FACT-accredited cellular therapy programs have demonstrated compliance with the applicable FACT 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 services they provide under the applicable FACT Standards as defined below.
CELLULAR THERAPY STANDARDS
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration:
Scope: Hematopoietic progenitor cells and nucleated cells, including mononuclear cells and immune effector cells, from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood). Also apply to immune effector cells when collected, processed, or administered by a blood and marrow transplant (BMT) unit.
FACT Standards for Immune Effector Cells
Scope: Immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells (e.g., genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines). When immune effector cells are administered on a FACT-accredited BMT unit, the program must fully comply with the FACT-JACIE Hematopoietic Cell Therapy Standards.
FACT Common Standards for Cellular Therapies
Scope: Basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application; intended for use throughout product development and clinical trials. Ideally, various discipline-specific or product specific standards would be added in the future with the input, collaboration, and acceptance of those experts actively involved in the specific field. These Common Standards are not intended to suffice for hematopoietic cellular therapy programs, immune effector cellular therapy programs, or cord blood banks, which are all within the scope of the more specific sets of FACT Standards.
Hematopoietic Progenitor Cell Transplantation
A Clinical Program that is responsible for all aspects of patient care and treatment involved with 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.
- Autologous - Cells are taken from one individual and transplanted back into the same individual.
- Allogeneic - Cells are taken from one individual and transplanted into another genetically distinct individual.
Immune Effector Cellular Therapy
A Clinical Program that is responsible for all aspects of patient care and treatment involved with the administration of immune effector cells.
A facility where cellular therapy products are collected from a donor using the following procedure(s):
- Marrow - 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 - 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 using the following types of manipulation:
- Minimal Manipulation - Processing that does not alter the relevant biological characteristics of cells or does not alter the original relevant characteristics of structural tissue relating to the tissue's utility for reconstruction, repair, or replacement.
- More than Minimal Manipulation - Processing that does alter the relevant biological characteristics of cells or does alter the original relevant characteristics of structural tissue relating to the tissue's utility for reconstruction, repair, or replacement.
A facility that is independently FACT accredited to provide collection or processing services to a cellular therapy program.