FDA approves stem cell research for COVID-19
Restem stated that the FDA approved their Phase I/II study testing mesenchymal stem cells on patients with COVID-19. This clinical trial is the first of this type in the USA. Researchers enroll patients from Baptist Health South Florida and Sanford Health this week.
“We are excited to launch this study and demonstrate the potential of our patented umbilical cord lining stem cell (ULSC) technology,” said Dr. Rafael Gonzalez, senior vice president of research and development for RESTEM. “Based on the properties of our cells and targeted treatments, our breakthrough technology has shown promise to help those suffering from COVID-19 complications.”
Besides, clinicians observed positive outcomes for patients hospitalized at Miami Cancer Institute. Guenther Koehne, M.D., Ph.D., deputy director of the Miami Cancer Institute directed the study as the prinicipal investigator.
Emergency Approval
The FDA gave Emergency Approval for the medical teams to use mesenchymal stem cells from umbilical cords. These donations happen after a live, healthy birth where both mother and child are well and the umbilical cord is not discarded.
Indeed, the study will be a randomized, placebo-controlled blinded trial to test the effectiveness of the therapy on patients with extreme conditions due to COVID-19.
SUCCESS Trial
The team gave an acronym for this trial: Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS). Baptist Health South Florida in Miami, Florida collaborates with Sanford Health in Sioux Falls, South Dakota, with COVID-19 patients who have developed ARDS.
“Based on the initially observed improvement of the patients treated, we are now looking forward to enrolling these severely ill patients onto the clinical trial. We are grateful to the FDA to have this clinical trial reviewed and approved in a timely manner during this difficult time,” said Dr. Guenther Koehne. He is the chairman of the Department of Translational Medicine at Herbert Wertheim College of Medicine at Florida International University and the principal investigator of this clinical trial.
“We’re excited to bring a potentially breakthrough treatment to our patients with the most severe cases of COVID-19,” said David A. Pearce, Ph.D., president of innovation and research at Sanford Health. “It’s a privilege to partner with RESTEM on this groundbreaking approach, which has already shown remarkable promise.”