#United States #StemCyte #REGENECYTE #FDA Approval #Baldwin Park

FDA Approves StemCyte's REGENECYTE

StemCyte Inc., a subsidiary of StemCyte International Ltd., has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving its biologics license application for REGENECYTE™, a cord blood-derived stem cell therapy. This approval positions StemCyte as a key player in the regenerative medicine sector, especially in treating blood and immune system disorders.

A Breakthrough in Cord Blood Therapy

The REGENECYTE™ product is an allogeneic hematopoietic stem cell therapy sourced from human umbilical cord blood intended for transplantation in patients suffering from hematopoietic disorders. These include conditions that are inherited, acquired, or arise due to myeloablative treatments. The approval allows for its use in unrelated donor hematopoietic progenitor cell transplantation, providing crucial therapeutic options for those battling severe health challenges.

With this milestone, StemCyte becomes the 15th organization in 2024 and the first commercial biotech firm in the USA to receive such a license for cord blood stem cell therapy, underlining the significance of this achievement in the realm of biotechnology.

Exploring New Frontiers in Regenerative Medicine

Beyond REGENECYTE™, StemCyte is actively researching other cord blood products to fulfill emerging therapeutic needs, including treatments for chronic fatigue syndrome, age-related diseases, and issues linked to compromised health. The company is also advancing its Phase II clinical trials to assess the efficacy of HPC, Cord Blood in addressing long COVID syndrome and acute strokes.

Commitment to Innovation

Dr. Tong Young Lee, CEO of StemCyte, lauded the approval, emphasizing the company's robust inventory of cord blood stem cells, which positions it well to continue leading in cell therapy products' manufacture and development. Lee’s statements reflect a commitment to driving innovative therapies and achieving sustainable growth through diversified business strategies.

As StemCyte prepares for its anticipated listing on the Taipei Stock Exchange in December 2024, the company underscores its mission to push the boundaries of regenerative medicine and deliver transformative therapies worldwide.

About StemCyte

StemCyte's manufacturing facility in California, USA, meets stringent international standards from bodies such as the FDA, EMA, TFDA, AABB, and FACT. This adherence to quality positions the company as a vital supplier in cell therapy and supports the rapidly growing demand for allogeneic treatments global landscape.

In an era where regenerative medicine is gaining momentum, StemCyte's advancements with REGENECYTE™ and other cord blood therapies are set to make a tremendous impact on patient care and treatment efficacy. As the field of regenerative medicine continues to evolve, the approval showcases a hopeful future for patients requiring innovative therapies to combat their medical conditions.