FACT and JACIE Publish Seventh Edition of Hematopoietic Cell Therapy Standards #

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
Purchase Printed Copies

Now Available – Version 1.1 of FACT Standards for Immune Effector Cells #

To promote consistency with the new edition of the FACT-JACIE Standards for Hematopoietic Cell Therapy, Version 1.1 of the FACT Standards for Immune Effector Cells is now available. These requirements will become effective on May 30, 2018. The major objective of these Standards is to promote quality practice in IEC administration. The requirements are for programs that administer IECs on a unit that does not also perform HPC transplantation.  When IECs are administered on a FACT-accredited HPC transplant unit, the program must fully comply with the FACT-JACIE Hematopoietic Cell Therapy Standards.

FACT Standards for Immune Effector Cells, First Edition 1.1
FACT Immune Effector Cell Accreditation Manual, First Edition 1.1
Changes to First Edition FACT Immune Effector Cell Standards
Purchase Printed Copies

FACT Announces Accreditations Awarded in Fourth Quarter of 2017 #

During the fourth quarter of 2017, 37 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.

The Why, What, and How of the New FACT Standards for Immune Effector Cells #

Dr. Sarah Nikiforow, of the Dana Farber Cancer Institute, and Dr. Marcela Maus, of Massachusetts General Hospital, are both members of the FACT Immune Effector Cell Task Force and have written an article published in the Journal of ImmunoTherapy of Cancer, outlining the why, what, and how of the new FACT Standards for Immune Effector Cells.

Drs. Nikiforow and Maus discuss how FACT has established new Standards specific to the use of Immune Effector Cells (IEC), including gene-modified T cells and natural (NK) cells. These Standards specify the clinical and quality infrastructure to facilitate safe administration of immune effector cells and formalize subsequent monitoring and reporting of patient outcomes to enable continual process improvement. The authors detail why these Standards came into being, what they entail, and how a clinical team might access educational materials and implement these Standards. We propose that these Standards will be increasingly useful and relied upon as institutions and clinical service lines seek access to these treatments for their patients.
Read the entire journal article here

Wallchart: Production of Chimeric Antigen Receptor T cells #

Nature Protocols Recipe for Researchers, and Stemcell Technologies, along with Andrew D. Fesnak, Megan M. Suhoski Davis, and Bruce L. Levine, created a comprehensive chart that outlines collection through formulation, delivery, and administration of Chimeric Antigen Receptor T cells (CAR-T cells). This wallchart may be useful to cellular therapy programs for education and procedural development.
Access Wallchart: Production of CAR T Cells here

Bebé Vida is first Cord Blood Bank in Portugal to earn FACT accreditation #

OMAHA, Neb. – Bebé Vida in Portugal received internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. Bebé Vida, directed by Marika Bini Antunes, MD, is the first and only cord blood bank in Portugal to be recognized by FACT. The bank received accreditation on April 28, 2017, and is accredited for banking cord blood for private family use. Read full release

Draft 7th Edition FACT-JACIE Standards Available for Public Comment #

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) have published the draft 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment for a 90-day period. Comments will be accepted from May 1, 2017 through July 30, 2017.

These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood, and administered by a FACT or JACIE-accredited blood and marrow transplant team.
Description and Instructions for FACT-JACIE Standards
Draft FACT-JACIE Standards
Draft FACT-JACIE Manual

To submit comments regarding the draft 7th edition FACT-JACIE Standards, follow the steps below. Comments will be accepted through July 30, 2017.

1. Access the Comment Form at https://www.surveymonkey.com/r/FACT-JACIE.
2. Type in your contact information and comments on the form. Fill in all fields so that the Standards Committee fully understands your position.
3. Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.