Ireland
--:--IST
Recruiting Phase 3

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

NCT05354141 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2022-07-01
Last updated
2026-02-23

Condition(s) studied

Acute Respiratory Distress SyndromeARDS

Investigational drug(s) / intervention(s)

ExoFloIntravenous normal saline

ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Intravenous normal saline: Placebo

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men and women aged 18-75 years of age 2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion: 1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and 2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and 3. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and 4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L/min, and 5. Respiratory failure not fully explained by cardiac failure or fluid overload. Exclusion Criteria: 1. Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy). 2. Stated unwillingness to comply with all study procedures and availability for the duration of the study 3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent. 4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers. 5. Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening. 6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS. 7. ALT or AST \> 8 x Upper Limit of Normal (ULN). 8. Documented history of cirrhosis. 9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation. 10. Moribund-expected survival \< 24 hours. 11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \< 7.2) 12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening. 13. If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination 14. Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.

Primary outcome measure(s)

  • Evaluation of 60-day All-cause Mortality — 60 days
    To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.

Trial sites (32)

FacilityCityRegionStatus
Direct Biologics Investigational Site Phoenix Arizona Recruiting
Direct Biologics Investigational Site Little Rock Arkansas Recruiting
Direct Biologics Investigational Site Davis California Recruiting
Direct Biologics Investigational Site Irvine California Recruiting
Direct Biologics Investigational Site Sacramento California Recruiting
Direct Biologics Investigational Site Washington D.C. District of Columbia Recruiting
Direct Biologics Investigational Site Jacksonville Florida Recruiting
Direct Biologics Investigational Site Boise Idaho Recruiting
Direct Biologics Investigational Site Iowa City Iowa Recruiting
Direct Biologics Investigational Site Silver Spring Maryland Recruiting
Direct Biologics Investigational Site Boston Massachusetts Recruiting
Direct Biologics Investigational Site Burlington Massachusetts Recruiting
Direct Biologics Investigational Site Springfield Massachusetts Recruiting
Direct Biologics Investigational Site Detroit Michigan Recruiting
Direct Biologics Investigational Site Rochester Minnesota Recruiting
Direct Biologics Investigational Site Jackson Mississippi Recruiting
Direct Biologics Investigational Site Flushing New York Recruiting
Direct Biologics Investigational Site Queens New York Recruiting
Direct Biologics Investigational Site The Bronx New York Recruiting
Direct Biologics Investigational Site Durham North Carolina Recruiting
Direct Biologics Investigational Site Winston-Salem North Carolina Recruiting
Direct Biologics Investigational Site Cincinnati Ohio Recruiting
Direct Biologics Investigational Site Cleveland Ohio Recruiting
Direct Biologics Investigational Site Portland Oregon Recruiting
Direct Biologics Investigational Site Charleston South Carolina Recruiting
Direct Biologics Investigational Site Knoxville Tennessee Recruiting
Direct Biologics Investigational Site Nashville Tennessee Recruiting
Direct Biologics Investigational Site Dallas Texas Recruiting
Direct Biologics Investigational Site Fort Worth Texas Recruiting
Direct Biologics Investigational Site Houston Texas Recruiting
Direct Biologics Investigational Site Murray Utah Not Yet Recruiting
Direct Biologics Investigational Site Salt Lake City Utah Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05354141 on ClinicalTrials.gov ↗ ← All trials in the USA