Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Condition(s) studied
Investigational drug(s) / intervention(s)
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
Intravenous normal saline: Placebo
Study 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).
Eligibility
Primary outcome measure(s)
- Evaluation of 60-day All-cause Mortality — 60 days
To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Direct Biologics Investigational Site | Phoenix | Arizona | Recruiting |
| Direct Biologics Investigational Site | Little Rock | Arkansas | Recruiting |
| Direct Biologics Investigational Site | Davis | California | Recruiting |
| Direct Biologics Investigational Site | Irvine | California | Recruiting |
| Direct Biologics Investigational Site | Sacramento | California | Recruiting |
| Direct Biologics Investigational Site | Washington D.C. | District of Columbia | Recruiting |
| Direct Biologics Investigational Site | Jacksonville | Florida | Recruiting |
| Direct Biologics Investigational Site | Boise | Idaho | Recruiting |
| Direct Biologics Investigational Site | Iowa City | Iowa | Recruiting |
| Direct Biologics Investigational Site | Silver Spring | Maryland | Recruiting |
| Direct Biologics Investigational Site | Boston | Massachusetts | Recruiting |
| Direct Biologics Investigational Site | Burlington | Massachusetts | Recruiting |
| Direct Biologics Investigational Site | Springfield | Massachusetts | Recruiting |
| Direct Biologics Investigational Site | Detroit | Michigan | Recruiting |
| Direct Biologics Investigational Site | Rochester | Minnesota | Recruiting |
| Direct Biologics Investigational Site | Jackson | Mississippi | Recruiting |
| Direct Biologics Investigational Site | Flushing | New York | Recruiting |
| Direct Biologics Investigational Site | Queens | New York | Recruiting |
| Direct Biologics Investigational Site | The Bronx | New York | Recruiting |
| Direct Biologics Investigational Site | Durham | North Carolina | Recruiting |
| Direct Biologics Investigational Site | Winston-Salem | North Carolina | Recruiting |
| Direct Biologics Investigational Site | Cincinnati | Ohio | Recruiting |
| Direct Biologics Investigational Site | Cleveland | Ohio | Recruiting |
| Direct Biologics Investigational Site | Portland | Oregon | Recruiting |
| Direct Biologics Investigational Site | Charleston | South Carolina | Recruiting |
| Direct Biologics Investigational Site | Knoxville | Tennessee | Recruiting |
| Direct Biologics Investigational Site | Nashville | Tennessee | Recruiting |
| Direct Biologics Investigational Site | Dallas | Texas | Recruiting |
| Direct Biologics Investigational Site | Fort Worth | Texas | Recruiting |
| Direct Biologics Investigational Site | Houston | Texas | Recruiting |
| Direct Biologics Investigational Site | Murray | Utah | Not Yet Recruiting |
| Direct Biologics Investigational Site | Salt Lake City | Utah | Recruiting |
More Direct Biologics, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05354141 on ClinicalTrials.gov ↗ ← All trials in the USA