Regulation of hematopoietic stem cell processing and transplantation.

The widespread use of tissue including hematopoietic stem cell products is justification for the development of standards by professional societies and for regulation by governmental agencies. The Food and Drug Administration (FDA) developed a tiered, risk-based regulatory model. At the low end of risk to the tissue recipient, the regulations being developed by the FDA are comparable to standards developed by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and recognize a basic level of practice in the collection, processing, and distribution of hematopoietic stem cell (HSC) products. This basic level of practice, when fully enacted, will be found in part 1,271 of chapter 21 of the Code of Federal Regulations (CFR), which includes criteria for facility management, quality control, donor selection, and the processing of cells. The regulatory approach adopted by the FDA is more comprehensive than FAHCT standards, however. It defines higher levels of regulatory oversight that combines appropriate sections of part 1271 with current good manufacturing practice requirements described in parts 210, 211, and 820 of chapter 21 of the CFR for HSC products that are more than minimally manipulated.