Boca Raton Regional Hospital Researchers Launch COVID-19 Clinical Trial to Investigate New Treatment for Critical Patients
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.