FDA-Approved Cord Blood Product
REGENECYTE® (HPC, Cord Blood), a cord blood product developed by StemCyte, received U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) in November 2024.
REGENECYTE® is licensed under BLA No. 125764 and U.S. License No. 2280 and is currently listed among the FDA’s Approved Cellular and Gene Therapy Products.
This approval demonstrates that StemCyte has established manufacturing, quality control, and regulatory systems for REGENECYTE® that meet U.S. requirements for licensed biological products. It also reflects StemCyte’s capabilities in advancing cord blood resources beyond long-term banking and clinical supply toward the development of standardized cellular products.
REGENECYTE® is an FDA-approved cord blood-derived hematopoietic progenitor cell product developed by StemCyte. It is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment, for the purpose of hematopoietic and immunologic reconstitution.
REGENECYTE® Receives U.S. FDA Biologics License Approval
In November 2024, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for REGENECYTE®, StemCyte’s cord blood product, and issued U.S. License No. 2280.
According to the FDA approval information, the Proper Name of REGENECYTE® is HPC, Cord Blood. StemCyte, Inc. is the applicant and manufacturer, and the licensed manufacturing facility is located in Baldwin Park, California, USA.
| Product Name | REGENECYTE® |
| FDA Proper Name | HPC, Cord Blood |
| Applicant and Manufacturer | StemCyte, Inc. |
| BLA / STN | 125764 |
| U.S. License No. | 2280 |
| Approval Date | November 20, 2024 |
| Approval Type | Biologics License Application, BLA |
| Licensed Manufacturing Facility | Baldwin Park, California, USA |
| Approved Indication | Hematopoietic and Immunologic Reconstitution in Unrelated Donor Hematopoietic Progenitor Cell Transplantation |
REGENECYTE® is currently listed among the U.S. FDA’s Approved Cellular and Gene Therapy Products.
FDA-Approved Indication for REGENECYTE®
According to the U.S. FDA-approved indication, REGENECYTE® may be used in 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 that are inherited, acquired, or result from myeloablative treatment.
Cord blood hematopoietic stem cell transplantation is currently used clinically to treat nearly 80 diseases, including cancers, blood disorders, immune system disorders, and metabolic disorders. Whether cord blood transplantation is appropriate for an individual patient depends on the type of disease, the patient’s condition, cell matching results, and the professional assessment of the medical team.
REGENECYTE® should be evaluated and administered by a medical team experienced in hematopoietic stem cell transplantation, based on the patient’s condition, the product’s FDA-approved labeling, and applicable medical standards and guidelines.
From Cord Blood Banking to Standardized Cellular Products
Obtaining FDA BLA approval represents more than the approval of a regulatory application. It reflects a comprehensive body of data covering product specifications, manufacturing processes, quality control, testing methods, process validation, product release and stability, as well as the safety and efficacy data supporting the application.
Donor and Cell Source Management → Cord Blood Processing and Storage → Quality Testing → Process Validation and Product Release → Regulatory Review → Clinical Supply
StemCyte has capabilities extending beyond cord blood banking and global clinical supply. The company has also established practical expertise in manufacturing, quality management, and regulatory submissions for cord blood products in accordance with approved specifications. These capabilities provide an important foundation for StemCyte’s continued advancement of cellular product development, clinical research, and international collaboration.
Frequently Asked Questions (FAQ)
Yes. REGENECYTE® (HPC, Cord Blood), StemCyte’s cord blood product, received U.S. FDA BLA approval in 2024. Its BLA/STN is 125764, and its U.S. License No. is 2280.
REGENECYTE® is a human cord blood-derived hematopoietic progenitor cell product developed by StemCyte. Its FDA Proper Name is HPC, Cord Blood, and it is an allogeneic cellular biologic product.
The FDA has approved REGENECYTE® for use in unrelated donor hematopoietic progenitor cell transplantation procedures, in conjunction with an appropriate preparative regimen, for hematopoietic and immunologic reconstitution.
BLA stands for Biologics License Application, the application submitted to the U.S. FDA for authorization to market a biological product. Once a BLA is approved, the applicant may legally distribute the biological product in the United States in accordance with the FDA-approved product, manufacturing facility, indication, and labeling.