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Can stem cell vesicles save lives in severe ARDS?

NCT ID NCT05354141

Recruiting now Disease control Sponsor: Direct Biologics, LLC Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a single intravenous dose of ExoFlo, made from bone marrow stem cell vesicles, can lower the death rate in hospitalized adults with moderate-to-severe ARDS. About 970 participants will receive either ExoFlo or a placebo. The main goal is to see if ExoFlo reduces deaths within 60 days and helps patients get off ventilators and oxygen faster.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
ExoFlo (bone marrow stem cell derived extracellular vesicles)
What this could lead to
If it works, this could provide a new treatment to reduce deaths and speed recovery in patients with severe lung inflammation (ARDS).
What could go wrong
This is still an experimental treatment. Even in phase 3, it may not prove better than placebo, and side effects from the intravenous vesicles are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE RESPIRATORY DISTRESS SYNDROME ARDS

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Direct Biologics Investigational Site

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Davis, California, 95817, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Irvine, California, 92627, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Sacramento, California, 95817, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Boise, Idaho, 83712, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Silver Spring, Maryland, 20910, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Springfield, Massachusetts, 01199, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Jackson, Mississippi, 39202, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Flushing, New York, 11368, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Queens, New York, 11040, United States

  • Direct Biologics Investigational Site

    RECRUITING

    The Bronx, New York, 10467, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Knoxville, Tennessee, 37996, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Nashville, Tennessee, 37235, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Direct Biologics Investigational Site

    NOT_YET_RECRUITING

    Murray, Utah, 84107, United States

  • Direct Biologics Investigational Site

    RECRUITING

    Salt Lake City, Utah, 84101, United States

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