StemCyte, a subsidiary of StemCyte International, announced that the US Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Regenecyte.
Regenecyte is an allogeneic haematopoietic progenitor cell (HPC) cord blood stem cell therapy intended for transplantation in patients with blood and immune system disorders.
It is vital cord blood stem cell therapy derived from human umbilical cord blood.
The product is approved for unrelated donor hematopoietic progenitor cell transplantation in conjunction with the preparative regimen for hematopoietic and immunologic reconstitution.
It is indicated for patients with disorders that affect the haematopoietic system that are inherited, acquired, or result from myeloablative treatment.
With the FDA approval, StemCyte becomes the first commercial US-based biotech company to secure a biologics license for cord blood stem cell therapy.
StemCyte CEO Tong Young Lee said: “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.
“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.”
In addition to Regenecyte, StemCyte is exploring the potential of its other HPC, Cord Blood products for other, emerging therapeutic applications.
The other applications include chronic fatigue syndrome, ageing-related diseases, and other conditions associated with suboptimal health.
The company is also advancing Phase 2 clinical trials of its HPC, Cord Blood product in treating long-COVID and acute stroke, expanding regenerative medicine.
StemCyte is a subsidiary of StemCyte International, a cell therapy company with a cGMP-certified facility in California, US.
StemCyte International is preparing to be listed on the Taipei Stock Exchange in December this year, to advance regenerative medicine and deliver advanced therapies worldwide.
