Direct Biologics LLC, a biotechnology company in the late stages of development, has recently published groundbreaking findings from their Phase 2 clinical trial in the prestigious Journal CHEST. The trial focused on evaluating the effectiveness of ExoFlo™, a regenerative medicine platform that utilizes extracellular vesicles (EVs) derived from bone marrow-derived mesenchymal stem cells (BM-MSCs), in treating hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS). The results not only showcased promising safety data but also demonstrated significant efficacy, highlighting the potential of BM-MSC EVs in combating respiratory failure associated with COVID-19.
This Phase 2 trial was meticulously designed as a prospective, double-blind, randomized, and placebo-controlled study conducted across five reputable medical facilities throughout the United States. A total of 102 patients diagnosed with moderate-to-severe ARDS were enrolled and randomly assigned to either receive a placebo or varying doses of ExoFlo. Throughout the duration of the trial, no adverse events related to the treatment were reported. The overall mortality rate among all participants was recorded at 61.0%.