Phase III Study of Intravenous Bone Marrow Stem Cell Extracellular Vesicles for Treating Moderate-to-Severe ARDS in Hospitalized Adults

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.

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