Atrium Health Wake Forest Baptist | Anesthesiology Department
Status and phase
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About
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).
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men and women aged 18-75 years of age
Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
970 participants in 2 patient groups, including a placebo group
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Central trial contact
Bill Arana
Data sourced from clinicaltrials.gov
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