Stemcyte First Biotech to Receive FDA Approval of a Cord Blood Derived Cellular Therapeutic

FDA Grants Approval to StemCyte for REGENECYTE™ Cord Blood Cell Therapy

StemCyte Inc., a subsidiary of StemCyte International Ltd., has achieved a landmark in regenerative medicine with the U.S. Food and Drug Administration’s (FDA) approval of its Biologics License Application (BLA) for REGENECYTE™. Announced on November 22, 2024, this cord blood derived cellular therapeutic is designed to treat patients with blood and immune system disorders, making StemCyte the first commercial biotech company to receive a biologics license for a cord blood stem cell therapy.

REGENECYTE™, the 9th Cord Blood Product Approved by FDA

REGENECYTE™, derived from human umbilical cord blood, is an allogeneic hematopoietic stem cell therapy. It has been approved by the U.S. FDA for unrelated donor hematopoietic progenitor cell transplants in patients undergoing preparative regimens for disorders of the hematopoietic system, whether inherited, acquired, or due to myeloablative treatments.

This approval makes REGENECYTE™ the ninth cord blood therapy product endorsed by the FDA. Previous approvals of cord blood derived cellular therapeutics include:

1. Allocord: Developed by SSM Cardinal Glennon Children’s Medical Center
2. Clevecord: Developed by Cleveland Cord Blood Center
3. Ducord: Developed by Duke University School of Medicine
4. Hemacord: Developed by New York Blood Center
5. HPC, Cord Blood: Developed by Clinimmune Labs at the University of Colorado
6. HPC, Cord Blood – MD Anderson Cord Blood Bank: Developed by MD Anderson Cancer Center
7. HPC, Cord Blood – LifeSouth: Developed by LifeSouth Community Blood Centers
8. HPC, Cord Blood – Bloodworks: Developed by Bloodworks

As explained in StemCyte’s recent press announcement, its ambitions extend beyond transplantation. The company is actively investigating the potential of its cord blood products for emerging therapies targeting conditions like chronic fatigue syndrome, age-related diseases, and other health challenges. Promising research includes Phase II clinical trials exploring the use of cord blood stem cells to treat long COVID syndrome and acute stroke.

“StemCyte possesses one of the world’s largest inventories of cord blood stem cells,” remarked Dr. Tong Young Lee, CEO of StemCyte. “Our mission is to innovate therapies, sustain growth through diverse strategies, and establish ourselves as global leaders in cell therapy.”

A Global Footprint in Regenerative Medicine

StemCyte International Ltd. is set to list on the Taipei Stock Exchange in December 2024, marking another milestone in its journey to advance regenerative medicine globally. Operating from its cGMP-certified facility in California, the company adheres to rigorous standards set by the FDA, EMA, TFDA, AABB, and FACT. This commitment reinforces its role as a leading supplier and innovator in the cell therapy domain.

Through REGENECYTE™ and its broader portfolio, StemCyte continues to push the boundaries of regenerative medicine, delivering hope to patients and advancing the possibilities of stem cell therapies worldwide.

To learn more about this rapidly expanding field, view the “Global Cord Blood & Tissue Banking Industry Report – Market Size, Segmentation, & Forecasts, 2024.”