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Could stem cell particles save lives in severe lung failure?

NCT ID NCT05354141

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

First seen Feb 27, 2026 · Last updated May 17, 2026 · Updated 13 times

Summary

This Phase 3 trial tests whether a treatment called ExoFlo, made from stem cell particles, can help hospitalized adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS), a serious lung condition. About 970 participants will receive either ExoFlo or a placebo through an IV. The main goal is to see if ExoFlo reduces the number of deaths within 60 days.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• 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

Conditions

Explore the condition pages connected to this study.

ACUTE RESPIRATORY DISTRESS SYNDROME ARDS