FACT News

Summary of 13th Cell Therapy/FDA Liaison Meeting Now Available #

The FDA CTLM Meeting, on October 19, 2016, addressed several hot topics in cellular therapy. Representatives from the cellular therapy field and from the FDA presented information on each of the topics. A summary of these presentations, and the presentation slides, are now available.
Read Final Meeting Summary

News Release: FACT Publishes First Edition of Immune Effector Cell Standards #

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NEWS RELEASE
Issued: February 3, 2017
Contact: Linda Miller


OMAHA, Neb. – The Foundation for the Accreditation of Cellular Therapy (FACT) is pleased to announce it has published standards for immune effector cells. The new requirements, included within interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration and within the new, first edition FACT Standards for Immune Effector Cells, apply to 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.Read full release

FACT Publishes First Edition of Immune Effector Cell Standards #

The first edition of the FACT Standards for Immune Effector Cells has been published.  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. (Compliance with the immune effector cell standards by March 1, 2017 is required of FACT-accredited programs performing this type of therapy.) Stand-alone immune effector cell therapy programs should reference the FACT Immune Effector Cell Standards. Applications for accreditation of these programs will be accepted in February. More details will be forthcoming. 

The scope of the Standards includes donor selection and management, administration of cells, management of adverse events, and evaluation of clinical outcomes. The Standards require a quality management (QM) program that establishes, maintains, monitors, and implements improvements in the quality of facilities, processes, and performance.

These Standards were prepared with the understanding that some programs will be responsible for collection and processing of immune effector cells. Regardless of where the product comes from, the program must meet clearly defined responsibilities for chain of custody, storage, verification of product identity, and management of adverse events. To the extent that a program is responsible for collection of cells, manufacturing of the cellular therapy product, or preparing the product for administration; the collection and processing requirements in the FACT Immune Effector Cell Standards apply. 

FACT Standards for Immune Effector Cells
Immune Effector Cell Accreditation Manual
Frequently Asked Questions
Purchase Printed Copies


Now Available – Interim FACT-JACIE Standards for Immune Effector Cells #

Through the work of the Immune Effector Cell Task Force, led by Co-Chairs Dr. Helen Heslop, Dr. EJ Shpall, and Dr. Michael Lill, FACT has published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration. The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others. The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.

These requirements will become effective on March 1, 2017. All FACT-accredited cellular therapy programs that administer immune effector cells must be in compliance with the new standards by this date. If you have any questions, contact the FACT office at fact@unmc.edu.

The updated Standards, accompanying Accreditation Manual, and summary of changes are available on the FACT website for reference. Printed copies of the Standards and Accreditation Manual may be purchased from the FACT store.

FACT-JACIE Hematopoietic Cell Therapy Standards
Cellular Therapy Accreditation Manual
Changes to 6th Edition FACT-JACIE Standards and Accreditation Manual
Frequently Asked Questions
Purchase Printed Copies


FACT Announces Accreditations Awarded in Second Half of 2016 #

During the second half of 2016, 48 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

StemCyte India Therapeutics is first Cord Blood Bank in India to earn FACT accreditation #

OMAHA, Neb. – StemCyte India Therapeutics in India received internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.  Read full release

FACT Announces Accreditations Awarded in First Half of 2016 #

During the first half of 2016, 28 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.




		
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