An international team of scientists led by Camillo Ricordi, M.D., director of the Diabetes Research Institute and Cell Transplant Center at the University of Miami Miller School of Medicine, has been granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells to block the life-threatening lung inflammation that accompanies severe cases of COVID-19.
“There is no time to waste,” said Dr. Ricordi, the principal investigator, who is the Stacy Joy Goodman Professor of Surgery. “Patients who die from COVID-19 have a median time of just 10 days between first symptoms and death. In severe cases oxygen levels in the bloodstream drop, and the inability to breathe pushes patients toward their end very quickly; any intervention that might prevent that trajectory would be highly desirable.”
The trial will be based at the University of Miami Health System and Jackson Health System. It is the result of a collaborative academic initiative sponsored by The Cure Alliance, a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases. In response to the COVID-19 pandemic, The Cure Alliance has pivoted all resources to fighting the virus. The clinical protocol has been shared with other academic institutions throughout the world who want to test similar treatment strategies in the fastest and most efficient way possible.
“We are very grateful to the FDA’s Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, for performing four rounds of reviews in a record time — one week,” said Dr. Ricordi.
The FDA had previously authorized the testing of umbilical cord-derived mesenchymal stem cell products in patients with type 1 diabetes and Alzheimer’s disease at the University of Miami as part of other clinical trials. For the COVID-19 trial, Dr. Ricordi enlisted additional experts from around the world with extensive experience in infectious diseases, pulmonary medicine and critical care, while others provided expertise in cell-based product development and their use in clinical trials. The cell therapy is administered intravenously.