FACT was founded in 1995 to promote quality patient care and laboratory practice in hematopoietic cell transplantation through its program of professional standards and voluntary accreditation for the procurement, processing, and transplantation of hematopoietic cell products.

FACT is the accreditation arm of two professional societies dedicated to improvement and progress in cellular therapy: the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell & Gene Therapy (ISCT). ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. Established in 1992, ISCT is the global steward fostering cell and gene therapy translation to the clinic. ISCT members have a shared vision to translate cell and gene therapies into safe and effective therapies to improve patients’ lives worldwide. ASTCT is an international professional association whose mission is dedicated to improving the application and success of blood and marrow transplantation and related cellular therapies. ASTCT strives to be the leading organization promoting research, education and clinical practice in the field.

Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, these two organizations merged their standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation), which formed the foundation for the first edition of FACT Standards. The two societies established FACT in order to develop a voluntary inspection and accreditation program based on the joint Standards.

Recognizing the importance of developing consensus Graft Processing Standards, in 1994 the North American Task Force (NATF) was formed consisting of all the major professional organizations interested in hematopoietic cell therapy, including ISCT, ASTCT, and FACT. There was general consensus that the FACT Standards were of sufficiently high quality to serve as a template for the other organizations involved in this field.

The FACT inspection and accreditation program was developed by Dr. Phyllis Warkentin, FACT Chief Medical Officer, in conjunction with the FACT Board of Directors and the ISCT and ASTCT regulatory and standards committees.

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