FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)

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Dr. Joanne Kurtzberg at Duke University will lead a clinical trial using human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with Multisystem Inflammatory Syndrome in Children (MIS-C). The study will determine if these cells can suppress inflammation and handle the long term impact of the syndrome. the Robertson GMP Cell Manufacturing Laboratory at Duke produces the cells. The FDA approved the IND application for this study.

The American Academy of Pediatrics has indicated that the amount of children with the virus has tripled in the last 2 months. It is now more than half a million children in the US with the virus. Some of these children have become seriously ill.

As of September 3rd, 9.8% of diagnosed cases in the U.S. are children and some states like Alaska, Minnesota, Tennessee, South Carolina, New Mexico and Wyoming, children make up more than 15 percent of total confirmed cases. The Centers for Disease Control and Prevention stated that at least 792 children in 42 states have been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C) and 16 have died.

“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.”

This ambitious study is a joint effort from the following sponsors: The Cure Foundation, The Marcus Foundation, Sanford Health, Duke Health, and the Alliance for Cell Therapy Now.

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