Regulatory issues in cord blood banking and transplantation.

When selecting a cord blood unit for transplantation a transplant program must, in addition to considering HLA match and cell dose, know that the unit is potent, pure and will not transfer an infectious, hematologic or immunologic disease. While these same issues also apply to adult unrelated donors the fact that cord blood has been processed and stored, often years earlier, at a cell processing facility other than the one affiliated with the transplant program has resulted in a transfer of responsibilities from the transplant program to the cord bank. The transplant programs rely on the cord blood banks for all aspects of collection, screening, testing, processing and storage. Additionally the intermediary registries that are responsible for coordinating communications between the banks and transplant programs are important partners in a comprehensive approach to cord blood quality management. Since cord blood units frequently cross international borders it is critical that international regulatory standards be established and implemented to cover all steps in the production and sharing of cord blood for transplantation. Activities of NetCord/FACT, AABB, CIBMTR, World Marrow Donor Association and others are coming together under the Alliance for Harmonization of Cellular Therapy Accreditation to harmonize practice worldwide.