Baldwin Park, California, Oct. 3, 2024 – StemCyte announced today that its Hematopoietic Progenitor Cell Cord Blood therapy (HPC Cord Blood) has officially obtained the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of Long COVID-19 syndrome. StemCyte is one of the few cell therapy companies in the United States to receive the FDA-granted RMAT designation.

 

Long COVID-19 syndrome is a severe and persistent consequence of COVID-19, for which no effective treatment currently exists. StemCyte’s HPC Cord Blood is the world’s first cord blood cell therapy to receive FDA approval for a Phase II clinical trial specifically for Long COVID-19. The RMAT designation, which was largely based on positive outcomes from the Phase II trial, enables StemCyte to collaborate closely with the FDA to expedite development, gain priority review, and leverage accelerated approval opportunities for future indications.

 

The Phase II clinical trial of HPC Cord Blood was successfully completed within eight months in the United States, achieving full patient enrollment. StemCyte expects to unblind the results soon. The RMAT designation not only brings hope to patients suffering from Long COVID-19 but also expands the potential applications for HPC Cord Blood. Currently, StemCyte is in the planning stages for a Phase III clinical trial under FDA guidance. Significant progress has also been made on the Biologics License Application (BLA) for the HPC Cord Blood product (RegeneCyte), with StemCyte expecting to receive FDA approval by the end of the year to utilize 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 that show breakthrough therapeutic potential and address significant unmet medical needs. According to the FDA, as of June 2024, there have been 279 RMAT applications submitted worldwide, with successful approvals including Kymriah®, Abecma®, and Breyanzi® CAR-T treatments. StemCyte is honored to be the only cell therapy company to achieve this milestone for its HPC Cord Blood.