StemCyte Inc., a subsidiary of StemCyte International Ltd., has received FDA approval for its Biologics License Application (BLA) for REGENECYTE™, a cord blood stem cell therapy. This approval marks StemCyte as 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. The therapy is intended for use 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.
Expanding Therapeutic Horizons
Beyond REGENECYTE™, StemCyte is investigating the potential of its other HPC, Cord Blood products for various therapeutic applications. These include chronic fatigue syndrome, aging-related diseases, and other conditions associated with suboptimal health. The company is also conducting Phase II clinical trials to assess the use of HPC, Cord Blood in treating long COVID syndrome and acute stroke.
Leadership Perspective
"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."
Future Directions
StemCyte International Ltd. is expected to be listed on the Taipei Stock Exchange in December 2024. This listing is a significant step in the company's mission to advance regenerative medicine and deliver innovative therapies globally.
About StemCyte
StemCyte Inc. operates a cGMP-certified facility in California, USA. Its public cord blood stem cell inventory adheres to international standards, including those of the FDA, EMA, TFDA, AABB, and FACT. This commitment to quality positions StemCyte as a key supplier in the cell therapy field.
