The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023

BALDWIN PARK, CA, USA I March 22, 2022 I The BLA (Biologics License Application) for the “HPC-Cord Blood” product, was submitted to FDA on January 7th, 2022, and StemCyte was officially notified on March 8th, 2022, that the submission was acceptable to enter the biologics license quality review process.

The “HPC-Cord Blood” is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system. Since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988, there have been more than 40,000 successful umbilical cord blood transplants worldwide for the treatment of diseases of the hematopoietic and immune systems as well as inborn metabolic diseases.

In the past 20 years, StemCyte has provided more than 2,200 cord blood units for transplantation.

In the past 20 years, StemCyte has provided more than 2,200 cord blood units for transplantation to 1 in 20 patients worldwide who receive umbilical cord blood transplants. StemCyte’s products consistently meet the quality standards of international accrediting bodies and are recognized and trusted as safe and effective by at least 350 transplant centers around the world including such well-known medical centers as: Duke University Hospital, UCLA Medical Center, Taiwan Chang Gung Memorial Hospital, National Taiwan University Hospital.

StemCyte is a regenerative cell therapy company that is developing cell therapy pipeline products as well as providing both public and private umbilical cord blood banking services. In addition to the US FDA approved Phase II multi-national and multi-center human clinical trial for its investigational spinal cord injury treatment, the cell therapy product lines also include several other human clinical trials in progress outside the US for treatment of acute ischemic stroke, chronic stroke, and cerebral palsy. Development of a cancer immunotherapy is planned to begin this year. StemCyte’s cord blood bank is multi-ethnic with the matching rate for patients from different ethnic groups relatively high compared with other public cord blood banks. StemCyte considers umbilical cord blood banking its core competence, while actively pursuing new regenerative cell therapy indications. StemCyte’s mission is to continue to develop its unique cord blood banking capabilities to achieve the goal of delivering lifesaving therapies to patients who suffered degenerative and other life-threatening diseases.

SOURCE: StemCyte