Hematopoietic Cell Procurement, Processing, and Transplantation: Standards, Accreditation, and Regulation

Hematopoietic cells obtained from bone marrow, peripheral blood, and placental and umbilical cord blood cells are common graft sources derived from autologous, related, or unrelated donors. Rapid evolution of cellular therapies has heightened concern about the safety, purity, potency, and efficacy of cellular products. Under the authority of the Public Health Services Act and the Federal Food, Drug, and Cosmetic Act, the government, through the Food and Drug Administration (FDA), is empowered to enact binding legislation related to cellular therapy products. Some states in the U.S., such as New York, have adopted specific regulations for processing of and storage facilities for HCT/Ps. Others like, Massachusetts and Maryland, require accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) to perform hematopoietic cell transplantation within those states. All FACT Standards are developed by consensus of world-renowned experts active in cellular therapy.