A Phase 2 interventional study of Human Mesenchymal Stromal Cells and Cell Reconstitution Media in Respiratory Distress Syndrome, Adult, sponsored by Michael A. Matthay. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Michael A. Matthay · Phase 2, Interventional, and Treatment
This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).
This clinical study design is a randomized, double-blinded, placebo-controlled Phase 2b clinical trial using a 10 million cell/kg dose of human Mesenchymal Stromal Cells (hMSCs). Subjects will be randomized in a 1:1 randomization scheme to receive hMSCs or cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) as the placebo; the study will enroll 120 patients who achieve a stable clinical baseline and receive study product (either hMSCs or the placebo).
The Data and Safety Monitoring Board (DSMB) will review adverse outcomes and protocol compliance. A pre-specified interim review will occur after 60 subjects have been enrolled and received study product; enrollment will continue during the DSMB review. All pre-specified clinically important events and unexpected serious adverse events including death during hospitalization up to 60 days will be reported to the DSMB on an ongoing basis; the study will be stopped for a safety evaluation by the DSMB if they have any concerns or if three subjects have pre-specified clinically important events or unexpected serious adverse events except death since death will be common in this critically ill population due the nature of the underlying illness (e.g., ARDS).
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Michael A. Matthay is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be eligible for inclusion if they meet all of the below criteria within 14 days of initial ICU admission. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:
Acute onset (defined below) of:
If the cause of ARDS is trauma, additional inclusion criteria will include ONE of the following relevant risk factors for developing ARDS:
Exclusion Criteria:
Severe traumatic brain injury - defined as:
A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes.
Biological: Human Mesenchymal Stromal Cells
A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes.
Biological: Cell Reconstitution Media
Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.
Also known as: hMSCs
300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
Also known as: Placebo
Change in Oxygenation Index (OI)
Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.
Time frame: 36 hours
Acute Lung Injury Score (LIS)
Changes in the 4-point acute lung injury (LIS) score from the baseline to days 1, 2, 3 and 7, or on the last day of positive pressure ventilation prior to day 7. The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, lung compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used.
Time frame: 7 days
Pulmonary Dead Space Fraction
Pulmonary Dead Space at day 1, 2, 3 and 7. The dead-space fraction is calculated as: (PaCO2 - PeCO2) ÷ PaCO2
Time frame: 7 days
Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score)
Changes of RALE score at day 1, 2, 3 and 7 from baseline RALE score. To calculate RALE, each radiographic quadrant is scored for extent of consolidation (0-4) and density of opacification (1-3). The product of the consolidation and density scores for each of the four quadrants is summed. The RALE score ranges from 0 (best) to 48 (worst).
Time frame: 7 days
Ventilator Free-days (VFD) Over 14 Days
Ventilator free-days over 14 days. Defined as the number of days from the time of initiating unassisted breathing to day 14 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 14. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 14, VFDs will be counted from the end of the last period of assisted breathing to day 14.
Time frame: 14 days
Ventilator Free-days (VFD) Over 28 Days.
Defined as the number of days from the time of initiating unassisted breathing to day 28 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28.
Time frame: 28 days
Duration of Assisted Ventilation Over 28 Days
Duration of assisted ventilation over 28 days in the survivors
Time frame: 28 days
Percentage of Patients Achieving Pressure Support Ventilation for 2 Hours
Percentage of patients achieving pressure support ventilation equal to 5 cm H2O with positive end-expiratory pressure (PEEP) equal to 5 cm H2O for 2 hours
Time frame: 28 days
Occurrence of Infection
Superficial incisional/wound infections, deep incisional wound infections, and organ/space infections, and ventilator associated pneumonia (all during the 14 days after enrollment)
Time frame: 14 days
Occurrence of Thromboembolic Events
Thromboembolic events are measured by ultrasound of the deep venous system or CT-angiography of the chest ordered for clinical purposes/by treating clinicians
Time frame: 60 days
Sequential Organ Failure Assessment (SOFA) Over 7 Days
SOFA score at 3 and 7 days. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 24 (worst).
Time frame: 7 days
Non-pulmonary Sequential Organ Failure Assessment (SOFA) Over 7 Days
Non-pulmonary SOFA score at 3 and 7 days. The score is based on 5 different scores, one each for the cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 20 (worst).
