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New interim standards to cover administration of immune effector cell products in bone marrow transplantation programmes

posted 2 Feb 2017, 01:41 by Eoin McGrath
FACT and JACIE have 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.

The new standards were initially developed by the FACT Immune Effector Cell Task Force and then JACIE experts were invited to contribute to the final version that is now incorporated into the FACT-JACIE Standards, edition 6.01.

The new editions of the Standards and Manual are attached here. They can also be downloaded from the JACIE website at www.jacie.org/document-centre in the Standards section.

If you are not utilizing any immune effector cell products, these standards do not apply to the transplant program, and you can complete the checklist as “NA” (not applicable) for the new standards.
If your haematopoietic cellular therapy (HCT) transplant program begins using immune effector cells, you must be in compliance with these standards as part of starting the new activity. These aspects will be assessed at the next on-site inspection.
Current accreditation awards do not include the administration of these products.

For any questions, please contact eoin.mcgrath@ebmt.org or telephone +34 93 453 8570 ext. 8101.
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Eoin McGrath,
2 Feb 2017, 04:08
Ċ
Eoin McGrath,
2 Feb 2017, 01:41
Ċ
Eoin McGrath,
2 Feb 2017, 01:41
Ċ
Eoin McGrath,
2 Feb 2017, 04:08
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