What is ExoFlo studying for Acute Respiratory Distress Syndrome (ARDS)?

ExoFlo is being studied to assess its safety and effects compared to a placebo in adults hospitalized with moderate-to-severe ARDS. The trial aims to understand if this biological treatment can improve outcomes for patients with this serious lung condition. The study is sponsored by Direct Biologics, LLC and uses a rigorous design to evaluate the treatment.

Who may be eligible for this Acute Respiratory Distress Syndrome (ARDS) clinical trial?

Adults aged 18 to 75 years with moderate to severe ARDS diagnosed within the last 7 days may be eligible. Participants must be on certain types of breathing support and not have serious liver disease, active cancer treatment recently, or be connected to ECMO. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Acute Respiratory Distress Syndrome (ARDS) clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect the necessary treatments and assessments to be covered by the study.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

ID05354141

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

Led by Direct Biologics, LLC · Updated on 2026-02-23

970

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intravenous bone marrow mesenchymal stem cell derived extracellular vesicles, called ExoFlo, compared to a placebo in hospitalized adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). This Phase III, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for ARDS using this biological therapy. Participants will be randomly assigned to receive either an intravenous infusion of ExoFlo mixed with normal saline or a placebo infusion of normal saline alone. The study uses a triple-blinded design to ensure unbiased results. The treatments are given during the hospital stay, and the trial monitors outcomes over 60 days following administration. During the study, participants will undergo evaluations including monitoring for survival over 60 days, time to death, ventilator-free days, oxygen-free days, ICU-free days, and any serious adverse events related to treatment. These assessments will help measure the overall impact and safety of the treatment. The total participation time covers 61 days, with close observation for treatment effects and safety throughout this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Men and women aged 18-75 years
Moderate to severe ARDS diagnosed within 24 hours before the first infusion, defined by Berlin Criteria
Onset within 7 days of known clinical insult or worsening breathing support
Bilateral lung opacities not explained by other causes
PaO2/FiO2 ratio of 200 mm Hg or less
Receiving invasive or noninvasive ventilation with minimum PEEP 5 cm H2O or CPAP 5 cm H2O, or High Flow Nasal Oxygen at 30 L/min or more
Respiratory failure not caused by heart failure or fluid overload

You will not qualify if you...

No signed informed consent form
Unwilling to comply with study procedures or unavailable for study duration
Pregnant, children, or individuals unable to provide consent
Active cancer requiring treatment within last 2 years (except non-melanoma skin cancers)
Major physical trauma in last 2 days that may be undiagnosed
Mechanical ventilation for more than 3 days or 72 hours from ARDS diagnosis
ALT or AST greater than 8 times upper limit of normal
History of liver cirrhosis
Do Not Resuscitate (DNR) order
Expected survival less than 24 hours
Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH less than 7.2)
Connected to Extracorporeal Membrane Oxygenation (ECMO) at screening
Unwilling to use two methods of highly effective birth control or abstinence during study period if of reproductive potential
Use of investigational COVID-19 or other agents within 30 days prior to first dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single infusion with monitoring through Day 61

Participants receive intravenous administration of either bone marrow mesenchymal stem cell derived extracellular vesicles or placebo.

1 infusion visit and multiple follow-up visits up to 61 days