Time frame: 7 days
All-cause Mortality
All-cause mortality at 14, 28 and 60 days
Time frame: 60 days
Glasgow Outcome Score (GCS)
Glasgow Outcome Score at hospital discharge. The GCS is a scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst)
Time frame: 60 days
Plasma Angiopoietin-2
Change in levels of plasma angiopoietin-2 from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
Time frame: 72 hours
Plasma Receptor for Advanced Glycation Endproducts (RAGE)
Change in levels of plasma RAGE from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
Time frame: 72 hours
Plasma Interleukin-6 (IL-6)
Change in levels of plasma interleukin-6 from baseline compared to 6, 24, 48 and 72 hours
Time frame: 72 hours
Plasma Interleukin-8 (IL-8)
Change in levels of plasma interleukin-8 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Time frame: 72 hours
Plasma Tumor Necrosis Factor Receptor 1 (TNFR-1)
Change in levels of plasma TNFR-1 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Time frame: 72 hours
Plasma Protein C
Change in levels of plasma protein C from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Time frame: 72 hours
Plasma Angiopoietin-1 (ANG-1)
Change in levels of plasma angiopoietin-1 from the baseline to 6, 24, 48 and 72 hours since the initiation of study product infusion.
Time frame: 72 hours
Plasma Lipoxin A4
Change in levels of plasma lipoxin A4 from baseline compared to 6, 24, 48 and 72 hours
Time frame: 72 hours
Plasma Resolvin D1
Change in levels of plasma Resolvin D1 from baseline compared to 6, 24, 48 and 72 hours
Time frame: 72 hours
Plasma Keratinocyte Growth Factor (KGF)
Change in levels of plasma KGF from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
Time frame: 72 hours
Urine Microalbumin
Change in levels of urine microalbumin from baseline compared to 24 and 48 hours
Time frame: 48 hours
Total Protein in Min-bronchoalveolar Lavage (mBAL)
Change in total protein levels in from baseline to day 2
Time frame: 2 days
Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events
Tolerability of the hMSCs, defined as the incidence of pre-specified infusion-associated events and unexpected severe adverse events in ARDS patients treated with human MSCs
Time frame: 24 hours
| Milestone | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Started | 59 | 61 |
| Completed | 59 | 61 |
| Not completed | 0 | 0 |
Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.
| cmH20/mmHg | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | -0.7 (-2.7 to 1.4) | -1.5 (-3.0 to 1.0) |
| 12 Hour | 0.8 (-1.6 to 3.5) | -1.1 (-3.9 to 0.9) |
| 18 Hour | 0.3 (-3.4 to 3.5) | -1.0 (-4.1 to 2.5) |
| 24 Hour | 0.3 (-3.7 to 5.9) | -1.1 (-4.2 to 2.2) |
| 30 Hour | 0.8 (-3.3 to 3.8) | -0.7 (-4.0 to 1.0) |
| 36 Hour | 0.8 (-3.5 to 5.0) | -1.5 (-3.9 to 0.9) |
Changes in the 4-point acute lung injury (LIS) score from the baseline to days 1, 2, 3 and 7, or on the last day of positive pressure ventilation prior to day 7. The LIS is a composite 4-point scoring system including the PaO2/FiO2, PEEP, lung compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used.
| score on a scale | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Day 1 | -0.10 ± 0.41 | -0.10 ± 0.48 |
| Day 2 | -0.07 ± 0.41 | -0.15 ± 0.62 |
| Day 3 | -0.15 ± 0.53 | -0.09 ± 0.57 |
| Day 7 | -0.39 ± 0.69 | -0.21 ± 0.63 |
Pulmonary Dead Space at day 1, 2, 3 and 7. The dead-space fraction is calculated as: (PaCO2 - PeCO2) ÷ PaCO2
No measurements were reported for this outcome.
Changes of RALE score at day 1, 2, 3 and 7 from baseline RALE score. To calculate RALE, each radiographic quadrant is scored for extent of consolidation (0-4) and density of opacification (1-3). The product of the consolidation and density scores for each of the four quadrants is summed. The RALE score ranges from 0 (best) to 48 (worst).
| score on a scale | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Day 1 | -0.7 (-3.3 to 2.9) | 1.0 (-2.5 to 5.0) |
| Day 2 | -1.1 (-5.8 to 4.3) | 1.7 (-2.7 to 4.5) |
| Day 3 | -0.5 (-4.7 to 4.3) | 0.0 (-3.4 to 4.0) |
| Day 7 | -2.3 (-9.3 to 5.7) | 2.4 (-1.7 to 8.0) |
Ventilator free-days over 14 days. Defined as the number of days from the time of initiating unassisted breathing to day 14 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 14. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 14, VFDs will be counted from the end of the last period of assisted breathing to day 14.
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 0 day | 44 | 32 |
| 1 - 4 days | 4 | 7 |
| 5 - 9 days | 7 | 12 |
| 10 - 13 days | 4 | 10 |
Defined as the number of days from the time of initiating unassisted breathing to day 28 after study product administration, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28.
