These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
These Standards are intended to be flexible to accommodate various models of patient care and use of cellular therapy products. Requirements for programs that administer immune effector cells on a unit that is not already FACT-accredited are contained fully in the FACT Immune Effector Cell Standards. When immune effector cells are administered on a FACT-accredited blood and marrow transplant (BMT) unit, the program must fully comply with the FACT-JACIE Hematopoietic Cell Therapy Standards.
Every effort has been made in these Standards to incorporate sound recommendations fostering quality medical and laboratory practice in cellular therapy and regenerative medicine. However, no standards can guarantee the successful outcome of such therapies. FACT Standards are minimal performance guidelines that may be exceeded as deemed appropriate by the responsible personnel in individual facilities. Attempts have been made to conform these Standards to existing U.S. federal regulations; however, compliance with these Standards does not guarantee compliance with all regulations. In all cases, personnel must follow all applicable laws and regulations.
The Standards are structured to align similar standards among the three primary functions within a cellular therapy program: the Clinical Program, Collection Facility, and Processing Facility. Similar standards were kept consistent across all sections wherever appropriate.