FACT-accredited Cellular Therapy Programs have demonstrated compliance with the current FACT Cellular Therapy Standards. The accreditation process involves the submission of documentation to demonstrate compliance with the standards and a subsequent on-site inspection conducted by inspectors qualified by training and experience in cellular therapy. Accredited organizations have met rigorous standards, as defined by the leading experts in the field and based on the latest knowledge of the field of cellular therapy product transplantation. Organizations are accredited for the types of transplants they perform or the services they provide.
Clinical program that is responsible for all aspects of patient care and treatment, including the administration of cells with the intent of providing transient or permanent engraftment in support of therapy of disease.
- Adult – An adult patient as defined by the program.
- Pediatric – A pediatric patient as defined by the program.
- Auto – Autologous transplant: Cells are taken from one individual and transplanted back into the same individual.
- Allo – Allogeneic transplant: Cells are taken from one individual and transplanted into another genetically distinct individual.
Facility where cellular therapy products are collected from a donor.
- Marrow – Marrow collection: the collection of material that contains immature and mature blood cells, including white blood cells, red blood cells, and platelets from the interior of a large bone of a donor.
- Peripheral blood by Apheresis – Peripheral blood collected by apheresis as a source of hematopoietic progenitor cells and/or other mononucleated cells.
A facility where cellular therapy product processing activities are performed.
- Processing – All aspects of manipulation, cryopreservation, packaging, and labeling of cellular therapy products regardless of source. This accreditation was divided into two accreditation goals (minimal and/or more than minimal manipulation) in 2012.
- Minimal – Minimal Manipulation: Processing that does not alter the relevant biological characteristics of cells.
- More than Minimal – More than Minimal Manipulation: Processing that does alter the relevant biological characteristics of cells.