FDA Approval for EXIT-COVID-19
The FDA approved a Phase II trial to use the treatment ExoFlo for patients with COVID-19. In fact, previous clinical trials suggest that ExoFlo can enhance tissue repair and modulate the immune system.
ExoFlo is an investigational treatment that has not been approved or licensed by the FDA. It is an allograft extracellular vesicle treatment derived from human bone marrow mesenchymal stem or stromal cells (MSC’s). ExoFlo activates signaling proteins that have been demonstrated to regulate inflammation and may trigger bioactivity and manage cellular communication.
Mark Adams, Co-Founder and Chief Executive Officer of Direct Biologics, stated, “We are pleased the FDA has approved Direct Biologics to proceed with our study in the treatment of severe COVID-19 infections. In addition to its promise in treating COVID-19, the ongoing clinical and scientific research suggests that our proprietary advanced biotechnology platform has the potential to be part of a new class of medicine that may generate positive medical outcomes for patients.”
The study will enroll 60 patients with COVID-19 at 3 different research sites in the US. Indeed, it is perhaps the only trial as of this writing that applies regenerative medicine to patients with COVID-19. Until there is a vaccine, the scientific data suggests this therapeutic has great promise in treating patients.