New Stem Cell Therapy for COVID-19 Finds Success in Clinical Trial at Baptist Health

Three COVID-19patients at Baptist Hospital of Miami – all critically ill with acute respiratory distress syndrome (ARDS)– are the first in the U.S. to successfully be treated with umbilical cordmesenchymal stem cells.

In a clinicaltrial being conducted under an emergency approval from the Food and DrugAdministration (FDA), Baptist Health physicians Guenther Koehne, M.D., Ph.D., and Javier Pérez-Fernández, M.D., safely administered the new treatment topatients through intravenous infusions of experimental umbilical cord lining-derivedstem cells (ULSC).

(Watch Now: Ruthie Ramirez, 32, one of the first COVID-19 patients in the U.S. successfully treated with mesenchymal stem cell therapy, is greeted by her children and coworkers after spending three weeks in Baptist Hospital.)

The stem cellswere produced by RESTEM, a leading-edge biotechnology company dedicated to the discoveryand development of cell-based therapeutics. RESTEM’s cells are grown fromumbilical cord tissue by a proprietary process and reduce inflammation, therebyallowing tissue regeneration and healing to occur.

The patients whoreceived the treatment were on ventilation support and showed reduction of theiroxygen requirement from 100 percent to less than 50 percent within days of theinfusion. This was accompanied by a significant reduction in levels of variouskey circulating inflammatory markers, meaning the harmful inflammationcrippling the lungs of all three patients was not only arrested but reversed.

“The remarkableability for these cells to mitigate inflammatory processes holds great promisefor COVID-19 patients as well as for people with many other illnesses,” said Dr.Koehne, deputy director and chief of blood & marrowtransplant at Miami Cancer Institute, part of Baptist Health, andPrincipal Investigator for the study, which is currently undergoing review atthe FDA. “These patients have improved their lung status much more quickly thanpatients treated with other experimental therapies.”

All three patients were critically ill and suffered from significant co-morbidities, or underlying conditions, according to Dr. Koehne, who is also professor and chairperson of the Department of Translational Medicine at the Herbert Wertheim College of Medicine (HWCOM) at Florida International University (FIU). Specialists at HWCOM spearheaded this collaborative effort between academia, Baptist Health and RESTEM.

Dr. Pérez-Fernández,pulmonologist and director of critical care at Baptist Hospital, is extremely impressedwith the outcomes they’ve seen so far. “Our preliminary results show thattherapy with these cells could be a game-changer in COVID-19.”

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