scan
Interventions
BIOLOGICALMesenchymal 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.
OTHERSupportive Care
Patients will receive supportive care per their treating physician
Sponsors
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay 3. Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2): 1. Moderate ARDS: PaO2/FiO2 100-200 mmHg OR 2. Severe ARDS: PaO2/FiO2 ≤100 mmHg 4. If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O 5. Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
Exclusion criteria
1. Currently receiving extracorporeal membrane oxygenation (ECMO) 2. Severe chronic respiratory disease requiring use of home oxygen 3. Pregnant or lactating 4. Known hypersensitivity to dimethyl sulfoxide (DMSO) 5. Unstable hemodynamics as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion. 6. Uncontrolled bacterial or fungal co-infection 7. Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment 8. Inability to obtain informed consent (from patient or legally appropriate proxy) 9. Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin. 10. Respiratory failure not fully explained by cardiac failure or fluid overload.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) | 28 days post cell infusion | 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. |
| Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 | 14 days post cell infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oxygenation Free Days at Day 28 | 28 days post cell infusion | Number of oxygen support-free days through Day 28 |
| Number of Participants With Progression to Mechanical Ventilation or ECMO | 28 days post cell infusion | Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation. |
| Duration of Mechanical Ventilation and/or ECMO | 28 days post cell infusion | Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28) |
| Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 28 days post cell infusion | 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. |
| Duration of Hospital Stay | from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. Up to 35 days. | 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. |
| Overall Survival | 28 days post cell infusion | 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. |
| All-cause Mortality | 28 days post cell infusion | Number and percentage of deaths (all-cause) until Day 28 |
| Duration of ICU Stay | 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. | 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. |
| Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | 14 days post cell infusion | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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 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. | 10 |
| 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 | 12 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Safety Run In | Mesenchymal Stromal Cells (MSCs) | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 58.5 years | 56.5 years | 52.0 years | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 3 / 10 | 2 / 12 |
| other Total, other adverse events | 6 / 6 | 10 / 10 | 12 / 12 |
| serious Total, serious adverse events | 0 / 6 | 3 / 10 | 0 / 12 |
Outcome results
Primary
Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14
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.
Time frame: 14 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Run In | 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 |
| Safety Run In | 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 |
| Mesenchymal Stromal Cells | 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 |
| Mesenchymal Stromal Cells | 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 | 8 Participants |
| Control Group | 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 | 5 Participants |
| Control Group | 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 | 7 Participants |
Primary
Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs)
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.
Time frame: 28 days post cell infusion
Population: All participants who received MSCs are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Run In | Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) | 0 proportion of participant |
| Mesenchymal Stromal Cells | Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) | 0 proportion of participant |
Secondary
All-cause Mortality
Number and percentage of deaths (all-cause) until Day 28
Time frame: 28 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Safety Run In | All-cause Mortality | 0 Participants |
| Mesenchymal Stromal Cells | All-cause Mortality | 3 Participants |
| Control Group | All-cause Mortality | 2 Participants |
Secondary
Clinical Status Determined by 6-point Ordinal Scale at Day 28
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.
