FOR IMMEDIATE RELEASE

December 5, 2025

FACT OFFERS PROVISIONAL CLINICAL ACCREDITATION TO HELP MORE PROVIDERS DELIVER CELL THERAPIES TO ELIGIBLE PATIENTS WHILE MAINTAINING SAFETY AND QUALITY

Consensus-driven pathway helps assure quality and safety in programs new to cell therapy

OMAHA, Neb. - The Foundation for the Accreditation of Cellular Therapy (FACT) today announced the availability of a novel voluntary accreditation pathway intended to increase the availability of transformative cell therapies and bring these therapies closer to where patients live and work.

FACT provisional clinical accreditation requires the same documentation and inspection processes as full accreditation, but can be awarded prior to the provider fulfilling the standard associated with prior treatment of a minimum number of patients.

Over the past year, FACT has actively engaged with a wide range of stakeholders in the cell therapy field to learn what must be done to help more eligible patients receive these potentially curative therapies with assurances of quality and safety. FACT’s leadership re-committed the organization to help expand patient access to cell therapy through collaborative discussion, peer- and consensus-driven action taking, and appropriate urgency.

A recent example of FACT action-taking was publication of its Standards for Immune Effector Cells in the Community Clinical Setting, 1^st edition, developed in part through consensus-driven guidance from the FACT Community CAR T Working Group, who first convened in June of this year.

“Too many eligible patients are not receiving the curative benefits of CAR T. FACT firmly believes that these therapies can and should be available closer to where they live, in safe and quality-focused clinics,” says Dr. Catherine Bollard, President of FACT Board of Directors.

The Community CAR T Working Group, which included representatives from national payer organizations, also identified a significant, real-world challenge facing community providers working to administer CAR T therapies; reimbursement practices. Specifically, providers face substantial financial risk when investing in what’s needed to deliver CAR T therapies safely and effectively, without the assurance of reimbursement.

“FACT’s Standards require that a minimum number of patients be treated prior to the program becoming eligible for FACT accreditation. However, treating patients without the assurance of reimbursement presents significant risk and might prevent eligible patients from receiving these life-changing therapies. Our provisional clinical accreditation addresses the conundrum with the same rigor and requirements everyone expects and can trust from FACT,” says FACT CEO David Schmahl.

“Achieving FACT provisional clinical accreditation signals to all stakeholders the program’s readiness to treat patients with safety and quality at the forefront and should be respected and viewed accordingly,” he adds.

FACT urges all parties interested in learning more about the FACT provisional clinical accreditation to visit here, or to email questions to fact@factglobal.org.