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 0 day | 36 | 27 |
| 1-9 days | 6 | 4 |
| 10-15 days | 3 | 1 |
| 15-19 days | 6 | 12 |
| 20-24 days | 6 | 10 |
| 25-27 days | 2 | 7 |
Duration of assisted ventilation over 28 days in the survivors
| days | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Duration of Assisted Ventilation Over 28 Days | 22 (9 to 28) | 10 (5 to 20) |
Percentage of patients achieving pressure support ventilation equal to 5 cm H2O with positive end-expiratory pressure (PEEP) equal to 5 cm H2O for 2 hours
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Yes | 25 | 31 |
| No | 34 | 30 |
Superficial incisional/wound infections, deep incisional wound infections, and organ/space infections, and ventilator associated pneumonia (all during the 14 days after enrollment)
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Incisional/wound infection | 3 | 1 |
| Organ/space infection | 1 | 0 |
| Ventilator associated pneumonia | 20 | 14 |
Thromboembolic events are measured by ultrasound of the deep venous system or CT-angiography of the chest ordered for clinical purposes/by treating clinicians
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Occurrence of Thromboembolic Events | 10 | 8 |
SOFA score at 3 and 7 days. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 24 (worst).
| score on a scale | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Day 3 | 9.2 ± 3.1 | 8.6 ± 3.1 |
| Day 7 | 8.5 ± 3.8 | 7.7 ± 4.8 |
Non-pulmonary SOFA score at 3 and 7 days. The score is based on 5 different scores, one each for the cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (best) to 20 (worst).
| score on a scale | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Day 3 | 6.0 ± 3.2 | 5.5 ± 2.9 |
| Day 7 | 5.6 ± 3.5 | 4.8 ± 3.8 |
All-cause mortality at 14, 28 and 60 days
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 14-day mortality | 12 | 8 |
| 28-day mortality | 16 | 15 |
| 60-day mortality | 21 | 18 |
Glasgow Outcome Score at hospital discharge. The GCS is a scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst)
| score on a scale | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Glasgow Outcome Score (GCS) | 10.6 ± 5.6 | 11.5 ± 5.3 |
Change in levels of plasma angiopoietin-2 from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 hour | 125 (-807 to 1014) | 184 (-99 to 635) |
| 24 hour | 407 (-1093 to 1733) | 288 (-966 to 1895) |
| 48 hour | 879 (-200 to 2514) | 343 (-2622 to 2035) |
| 72 hour | 594 (-1144 to 2318) | 544 (-3359 to 2219) |
Change in levels of plasma RAGE from baseline at 6, 24, 48 and 72 hours since the initiation of the study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | 62 (-839 to 954) | -137 (-1412 to 626) |
| 24 Hour | -1249 (-4152 to 598) | 100 (-1712 to 2224) |
| 48 Hour | -1603 (-4710 to -338) | -906 (-3945 to 806) |
| 72 Hour | -2619 (-8478 to -993) | -2054 (-6275 to -198) |
Change in levels of plasma interleukin-6 from baseline compared to 6, 24, 48 and 72 hours
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | -10.1 (-53.0 to 6.9) | -3.3 (-16.5 to 4.3) |
| 24 Hour | -9.1 (-60.9 to 19.2) | 5.2 (-12.4 to 82.7) |
| 48 Hour | -10.7 (-66.2 to 31.6) | 4.1 (-16.3 to 64.5) |
| 72 Hour | -11.7 (-90.3 to 56.6) | 2.8 (-56.0 to 35.5) |
Change in levels of plasma interleukin-8 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | -1.0 (-5.5 to 5.4) | -0.4 (-4.2 to 3.4) |
| 24 Hour | -0.3 (-9.0 to 6.8) | 0.3 (-4.9 to 7.3) |
| 48 Hour | -2.5 (-4.9 to 4.7) | -0.7 (-5.9 to 3.7) |
| 72 Hour | 0.4 (-4.1 to 4.9) | 1.4 (-6.9 to 11.2) |
Change in levels of plasma TNFR-1 from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | -1 (-679 to 734) | 271 (-345 to 1629) |
| 24 Hour | 231 (-422 to 2009) | 1047 (294 to 2730) |
| 48 Hour | 721 (-517 to 1756) | 1596 (354 to 5821) |
| 72 Hour | 382 (-40 to 1438) | 985 (-137 to 2999) |
Change in levels of plasma protein C from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | 7.3 (-26.1 to 38.7) | -2.9 (-17.0 to 15.0) |
| 24 Hour | 8.5 (-8.2 to 27.5) | 6.8 (-27.6 to 30.3) |
| 48 Hour | 14.0 (-14.2 to 47.2) | 12.7 (-19.7 to 38.2) |
| 72 Hour | 26.7 (-15.3 to 55.6) | 8.3 (-25.3 to 49.1) |
Change in levels of plasma angiopoietin-1 from the baseline to 6, 24, 48 and 72 hours since the initiation of study product infusion.
| pg/mL | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| 6 Hour | -224 (-1548 to 1799) | -292 (-1366 to 1915) |
| 24 Hour | 786 (-8 to 3645) | 582 (-1350 to 1827) |
| 48 Hour | 612 (-2033 to 3005) | 661 (-881 to 3977) |
| 72 Hour | 148 (-2462 to 3950) | 59 (-1646 to 2557) |
Change in levels of plasma lipoxin A4 from baseline compared to 6, 24, 48 and 72 hours
No measurements were reported for this outcome.