Time frame: 28 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 5=hospitalization, requiring ECOM and/or IMV | 0 Participants |
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 4=hospitalization, requiring NIV and/or HFNC therapy | 2 Participants |
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 1= hospital discharge | 3 Participants |
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 3=hospitalization, requiring supplemental oxygen | 1 Participants |
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 2=hospitalization, not requiring supplemental oxygen | 0 Participants |
| Safety Run In | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 6=dead | 0 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 1= hospital discharge | 4 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 2=hospitalization, not requiring supplemental oxygen | 0 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 3=hospitalization, requiring supplemental oxygen | 1 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 5=hospitalization, requiring ECOM and/or IMV | 2 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 6=dead | 3 Participants |
| Mesenchymal Stromal Cells | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 4=hospitalization, requiring NIV and/or HFNC therapy | 0 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 1= hospital discharge | 7 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 6=dead | 2 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 3=hospitalization, requiring supplemental oxygen | 2 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 4=hospitalization, requiring NIV and/or HFNC therapy | 0 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 5=hospitalization, requiring ECOM and/or IMV | 1 Participants |
| Control Group | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | 2=hospitalization, not requiring supplemental oxygen | 0 Participants |
Secondary
Duration of Hospital Stay
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run In | Duration of Hospital Stay | 24 days |
| Mesenchymal Stromal Cells | Duration of Hospital Stay | 24 days |
| Control Group | Duration of Hospital Stay | 17 days |
Secondary
Duration of ICU Stay
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run In | Duration of ICU Stay | 16 days |
| Mesenchymal Stromal Cells | Duration of ICU Stay | 19 days |
| Control Group | Duration of ICU Stay | 13 days |
Secondary
Duration of Mechanical Ventilation and/or ECMO
Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28)
Time frame: 28 days post cell infusion
Population: All participants are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run In | Duration of Mechanical Ventilation and/or ECMO | 0 days |
| Mesenchymal Stromal Cells | Duration of Mechanical Ventilation and/or ECMO | 11 days |
| Control Group | Duration of Mechanical Ventilation and/or ECMO | 1 days |
Secondary
Number of Oxygenation Free Days at Day 28
Number of oxygen support-free days through Day 28
Time frame: 28 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run In | Number of Oxygenation Free Days at Day 28 | 6 days |
| Mesenchymal Stromal Cells | Number of Oxygenation Free Days at Day 28 | 0 days |
| Control Group | Number of Oxygenation Free Days at Day 28 | 7 days |
Secondary
Number of Participants With Progression to Mechanical Ventilation or ECMO
Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation.
Time frame: 28 days post cell infusion
Population: Participants who were not receiving mechanical ventilation at baseline are included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Run In | Number of Participants With Progression to Mechanical Ventilation or ECMO | No progression to mechanical ventilation or ECMO | 4 Participants |
| Safety Run In | Number of Participants With Progression to Mechanical Ventilation or ECMO | Progression to mechanical ventilation or ECMO | 1 Participants |
| Mesenchymal Stromal Cells | Number of Participants With Progression to Mechanical Ventilation or ECMO | Progression to mechanical ventilation or ECMO | 6 Participants |
| Mesenchymal Stromal Cells | Number of Participants With Progression to Mechanical Ventilation or ECMO | No progression to mechanical ventilation or ECMO | 2 Participants |
| Control Group | Number of Participants With Progression to Mechanical Ventilation or ECMO | Progression to mechanical ventilation or ECMO | 3 Participants |
| Control Group | Number of Participants With Progression to Mechanical Ventilation or ECMO | No progression to mechanical ventilation or ECMO | 5 Participants |
Secondary
Overall Survival
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.
Time frame: 28 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Run In | Overall Survival | 1 probability of overall survival |
| Mesenchymal Stromal Cells | Overall Survival | 0.70 probability of overall survival |
| Control Group | Overall Survival | 0.825 probability of overall survival |
Secondary
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14
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).
Time frame: 14 days post cell infusion
Population: All study participants are included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Run In | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | No ARDS | 1 Participants |
| Safety Run In | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Mild | 2 Participants |
| Safety Run In | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Moderate | 2 Participants |
| Safety Run In | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Severe | 1 Participants |
| Mesenchymal Stromal Cells | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Mild | 1 Participants |
| Mesenchymal Stromal Cells | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Severe | 1 Participants |
| Mesenchymal Stromal Cells | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Moderate | 5 Participants |
| Mesenchymal Stromal Cells | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | No ARDS | 3 Participants |
| Control Group | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Moderate | 3 Participants |
| Control Group | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Mild | 2 Participants |
| Control Group | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | No ARDS | 4 Participants |
| Control Group | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | Severe | 3 Participants |