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 U.S.-based biotech company to secure a biologics license for cord blood stem cell therapy, offering a new treatment option for patients with blood and immune system disorders.
REGENECYTE: A Novel Approach to Hematopoietic Reconstitution
REGENECYTE™ is an allogeneic hematopoietic stem cell therapy derived from human umbilical cord blood. It is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures. The therapy aims to facilitate hematopoietic and immunologic reconstitution in patients with inherited or acquired disorders affecting the hematopoietic system, as well as those undergoing myeloablative treatment.
Expanding Therapeutic Horizons
Beyond REGENECYTE™, StemCyte is actively exploring the potential of its other HPC, Cord Blood products for various emerging 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 efficacy of HPC, Cord Blood in treating long COVID syndrome and acute stroke, demonstrating its commitment to regenerative medicine.
StemCyte's Strategic Vision
"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. He added, "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. anticipates listing on the Taipei Stock Exchange in December 2024, a move that will further support its mission to advance regenerative medicine and deliver innovative therapies globally.
About StemCyte
StemCyte Inc., a wholly-owned subsidiary of StemCyte International Ltd., operates a cGMP-certified facility in California, USA. The company's public cord blood stem cell inventory adheres to the highest international standards, including those set by the FDA, EMA, TFDA, AABB, and FACT. This dedication to quality positions StemCyte as a key supplier in the cell therapy field and supports the advancement of allogeneic cell therapy worldwide.
