NCT05354141

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

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 970 (estimated)
• Sponsor: Direct Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase III, multicenter, randomized, double-blinded, placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

Conditions

• Acute Respiratory Distress Syndrome
• ARDS

Interventions

Type	Name	Description
BIOLOGICAL	ExoFlo	Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
OTHER	Intravenous normal saline	Placebo

Timeline

• Start date: 2022-07-01
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2022-04-29
• Last updated: 2026-02-23

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study