International Certification and Quality Systems
StemCyte is committed to maintaining the highest standards of quality. Both StemCyte U.S. and StemCyte Taiwan complete annual Human Cell and Tissue Establishment Registration with the U.S. Food and Drug Administration (FDA). StemCyte Taiwan also undergoes regular inspections by the Taiwan Food and Drug Administration (TFDA) and is licensed as a Human Organ Bank.
In addition, StemCyte U.S. and StemCyte Taiwan regularly undergo professional inspections by independent international organizations. These include AABB (Association for the Advancement of Blood & Biotherapies) and FACT (Foundation for the Accreditation of Cellular Therapy), two key accreditations for cord blood banks, as well as NMDP and WMDA.
FDA Human Cell and Tissue Establishment Registration
The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by regulating the safety of drugs, biological products, medical devices, food, cosmetics, and radiation-emitting products. Under Section 361 of the U.S. Public Health Service Act, establishments that manufacture human cells, tissues, and cellular and tissue-based products are required to register with the FDA and renew their registration annually in December.
Both StemCyte Taiwan and StemCyte U.S. maintain FDA Human Cell and Tissue Establishment Registration in accordance with stringent quality standards.
TFDA Human Organ Bank License
In 2009, Taiwan’s Ministry of Health and Welfare promulgated the Regulations Governing the Management of Human Organ Banks, requiring organizations engaged in the processing or storage of human organs—including human tissues, cells, and their derivatives—for transplantation purposes to obtain approval to establish a Human Organ Bank.
StemCyte Taiwan’s cord blood bank successfully passed the TFDA Human Organ Bank on-site inspection in 2009. Since then, it has undergone TFDA on-site inspections every three years and has consistently complied with applicable Good Tissue Practice requirements for human organs, tissues, and cells.
AABB — Association for the Advancement of Blood & Biotherapies
AABB (Association for the Advancement of Blood & Biotherapies) is a globally recognized accreditation organization in transfusion medicine and biotherapies. More than 80% of cord blood banks in the United States have obtained AABB accreditation. AABB conducts on-site assessments every two years to evaluate whether cord blood banks meet stringent quality and safety standards.
StemCyte Taiwan’s cord blood bank has maintained AABB accreditation since 2004, successfully completing the rigorous biennial on-site assessment process.
FACT — Foundation for the Accreditation of Cellular Therapy
FACT (Foundation for the Accreditation of Cellular Therapy) is an internationally recognized accreditation organization that establishes independent standards covering the entire cord blood process, from collection, processing, testing, storage, and release to clinical administration. Its accreditation is widely recognized as a leading quality standard in the field of cellular therapy and transplantation.
StemCyte Taiwan’s cord blood bank obtained FACT accreditation in 2012 and remains the only FACT-accredited cord blood bank in Taiwan.
NMDP — National Marrow Donor Program
NMDP operates one of the world’s largest registries and search platforms for unrelated bone marrow and cord blood hematopoietic stem cell donors, providing matching and search services for transplant physicians and patients worldwide. Cord blood banks must successfully complete NMDP’s rigorous documentation review and on-site assessment process to become members of the NMDP network.
StemCyte Taiwan’s cord blood bank became an NMDP member in 2003. Through the NMDP network, StemCyte Taiwan has provided more than 30 publicly donated cord blood units for transplantation in patients in the United States, France, Germany, Denmark, and Spain.
WMDA — World Marrow Donor Association
The World Marrow Donor Association (WMDA) facilitates access to hematopoietic stem cell resources worldwide, enabling transplant patients to search for, match with, and access suitable stem cell products. The WMDA network currently includes nearly 800,000 cord blood units from 55 countries.
StemCyte Taiwan has worked closely with WMDA since its establishment and has registered nearly 10,000 publicly donated cord blood units. Together, StemCyte Taiwan and StemCyte U.S. have registered more than 30,000 publicly donated cord blood units.
ISBT 128 International Standard
ISBT 128 is a global standard for the terminology, identification, labeling, and information processing of medical products of human origin. Developed and managed by ICCBBA (International Council for Commonality in Blood Banking Automation), it applies to human-derived products including blood, cord blood, stem cells, tissues, and organs.
The ISBT 128 system provides each cord blood and stem cell product with a unique identifier, enhancing safety and traceability in clinical use. The standard has been widely adopted by healthcare systems in more than 87 countries worldwide.
Red Blood Cell Non-Depletion Processing Technology
Cord Blood Stem Cell Packaging and Transportation Technology
Cord Blood-Based Technology for HIV Treatment
Cord Blood Stem Cell Technology for the Treatment of Brain Injury
