Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial
Direct Biologics, LLC
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).
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).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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, increasing oxygen flows, or increased work of breathing, and 2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and 3. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and 4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous…
Interventions
- BiologicalExoFlo
Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
- OtherIntravenous normal saline
Placebo
Locations (32)
- Direct Biologics Investigational SitePhoenix, Arizona
- Direct Biologics Investigational SiteLittle Rock, Arkansas
- Direct Biologics Investigational SiteDavis, California
- Direct Biologics Investigational SiteIrvine, California
- Direct Biologics Investigational SiteSacramento, California
- Direct Biologics Investigational SiteWashington D.C., District of Columbia