Standards

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.

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.

Public Review and Comment

Comments from the public regarding the current Standards and/or Accreditation Manuals may be submitted at any time. Intermittently, it is necessary update the Standards or Accreditation Manuals based on changes to applicable laws and regulations, field experience, or other reasons. FACT has a process to accommodate needed changes between editions which can be found in the Establishing and Reviewing Standards Policy.
FACT Standards Available for Public Review and Comment >

International Standards for Hematopoietic 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. 
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Standards for Immune Effector Cells

These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines. (Transplant programs that also administer immune effector cell programs should refer to the FACT-JACIE Hematopoietic Cell Therapy Standards for a complete set of requirements pertaining to both HPC transplant and immune effector cells.)
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International Standards for Cold 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.
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Common Standards for Cellular Therapies

These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. The Common Standards can be used to improve cellular therapy programs utilizing non-hematopoietic cells or treating non-hematological diseases.
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