FDA Approves Study to Investigate Cell Therapy to Treat COVID-19 Related MIS-C

The Cura Foundation in collaboration with The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now, is supporting a clinical trial of human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with Multisystem Inflammatory Syndrome in Children (MIS-C). The trial is being led by Dr. Joanne Kurtzberg at Duke University to determine if infusions of hCT-MSCs are safe and can suppress the hyper-inflammatory response and positively impact the symptom course and duration, as well as the long-term effects of this life-threatening syndrome. The hCT-MSCs are manufactured in the Robertson GMP Cell Manufacturing Laboratory at Duke. The U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) Application, and Dr. Kurtzberg will proceed with a multi-site pilot study later this month.

According to the American Academy of Pediatrics (AAP), the cumulative number of coronavirus cases diagnosed in children has more than tripled between July 2 and September 3 from 165,845 to 513,415. As of September 3rd, children represent at least 9.8% of diagnosed cases in the U.S. and in states such as Alaska, Minnesota, Tennessee, South Carolina, New Mexico and Wyoming, children account for more than 15 percent of total cases. Some of these children have developed very serious disease. The Centers for Disease Control and Prevention reported that as of September 3rd at least 792 children in 42 states have been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C) and 16 have died.

The Principal Investigator of the study, Joanne Kurtzberg, MD, is the Jerome Harris Distinguished Professor of Pediatrics; Professor of Pathology; Director, Marcus Center for Cellular Cures; Director, Pediatric Blood and Marrow Transplant Program; Director, Carolinas Cord Blood Bank; Co-Director, Stem Cell Transplant Laboratory at Duke University School of Medicine/Duke Health and a leader in transplantation, cell therapy, and regenerative medicine in children. Clinical sites include Duke University (Durham, NC), Children's Healthcare of Atlanta (Atlanta, GA), New York Medical College (Valhalla, NY), and others as cases occur.

"We hope this is just the beginning of our ability to support the development of cell therapies to treat COVID-19 Related Multisystem Inflammatory Syndrome in Children," said Dr. Robin Smith, president of the Cura Foundation. "As students across the country return to in-class instruction, it is more important now than ever to ensure we are equipped with potential treatment options to care for children who develop this serious disease."