Hematopoietic Cell Therapy Standards

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

Cellular Therapy Accreditation Process Requirements

The scope of the FACT-JACIE Standards includes:

• Hematopoietic progenitor cells (HPCs), defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluripotent progenitor cells, and committed progenitor cells, regardless of tissue source (bone marrow, umbilical cord blood, peripheral blood, or other tissue source).
• Nucleated cells or mononuclear cells from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as HPCs. These cells may be further enumerated, identified by CD designation or other methodology, or may be used in further manufacturing of cellular therapy products for administration.
• Immune effector cells (IECs), defined as cells, in vitro modified or not, that have differentiated into a form capable of modulating or effecting a specific immune response. This broad designation includes cellular therapy products with widely diverse manufacturing methods, constructs, clinical indications, and safety and toxicity profiles. Individual programs and responsible personnel must understand the immune effector cell products in clinical use, the spectrum and timing of potential and anticipated toxicities associated with each product or type of product, implement relevant risk evaluation and mitigation strategies, and apply these Standards appropriately to each situation.
• Genetically modified cells, defined as cells that have been modified by replacing a disease-causing gene with a health copy of the gene, inactivating a disease-causing gene that is not functioning properly, or introducing a new or modified gene into the body to help treat a disease.

For cellular therapy products derived from umbilical cord or placental blood, these Standards apply only to the clinical administration of the product, applying the relevant clinical and processing standards for product preparation and administration. Standards for cord blood collection and banking are available in a separate document, NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, available here: CBB Standards.

These Standards incorporate sound principles of quality medical and laboratory practice in cellular therapy. However, no standards can guarantee the successful outcome of such therapies. FACT-JACIE Standards are minimal guidelines that may be exceeded as deemed appropriate by the responsible personnel in individual facilities. Directors and Medical Directors assume responsibility for adopting FACT-JACIE Standards as appropriate to the program, and for setting more rigorous internal requirements where appropriate. Attempts have been made to conform these Standards to existing United States federal regulations and the requirements of the European Union Directives; however, compliance with these Standards does not guarantee compliance with all applicable regulations.