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Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
NCT05354141 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- BIOLOGICAL ExoFlo
- OTHER Intravenous normal saline
Study Locations (20)
California
- Direct Biologics Investigational Site — Davis
- Direct Biologics Investigational Site — Irvine
- Direct Biologics Investigational Site — Sacramento
Massachusetts
- Direct Biologics Investigational Site — Boston
- Direct Biologics Investigational Site — Burlington
- Direct Biologics Investigational Site — Springfield
New York
- Direct Biologics Investigational Site — Flushing
- Direct Biologics Investigational Site — Queens
- Direct Biologics Investigational Site — The Bronx
Arizona
- Direct Biologics Investigational Site — Phoenix
Arkansas
- Direct Biologics Investigational Site — Little Rock
District of Columbia
- Direct Biologics Investigational Site — Washington D.C.
Florida
- Direct Biologics Investigational Site — Jacksonville
Idaho
- Direct Biologics Investigational Site — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 970 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05354141
The ClinicalTrials.gov registry entry for NCT05354141 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 970 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Direct Biologics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions — of which ExoFlo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05354141 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05354141 about?
NCT05354141 is a clinical study titled "Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)". 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).
What is the current status of trial NCT05354141?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 970 participants. The study started on 2022-07-01. Estimated completion is 2027-12-31.
What conditions does trial NCT05354141 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, ARDS. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05354141?
The interventions under investigation include: ExoFlo (BIOLOGICAL), Intravenous normal saline (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05354141?
This trial is sponsored by Direct Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05354141 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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