Change in levels of plasma Resolvin D1 from baseline compared to 6, 24, 48 and 72 hours
No measurements were reported for this outcome.
Change in levels of plasma KGF from baseline at 6, 24, 48 and 72 hours since the initiation of study product infusion.
No measurements were reported for this outcome.
Change in levels of urine microalbumin from baseline compared to 24 and 48 hours
No measurements were reported for this outcome.
Change in total protein levels in from baseline to day 2
No measurements were reported for this outcome.
Tolerability of the hMSCs, defined as the incidence of pre-specified infusion-associated events and unexpected severe adverse events in ARDS patients treated with human MSCs
| Participants | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Tolerability of the hMSCs - Incidence of Pre-specified Infusion-associated Events and Unexpected Severe Adverse Events | 2 | 2 |
Collected over Adverse event data was collected through 28 days from study product infusion. Death data was collected up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Mesenchymal Stromal Cells | 24/59 (40.7%) | 3/59 (5.1%) | 9/59 (15.3%) |
| Cell Reconstitution Media | 21/61 (34.4%) | 2/61 (3.3%) | 6/61 (9.8%) |
| Event | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| ECMOCardiac disorders | 1/59 | 0/61 |
| Tension pneumothoraxRespiratory, thoracic and mediastinal disorders | 1/59 | 0/61 |
| PEA arrestCardiac disorders | 1/59 | 0/61 |
| Asymmetric perfusionBlood and lymphatic system disorders | 0/59 | 1/61 |
| Partial hemorrhageNervous system disorders | 0/59 | 1/61 |
| Event | Human Mesenchymal Stromal Cells | Cell Reconstitution Media |
|---|---|---|
| Deep Vein ThrombosisNervous system disorders | 3/59 | 2/61 |
| VAP SepsisBlood and lymphatic system disorders | 2/59 | 1/61 |
| SepsisBlood and lymphatic system disorders | 1/59 | 0/61 |
| Decrease in oxygen saturationRespiratory, thoracic and mediastinal disorders | 1/59 | 0/61 |
| AgitationRespiratory, thoracic and mediastinal disorders | 1/59 | 0/61 |
| C, diff infectionGastrointestinal disorders | 1/59 | 0/61 |
| DiplopiaNervous system disorders | 1/59 | 0/61 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/59 | 1/61 |
| Aspiration pneumoniaRespiratory, thoracic and mediastinal disorders | 0/59 | 1/61 |
| ArrhythmiaCardiac disorders | 0/59 | 1/61 |
| Age, Continuous(years) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| Mean | 54.0 ± 14.4 | 57.0 ± 15.1 | 55.5 ± 14.8 |
| Sex: Female, Male(Participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| Female | 20 | 29 | 49 |
| Male | 39 | 32 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| Hispanic or Latino | 21 | 26 | 47 |
| Not Hispanic or Latino | 30 | 31 | 61 |
| Unknown or Not Reported | 8 | 4 | 12 |
| Race (NIH/OMB)(Participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 9 | 5 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 8 |
| White | 22 | 32 | 54 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 21 | 22 | 43 |
| Region of Enrollment(participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| United States | 59 | 61 | 120 |
| COVID positive(Participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| Yes | 56 | 45 | 101 |
| No | 3 | 16 | 19 |
| Primary Cause of ARDS(Participants) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| COVID-19 Pneumonia | 56 | 44 | 100 |
| Non COVID-19 Pneumonia | 0 | 5 | 5 |
| Sepsis | 1 | 3 | 4 |
| Trauma | 2 | 5 | 7 |
| Aspiration | 0 | 3 | 3 |
| Other | 0 | 1 | 1 |
| Acute Physiology, Age, Chronic Health Evaluation (APACHE) III(units on a scale) | Human Mesenchymal Stromal Cells | Cell Reconstitution Media | Total |
|---|---|---|---|
| Mean | 100.8 ± 26.0 | 93.6 ± 26.0 | 97.1 ± 26.1 |
12 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not have plan to share IPD data to other researchers.
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Respiratory Distress Syndrome→