CHEST Guidelines-Bone-Marrow-Mesenchymal-Stem-Cell-Derived-Extracel

Bone-Marrow-Mesenchymal-Stem-Cell-Derived-Extracel

Pdf Summary

The study investigates the safety and efficacy of ExoFlo, a bone marrow mesenchymal stem cell-derived extracellular vesicle product, for treating respiratory failure due to severe COVID-19. Conducted as a phase 2 randomized, placebo-controlled trial at five U.S. sites, the study involved 102 patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Participants received either a placebo or two different doses of ExoFlo (10 mL or 15 mL mixed with saline) on days 1 and 4. The primary goal was to evaluate the reduction in 60-day mortality.<br /><br />Results indicated that the 15 mL ExoFlo dose was safe, with no treatment-related adverse events reported across all groups. Preliminary efficacy was observed, showing reduced mortality rates in participants aged 18-65 with moderate to severe ARDS when treated with the higher ExoFlo dosage compared to placebo. In this subgroup, a significant decrease in 60-day mortality was noted, with improved ventilation-free days and shorter hospital stays, suggesting potential therapeutic benefits of ExoFlo for respiratory failures related to COVID-19.<br /><br />The overall study highlights ExoFlo's promising safety profile and potential for reducing morbidity and mortality in younger patients suffering from COVID-19-related respiratory distress. However, the study acknowledged its limited power to definitively establish efficacy due to small sample sizes, recommending further investigation in larger phase 3 trials to validate these findings.<br /><br />Supported by Direct Biologics, this study underlines the potential of extracellular vesicles in COVID-19 treatment, offering a glimpse at new avenues for managing ARDS beyond traditional cell-based therapies, with the U.S. FDA authorizing a phase 3 trial to explore ExoFlo's full potential further.

Keywords

ExoFlo

COVID-19

ARDS

extracellular vesicles

stem cell therapy

phase 2 trial

respiratory failure

60-day mortality

Direct Biologics

FDA phase 3 trial