Accreditation Statistics

As of August 1, 2023

Cellular Therapy Entities

  • Accredited: 255
  • Applicants: 26

Cord Blood Banks

  • Accredited: 53
  • Applicants: 9

Congratulations to the following organizations for achieving initial accreditation:

Pennsylvania Hospital, Penn Medicine: Adult autologous hematopoietic progenitor cellular therapy, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

Sarah Cannon Transplant & Cellular Therapy Program at MountainView Hospital: Adult autologous hematopoietic progenitor cellular therapy, immune effector cellular therapy administration, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

A complete list of accredited organizations can be found at www.factglobal.org.

FACT Submits Comments Regarding Draft FDA Guidance on Regenerative Medicine

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

In November 2017, the FDA released a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies, through the publication of four guidance documents. Two of these documents were finalized, and two are open for public comment.

Draft documents that were open for public comment until February 14, 2018 include:

Related documents published in final form include:

FACT supports the FDA’s efforts to clarify and streamline its regulation of regenerative medicine therapies, and submitted comments organized into two sections: 1) the role of FACT accreditation in advancing cellular therapy for regenerative medicine and 2) specific comments about the guidance documents themselves.