April 16 (UPI) -- Researchers at the University of Miami Miller School of Medicine received approval Thursday from the U.S. Food and Drug Administration to start a small clinical trial using stem cells against COVID-19.
The trial will evaluate use of umbilical cord-derived mesenchymal stem cells to address life-threatening lung inflammation suffered by people with the severe form of the disease caused by the new coronavirus.
"There is no time to waste," Dr. Camillo Ricordi, director of the Diabetes Research Institute and Cell Transplant Center at the school and the principal investigator on the trial, said in a press release. "Patients who die from COVID-19 have a median time of just 10 days between first symptoms and death."
To date, nearly 650,000 Americans are confirmed to have the coronavirus, and more than 30,000 have died. Most people who die from COVID-19, the disease caused by the coronavirus SARS-CoV-2, develop a severe lower-respiratory tract infection, like pneumonia.
"In severe cases oxygen levels in the bloodstream drop, and the inability to breathe pushes patients toward their end very quickly," Ricordi said. "Any intervention that might prevent that trajectory would be highly desirable."
Ricordi will begin the 24-patient clinical trial to test safety and efficacy of stem cells, administered intravenously, to block the life-threatening lung inflammation as soon as possible. The trial will be based at the University of Miami Health System and Jackson Health System, and is being conducted under the auspices of The Cure Alliance, a non-profit group of scientists dedicated to accelerating the development of cures for all diseases.
The Cure Alliance has pivoted all of its resources toward fighting COVID-19. The group has shared the clinical protocol for the stem cell trial with other academic institutions throughout the world so that they can test similar treatment strategies.
Previously, the FDA has authorized the use 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, 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.
"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 Ricordi.