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Treatment for Acute Respiratory Distress Syndrome using Extracellular Vesicles

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial

Phase 3 Interventional Direct Biologics, LLC · NCT05354141

This study is testing a new treatment called ExoFlo to see if it can help hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome breathe better and improve their overall health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment970 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorDirect Biologics, LLC Industry-sponsored
Locations32 sites (Phoenix, Arizona and 31 other locations)
Trial IDNCT05354141 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the safety and efficacy of ExoFlo, an intravenous treatment derived from bone marrow mesenchymal stem cell extracellular vesicles, in hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The study is multicenter, randomized, and double-blinded, comparing ExoFlo to a placebo. Participants will be monitored for improvements in respiratory function and overall health outcomes. The trial aims to provide a new therapeutic option for patients suffering from this severe condition.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18-75 with moderate-to-severe ARDS as defined by specific clinical criteria.

Not a fit: Patients with ARDS not meeting the inclusion criteria or those with respiratory failure due to cardiac issues or fluid overload may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery rates and respiratory function in patients with ARDS.

How similar studies have performed: Other studies have shown promise with similar approaches using extracellular vesicles, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Respiratory Distress SyndromeARDSExoFloExtracellular VesiclesExosome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.