The approval makes the company the first commercial biotech to receive such a license for this cell therapy type.
Derived from the umbilical cord blood of humans, the allogeneic hematopoietic stem cell therapy REGENECYTE is currently approved for use in unrelated donor hematopoietic progenitor cell transplantation.
The therapy is intended for patients with hematopoietic system disorders, whether inherited, acquired, or resulting from myeloablative treatments.
It is administered alongside an appropriate preparative regimen for immunologic and hematopoietic reconstitution.
Umbilical cord blood, which is rich in potent stem cells, can be used in transplants to treat various kinds of diseases, such as blood disorders, cancer, and the disorders of immune system.
StemCyte CEO Dr 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.”
The company’s portfolio extends beyond REGENECYTE, as it explores the potential of its other HPC, Cord Blood products for a range of therapeutic applications.
These include aging-related diseases, chronic fatigue syndrome, and other conditions related to health.
The ongoing Phase II clinical trials for the treatment of long COVID syndrome and acute stroke are being conducted by the company.
As a wholly owned subsidiary of StemCyte International, StemCyte operates a current good manufacturing practice (cGMP)-certified facility in the US.