About FACT

Founded in 1996, FACT establishes standards for high quality medical and laboratory practice in cellular therapies. FACT is a non-profit corporation co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.
Over 90% of all eligible US facilities and programs are FACT accredited.
The only international standard used in Europe, Canada, Australia, New Zealand and the USA.

The Leader in International Standards for Cellular Therapy

FACT Standards are evidence-based requirements set by world-renowned experts vested in the improvement and progress of cellular therapy. Standards for Hematopoietic Progenitor Cells (HPC) and and other nucleated cells
obtained from bone marrow, peripheral blood, and umbilical and placental cord blood are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts who represent the entire continuum of cell manufacturing and administration. With unparalleled depth and breadth, the Standards trace the entire life of a cell product from donor selection to collection, processing, storage, release, and ultimately administration to a patient.
Learn More about FACT Standards  

The Leader in Peer Review Accreditation

The voluntary FACT accreditation program is founded upon a network of peers helping each other improve cellular therapy practices. Rigorous and comprehensive inspections are balanced with a collegial approach that encourages organizations to reach minimum standards for the benefit of patients. Inspectors are volunteers who are international experts in their field with current and practical knowledge of the intent of the requirements. Multiple levels of review and oversight ensure accreditation is awarded consistently, thoroughly, and objectively based upon the international standards. Organizations that achieve FACT accreditation have developed and implemented a foundation of high-quality practices that result in cell products and patient care that are sought after by physicians and patients. 
Learn More about FACT Accreditation

Phyllis Warkentin 2015

"FACT is committed to high quality patient care and laboratory practice in cellular therapies, and believes that the Standards, the expertise of our inspectorate, and the depth and breadth of our inspection and accreditation program will help ensure high quality of all units and desirable outcomes for patients."

Phyllis I. Warkentin, MD - FACT Chief Medical Officer


The International Society for Cell and Gene Therapy 

ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients.  Since 1992, ISCT has been the leading global forum for developing and supporting innovative cellular therapies through communication, education and training.

The American Society for Transplantation and Cellular Therapy 

ASTCT is an international professional association that promotes the advancement of the blood and marrow transplantation field. ASTCT members are both in clinical practice and in research.



FACT Consulting

Accreditation Success Story

Quality is The Standard at M.D. Anderson Cancer Center. M. D. Anderson Cancer Center is recognized as No. 1 in cancer care in U.S. News & World Report's annual "America's Best Hospitals" survey, in part due to our FACT accreditation. Read more