Carl I Schulman, Nicholas Namias, Louis Pizano, Booker T King, Shelley Hartman, Gloria Mathews, Willistine Lenon, Heidi Kempinski, Luis Rodriguez-Menocal, Wellington Guzman, Arron Sandoval, Evangelos V Badiavas
Burn injuries are challenging to treat due to wound progression and long-term scarring. Mesenchymal stem cell (MSC)-derived extracellular vesicles (EVs) have regenerative and immunomodulatory properties that may mitigate these complications. In this Phase 1/2a, first-in-human, open-label study, a 47-year-old man with deep second-degree burns received a single topical dose of allogeneic bone marrow MSC-derived EVs within 48 hours of injury. The treated wound achieved >99% closure within one week, with durable healing for over one year. Scar outcomes improved over 52 weeks, with POSAS scores indicating early resolution of pain and pruritus and minimal residual scarring. No adverse events occurred. Laser Doppler imaging showed improved perfusion within one week, suggesting prevention of burn wound conversion. These findings support the potential of MSC-derived EVs to accelerate burn healing and reduce scar-related morbidity.