๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-20

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) (NCT05354141)

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Direct Biologics, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Direct Biologics Investigational Site โ€” Phoenix, Arizona

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (32 Sites)

Showing the first 25 of 32 sites.

  • Direct Biologics Investigational Site โ€” Phoenix, Arizona
  • Direct Biologics Investigational Site โ€” Little Rock, Arkansas
  • Direct Biologics Investigational Site โ€” Davis, California
  • Direct Biologics Investigational Site โ€” Irvine, California
  • Direct Biologics Investigational Site โ€” Sacramento, California
  • Direct Biologics Investigational Site โ€” Washington D.C., District of Columbia
  • Direct Biologics Investigational Site โ€” Jacksonville, Florida
  • Direct Biologics Investigational Site โ€” Boise, Idaho
  • Direct Biologics Investigational Site โ€” Iowa City, Iowa
  • Direct Biologics Investigational Site โ€” Silver Spring, Maryland
  • Direct Biologics Investigational Site โ€” Boston, Massachusetts
  • Direct Biologics Investigational Site โ€” Burlington, Massachusetts
  • Direct Biologics Investigational Site โ€” Springfield, Massachusetts
  • Direct Biologics Investigational Site โ€” Detroit, Michigan
  • Direct Biologics Investigational Site โ€” Rochester, Minnesota
  • Direct Biologics Investigational Site โ€” Jackson, Mississippi
  • Direct Biologics Investigational Site โ€” Flushing, New York
  • Direct Biologics Investigational Site โ€” Queens, New York
  • Direct Biologics Investigational Site โ€” The Bronx, New York
  • Direct Biologics Investigational Site โ€” Durham, North Carolina
  • Direct Biologics Investigational Site โ€” Winston-Salem, North Carolina
  • Direct Biologics Investigational Site โ€” Cincinnati, Ohio
  • Direct Biologics Investigational Site โ€” Cleveland, Ohio
  • Direct Biologics Investigational Site โ€” Portland, Oregon
  • Direct Biologics Investigational Site โ€” Charleston, South Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 791-1021

Email: clinicalaffairs@directbiologics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—