Standards

FACT accredits facilities under four sets of international standards. The FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration apply to hematopoietic progenitor cell transplantation. The requirements apply to all phases of collection, processing, storage, and administration of these cells. For cells collected from umbilical cord and/or placental blood, these Standards apply only to the administration of the cord blood unit.

The NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration apply to facilities and individuals performing donor recruitment and eligibility determination and cord blood collection, processing, testing, cryopreservation, storage, banking, listing, search, selection, reservation, release, and distribution. They include requirements for cord blood units intended for unrelated and related use.

The FACT Common Standards for Cellular Therapies promote quality medical and laboratory practice in a broad range of cellular therapies. The Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. These Standards apply to cells collected from non-hematopoietic sources (e.g., adipose tissue) and cells collected from hematopoietic sources for non-homologous use (e.g., mesenchymal stromal cells for cardiac repair).

The FACT Standards for Immune Effector Cells 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 chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines. The scope of the Standards includes donor selection and management, administration of cells, management of adverse events, and evaluation of clinical outcomes. These Standards are intended to be flexible to accommodate various models of patient care and use of cellular therapy products.

FACT Standards are developed by international teams of experts in the field of cellular therapy and cord blood banking. The Standards Committee sets these requirements by consensus, believing that these at a minimum must be met to achieve quality programs. Standards are updated every three years based on the rapidly evolving field; feedback from inspectors, committees, and staff; and input from related organizations.