Cellular Therapy Standards

The major objective of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration is to promote quality medical and laboratory practice in cellular therapy and regenerative medicine using hematopoietic-derived cellular products. These Standards apply to:

  • Hematopoietic Progenitor Cells (HPC), defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluri-potent progenitor cells, and committed progenitor cells, regardless of tissue source (bone marrow, umbilical cord blood, peripheral blood, or other tissue source).
  • Mononuclear Cells (MNC), defined as nucleated cells from any tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as hematopoietic progenitor cells.
  • Immune Effector Cells, defined as cells that have differentiated into a form capable of modulating or effecting a specific immune response.
  • Administration of cellular therapy products for hematological disorders and malignancies, including transplants, donor lymphocyte infusions (DLIs), and immune effector cells.
  • All phases of collection, processing, and storage, of HPs and TCs derived from hematopoietic sources, including marrow or peripheral blood. This includes processing with both minimal and more than minimal manipulation, such as removal or enrichment of various cell populations, expansion of hematopoietic cell populations, and cryopreservation.
  • These Standards apply to administration of HPCs or TCs derived from umbilical cord and/or placental blood but not the collection, processing, or banking of these cells. Standards for these processes are found in the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.

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-JACIE 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 and the requirements of the European Union Directives; 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 transplantation program: the Clinical Program, Collection Facility, and Processing Facility. Similar standards were kept consistent across all sections wherever appropriate. 
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