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

Recruiting Phase 3 Interventional Study
Acute Respiratory Distress Syndrome ARDS
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
970 (estimated)
Sponsor
Direct Biologics, LLC · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Men and women aged 18-75 years of age 2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion: 1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, incr…
Contacts

Bill Arana

1-800-791-1021

clinicalaffairs@directbiologics.com

CONTACT