Boca Raton Regional Hospital Researchers Launch COVID-19 Clinical Trial to Investigate New Treatment for Critical Patients
BOCA RATON, FL – October 8, 2020 – Physicians at the Marcus Neuroscience Institute at Boca Raton Regional Hospital have launched and are part of a multi-institutional randomized study on the use of umbilical cord stem cells to treat patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection. The treatment involves an infusion of mesenchymal stem cells (MSC), known for their ability to reduce inflammation and regenerate damaged lung tissue.
“We are hopeful that treatment with mesenchymal stem cells will reduce the effects of ARDS, which can be life-threatening and result in the deterioration of some patients with severe cases of COVID-19,” said principal investigator Frank Vrionis, M.D., Ph.D., Marcus Neuroscience Institute director and chief of neurosurgery at Boca Raton Regional Hospital. “It’s a unique and promising therapeutic option for an infectious disease for which we have no cure or vaccine at the moment.” Investigators from Duke University, Wake Forest and New York Medical College are among those participating in the study.
The Phase 1/2a multi-center randomized study, called “Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS), will enroll 30 patients with COVID-19 and ARDS who meet specific criteria. Patients will receive the cells via IV, once a day for three consecutive days.
MSC cells derived from the umbilical cord have been used with success to treat other pulmonary conditions and illnesses. They have also been used safely on a small number of COVID-19 patients through the FDA’s compassionate use authorization.
“Our study will help provide the scientific data to evaluate the safety and effectiveness of the treatment,” Dr. Vrionis said. “We are excited to be part of a promising potential coronavirus therapy.”
The trial’s co-principal investigator is Joanne Kurtzberg, M.D., director of the Carolinas Cord Blood Bank and co-director of the Stem Cell Transplant Laboratory at Duke University School of
Medicine/Duke Health. Ralph Palumbo, M.D., medical director of Critical Care and medical director of Respiratory Care Services at Boca Raton Regional Hospital, is a co-director of the study, as well as Khalid Hanafy, M.D., Ph.D., director of Neuro-Critical care at Marcus Neuroscience Institute.
About the Marcus Neuroscience Institute
The Marcus Neuroscience Institute at Boca Raton Regional Hospital is an innovative nexus for neurologic and neurosurgical care. The 57,000-square-foot facility houses a 20-bed Neuro Intensive Care and Step-Down Unit, four dedicated operating rooms — including one equipped with intraoperative MRI and two with intraoperative CT capability — and a biplane angiography suite, a crucial component in the diagnosis and care of neurological conditions. The Institute has a staff of five neurosurgeons and nine neurologists who represent some of the most respected clinicians in their fields and is affiliated with Florida Atlantic University’s Charles E. Schmidt College of Medicine.
About Boca Raton Regional Hospital
Boca Raton Regional Hospital is part of Baptist Health South Florida, the largest healthcare organization in the region, with 11 hospitals, nearly 23,000 employees, more than 4,000 physicians and more than 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and Baptist Health Care On Demand, a virtual health platform. A not-for-profit organization supported by philanthropy and committed to our faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World’s Most Ethical Companies. For more information, visit BaptistHealth.net/Newsroom and connect with us on Facebook, Instagram, Twitter and LinkedIn.