The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) have published a preliminary draft of both the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT 9 Standards) and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC). These drafts are now open for public comments which will be accepted until 15 December 2024.
The objective of the FACT-JACIE HCT Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and other cellular therapies. The scope of the Standards includes but is not limited to hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use, immune effector cells (IECs), and genetically modified cells.
The objective of the FACT-JACIE IEC Standards is to promote quality medical and laboratory practice in the field of immune effector cell therapy. Immune effector cells are defined as cells, in vitro modified or not, that have differentiated or been manufactured into a form capable of modulating or effecting a specific immune response, including T cells, tumour infiltrating lymphocytes, natural killer cells, dendritic cells, and mesenchymal stromal cells. Final products include, but are not limited to, genetically modified chimeric antigen receptor T cells (CAR-T cells), CAR-NK cells, and dendritic cell vaccines. The broad designation includes cellular therapy products with widely diverse manufacturing methods, constructs, clinical indications, and safety and toxicity profiles.
The field of cellular therapy is continuously evolving, and our goal for each new edition of the Standards is to accurately capture and reflect those changes to remain a relevant and useful resource for programs. The comments, suggestions, and feedback solicited during the public comment period are not only welcome, but vital to ensuring that we achieve this goal. Participating in our public comment survey is a direct way to make your thoughts known because each comment is reviewed by the Standards Committee. Additionally, responses to the comments received during this period will be published alongside the final version of the Standards.
The review for both the HCT and IEC Standards includes multiple structural and content changes for which we are requesting specific comments. These include:
- A single collection section was created in the HCT Standards which includes apheresis, marrow, and other tissue sources. This change was introduced to reflect advances in the field and incorporate evolving cell collection types and practices.
- Standards and edits introduced to standardise practices related to Risk Evaluation and Mitigation Strategies (REMS).
- New Standards recommending a Chain of Identity Identifier (C7.1.3, C7.3.2, C7.3.5, D7.1.3, and D7.3.2) to be assigned before or at the time of collection to each collection intended for further manufacturing.
- The Standard for Processing Facility Director qualifications (Standard D3.1.1) has not changed. The committee proposed guidance to consider a pathway for people who do not possess a doctoral level degree to serve as the director.
- New audit requirements were added in Clinical, Collection, and Processing Standards 4.8.4 through 4.8.6.
The published draft includes a redlined document intended to highlight the changes made to these Standards. Minor changes to the organisation or phrasing (including edits to correct or improve grammar and punctuation) of the document may not be tracked. Some of the highlighted changes are new standards; others are intended to clarify rather than change the intent of existing standards. In addition, many changes were made to harmonise the language and provide greater consistency among all sets of FACT-JACIE Standards.
The draft HCT and IEC Standards are available at the bottom of this page.
There are two surveys. Complete the HCT survey if your comments are related to HCT and/or IEC practice. Complete the IEC survey if your comments are related to IEC only practice. Additional instructions can be found in the surveys at HCT and IEC Surveys.
There is no limit to the number of comments you can submit. This survey allows you to enter up to thirty (30) comments per section. If you wish to provide additional comments, please start a new survey.
For questions regarding the survey, please contact Monique Summers-Currington, FACT Standards Development Manager at Monique.Summers@factglobal.org
For any JACIE-related queries, please contact Tuula Rintala, Quality of Care and Advocacy Director, at tuula.rintala@ebmt.org