Stemcyte First Biotech to Receive FDA Approval of a Cord Blood Derived Cellular Therapeutic - https://lnkd.in/gWe8xJps
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.
Derived from human umbilical cord blood, REGENECYTE™ 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 9th 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
“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.”