Clinical Trial

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

Recruiting Phase 3
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Summary
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Protocol Amendment History 38 amendments
This ClinicalTrials.gov record has been amended 38 times since 2022-04-27; most recent amendment 2026-02-20.
Status change: Not Yet Recruiting → Recruiting 2022-07-11
Trial Details
NCT Number NCT05354141
Lead Sponsor Direct Biologics, LLC
Conditions Acute Respiratory Distress Syndrome, ARDS
Enrollment 970 participants
Start Date 2022-07-01
Primary Completion 2027-11-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-23