StemCyte's HPC Cord Blood Gets RMAT Status for Long COVID-19 Treatment

BALDWIN PARK, Calif., Oct. 3, 2024 - StemCyte announced today that its Hematopoietic Progenitor Cell Cord Blood therapy (HPC Cord Blood) has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for treating Long COVID-19 syndrome. This distinction makes StemCyte one of the few cell therapy companies in the U.S. to obtain RMAT status.

Long COVID-19 syndrome represents a serious and long-term aftermath of COVID-19, lacking an effective treatment so far. StemCyte’s HPC Cord Blood is distinguished as the first cord blood cell therapy to get FDA approval for a Phase II clinical trial aimed specifically at Long COVID-19. The RMAT designation, awarded primarily due to the promising Phase II trial results, allows StemCyte to work closely with the FDA to speed up development, secure priority review, and take advantage of accelerated approval for future treatments.

The Phase II clinical trial of HPC Cord Blood was effectively completed within eight months in the U.S., with all patient slots filled. StemCyte is set to unblind the results shortly. The RMAT designation brings optimism to those suffering from Long COVID-19 and broadens the potential applications of HPC Cord Blood. StemCyte is currently in the initial stages of planning a Phase III clinical trial under FDA supervision. Additionally, there has been considerable progress on the Biologics License Application (BLA) for their HPC Cord Blood product, RegeneCyte. StemCyte aims to get FDA approval by year-end to use umbilical cord blood-derived hematopoietic stem cells as a treatment for cancers, blood disorders, and immune deficiencies.

The FDA's RMAT designation is reserved for products demonstrating significant therapeutic potential and addressing major unmet medical needs. As of June 2024, 279 RMAT applications have been submitted globally, with notable approvals for treatments like Kymriah®, Abecma®, and Breyanzi® CAR-T therapies. StemCyte is proud to be the sole cell therapy company to reach this milestone with HPC Cord Blood.

StemCyte is a leading entity in regenerative medicine, focusing on pioneering therapies that use cord blood. With a commitment to introducing advanced cellular therapies, StemCyte strives to enhance health outcomes for patients around the world.