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 firstname.lastname@example.org.
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.