Respiratory failure & ventilation
Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT)
Authors' conclusion
This phase 2b clinical trial identified no physiologic or clinical benefit from a single dose of MSCs in patients with ARDS, including those with COVID-19 ARDS.
Study context
- Population
- Ventilated patients with acute respiratory distress syndrome (ARDS) (PaO2/FiO2 ratio <250 mm Hg); majority coronavirus disease (COVID-19) ARDS101 with COVID-19 ARDS
- Participants
- 120 patients
- Comparison
- Single dose of IV bone marrow-derived mesenchymal stromal cells (MSCs) vs placebo
- Primary endpoint
- Change in oxygenation index from baseline
- Follow-up
- 36 hours after baseline
Methodological detailsdouble-blind, placebo-controlled, multicentre, phase 2b, Enrollment began in January 2020; ARDS from COVID-19 in 101 of 120 (84%)
- Double-blind
- Placebo-controlled
- Multicentre
- Phase 2b
- Enrollment began in January 2020; ARDS from COVID-19 in 101 of 120 (84%)
Primary result
As reported in the abstract
- No differences in change in oxygenation index during the 36 h, entire cohort or COVID-19 subgroup
Further findings
Mortality · 14, 28, 60, or 180 days
- No significant differences in mortality
Plasma protein biomarker and gene expression analyses
- Subgroups of patients with differential treatment responses in clinical outcomes identified
Original publication
Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT). Am J Respir Crit Care Med. Published 29 July 2025. doi:10.
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