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
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.