The seventh edition of the FACT-JACIE Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been published. FACT-accredited hematopoietic progenitor cell (HPC) transplantation programs must be in compliance with these Standards by May 30, 2018. 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.

The major objective of these Standards is to promote quality medical and laboratory practice in HPC transplantation and related therapies using hematopoietic-derived cellular products. These Standards apply to:

  • HPCs, and nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs.
    • For HPCs or mononuclear cells derived from umbilical cord or placental blood, these Standards apply only to the administration of the cellular therapy product. Standards for cord blood collection and banking are available in a separate document, the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, available at www.factwebsite.org.
  • Immune effector cells (IECs) derived from hematopoietic sources, defined broadly as any cells, in vitro modified or not, that are capable of eliciting or modulating an immune response.
    • Stand-alone immune effector cell therapy programs that do not perform HPC transplantation should reference the FACT Standards for Immune Effector Cells

FACT-JACIE Hematopoietic Cell Therapy Standards, Seventh Edition
FACT-JACIE Accreditation Manual, Seventh Edition
Changes to Seventh Edition FACT-JACIE Standards
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