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Clinical Trial 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).


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05354141
Study type Interventional
Source Direct Biologics, LLC
Contact Bill Arana
Phone 1-800-791-1021
Email clinicalaffairs@directbiologics.com
Status Recruiting
Phase Phase 3
Start date July 1, 2022
Completion date August 31, 2025

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