ESTABLISHING GLOBAL STANDARDS IN CELLULAR THERAPIES

The FACT Standards promote improvement and progress in cellular therapy and regenerative medicine. Meeting these requirements demonstrates a commitment to controlling every aspect that impacts the quality of products and therapeutic care. With regular updates through the collaboration of the most knowledgeable minds in cellular therapy, the depth and breadth of FACT Standards are unmatched. These international requirements instill confidence in cellular therapy products from FACT accredited organizations around the world.

About the FACT Standards

The Standards are the cornerstone of the FACT accreditation program. Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, the FACT Standards are the only set of requirements that emphasize the clinical use of cellular therapy products collected and processed with rigorous controls. The Standards currently apply to Hematopoietic Progenitor Cells (HPC) and other nucleated cells obtained from hematopoietic sources, such as marrow, peripheral blood, and umbilical cord blood, including those processed with minimal or more than minimal manipulation.

FACT Standards are evidence-based requirements set by international teams of world-renowned experts vested in the improvement and progress of cellular therapy. Standards are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts that span the entire continuum of cell manufacturing. International leaders in cellular therapy programs, cord blood banks, and registries serve on the Standards Development Committees. Liaison representation from consumers and regulatory bodies are consulted throughout the development process. This results in detailed, comprehensive Standards that address each aspect of cell manufacturing and administration that impacts the quality of products and therapeutic care.

The Standards are based upon published medical evidence whenever possible. When published data is not available, requirements are based upon accepted scientific theory. The development process includes a period for public review and comment, legal review, and approval by the FACT Board of Directors.

International Standards for Cellular Therapy Product Collection, Processing, and Administration

These Standards apply to cellular therapy programs that collect, process, or administer hematopoietic-derived cells including organizations that provide support for such services. These requirements address collection and processing of cells isolated from marrow or peripheral blood. They also apply to facilities that prepare cells derived from cord blood for administration, and the clinical units that administer them, after receiving the cells from a cord blood bank..Obtain Cellular Therapy Standards

International Standards for Cord Blood Collection, Banking, and Release for Administration

These Standards apply to cord blood banks that perform cord blood donor management and collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution.  Obtain Cord Blood Standards

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As a Matter of FACT

Almost all FACT operations are created and implemented through committees of volunteer experts.

Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more