Respiratory failure & ventilation
Bone Marrow Mesenchymal Stem Cell-Derived Extracellular Vesicle Infusion for the Treatment of Respiratory Failure From COVID-19: A Randomized, Placebo-Controlled Dosing Clinical Trial
An erratum to this article was published (Chest, Jul 2024 ↗)
Authors' conclusion
The 15 mL dose of ExoFlo was found to be safe in patients with severe or critical COVID-19-associated respiratory failure.
Study context
- Population
- Patients with COVID-19-associated moderate to severe ARDS, 5 US sites
- Participants
- 102 patients · 5 sites
- Comparison
- ExoFlo 10 mL or 15 mL vs placebo, infused on days 1 and 4
- Primary endpoint
- All-cause mortality rate
- Follow-up
- 60 days
Methodological detailsphase 2, multicentre, double-anonymized, placebo-controlled, dosing trial
- Phase 2
- Multicentre
- Double-anonymized
- Placebo-controlled
- Dosing trial
Primary result
As reported in the abstract
60-day mortality (ITT)
- ExoFlo-15 vs Placebo: P = 0.1343
- Intention-to-treat
Secondary outcomes
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| 60-day mortality (post hoc subgroup) · 60 daysExoFlo-15 vs Placebo · n = 50 · post hoc subgroup analysis | 0.385 (0.159–0.931) | P = 0.0340 | |
| 60-day mortality, aged 18 to 65 years with moderate to severe ARDS (post hoc subgroup) · 60 daysExoFlo-15 vs Placebo · n = 24 · post hoc subgroup analysis | 0.423 (0.173–1.032) | P = 0.0588 | |
| 0.10.31310Relative risk (log scale) |
| Outcome | P value |
|---|---|
| Ventilation-free days, aged 18 to 65 yearsExoFlo-15 vs Placebo · improved; n = 50 | P = 0.0455 |
Safety
- No treatment-related adverse events reported
Original publication
Bone Marrow Mesenchymal Stem Cell-Derived Extracellular Vesicle Infusion for the Treatment of Respiratory Failure From COVID-19: A Randomized, Placebo-Controlled Dosing Clinical Trial. Chest. Published 23 June 2023. doi:10.
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