U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE™ Cord Blood Cell Therapy Product

BALDWIN PARK, Calif., Nov. 22, 2024 /PRNewswire/ -- StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE™, a vital cord blood stem cell therapy for transplantation in patients with blood and immune system disorders. With this approval, StemCyte became the 15th company to receive BLA approval in 2024 and the first commercial U.S. based biotech company to secure a biologics license for cord blood stem cell therapy.

REGENECYTE™ is an allogeneic hematopoietic stem cell therapy derived from human umbilical cord blood. It is approved for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

In addition to REGENECYTE™, StemCyte is exploring the potential of its other HPC, Cord Blood products for emerging therapeutic applications, including chronic fatigue syndrome, aging-related diseases, and other conditions associated with suboptimal health. The company is also advancing Phase II clinical trials investigating the use of HPC, Cord Blood in treating long COVID syndrome and acute stroke, reinforcing its commitment to expanding the frontiers of regenerative medicine.

"With one of the largest inventories of cord blood stem cells worldwide, StemCyte is uniquely positioned to supply, manufacture, and develop advanced cell therapy products," said Dr. Tong Young Lee, CEO of StemCyte. "Looking ahead, we are committed to driving the development of innovative therapies, achieving sustainable growth through diversified business strategies, and solidifying our position as a global leader in the field of cell therapy."

StemCyte International Ltd. is expected to be listed on the Taipei Stock Exchange in December 2024, marking a significant milestone in its mission to advance regenerative medicine and deliver innovative therapies worldwide.

About StemCyte:
StemCyte Inc., a 100%-owned subsidiary of StemCyte International Ltd., is a cell therapy company with a cGMP-certified facility in California, USA. StemCyte's public cord blood stem cell inventory meets the highest international standards, including those of the FDA, EMA, TFDA, AABB, and FACT. This commitment to quality establishes StemCyte as a key supplier in the field of cell therapy and supports the rapid development of allogeneic cell therapy worldwide.

Contact: [email protected]

SOURCE StemCyte