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

NCT05354141 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2026-02-23

No results posted yet for this 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

  • Acute Respiratory Distress Syndrome
  • ARDS

Interventions

BIOLOGICAL

ExoFlo

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

OTHER

Intravenous normal saline

Placebo

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2027-11-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05354141 on ClinicalTrials.gov