Top

Information about the Immune Effector Cells (IEC) certification

FACT-JACIE Standards HCT 9th edition and IEC 3rd edition define Immune effector cells (IECs) as ‘cells, in vitro modified or not, that have differentiated 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 (CART cells), CAR-NK cells, and dendritic cell vaccines’. This broad designation includes cellular therapy products with widely diverse manufacturing methods, constructs, clinical indications, and safety and toxicity profiles. Donor lymphocyte infusions (DLI) are not considered IECs for the purposes of the FACT-JACIE standards.  

Please see below some FAQs. For any other questions please contact us at jacie@ebmt.org

What is the difference between the Standards for Hematopoietic Cellular Therapy (9.1 Edition) and the Standards for Immune effector cells (3.1 Edition)?

Both the Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (9.1 Edition) and the Standards for Immune effector cells (3.1 Edition) include all requirements for programs administering immune effector cell therapies.  

However, whereas the HCT Standards cover both HCT and IEC administration and related activities, the IEC Standards exclude all requirements specific for HCT only.

Which Standards will my programme be certified against?

There are currently two JACIE Certification pathways: 

  • The HCT Pathway: For HCT programmes that include (or not) the administration of Immune Effector Cells (IECs). 

      Applicable Standards: FACT-JACIE International Standards for Hematopoietic Cellular Therapy (9th Edition, 9.1). 

  • The IEC Pathway: Designed exclusively for programmes administering immune effector cellular therapies outside of a transplant setting. This includes for example, Clinical Trials Facilities, IEC Facilities, Oncology / autoimmune disease units.  

      Applicable Standards: FACT-JACIE International Standards for Immune Effector Cells (3rd Edition, 3.1). 

My Centre is a transplant programme and we will start administering IEC soon. How can I certify the new IEC activity?

If a centre wishes to seek certification for administration of IECs, this can be done in 2 ways: 

  1. Include this activity when applying for the first time or at the time of recertification
    1. When a centre undergoing inspection for Initial certification or Recertification requests the inclusion of IEC in the scope of the certification application, the Clinical inspector will be inspecting all activities of the Clinical programme (HCT + IEC).  
  1. Include this activity within the scope of a current certification
    1. When a currently-certified centre wishes to expand the scope of their certification to include IEC, JACIE will perform a focussed reinspection, usually expected to take up to 1 day with 2 inspectors. 

 

 

What aspects of IEC activities will be inspected?

When a JACIE inspection of a HCT programme includes the IEC scope, JACIE inspectors will verify that the programme complies with all applicable standards for both Haematopoietic Cell Transplantation (HCT) and Immune Effector Cell (IEC) activities. This includes the administration, collection and processing, when done within the programme. If IEC products are manufactured by a third-party facility, JACIE inspectors will not evaluate the external manufacturer. Instead, they will assess the programme’s responsibilities, such as: 

  • Interactions with the manufacturer 
  • Formal agreements and contracts 
  • Oversight and communication processes 
  • Programme-specific IEC handling activities 

Many standards apply to both HCT and IEC (e.g., access to intensive care), and inspectors will review these with specific attention to their relevance for IEC services. 

Is there a minimum amount of activity required for IEC certification?

Yes. Minimum activity requirements apply to IEC certification. For the first time, the 9th Edition of the HCT Standards introduces a requirement for a minimum level of clinical activity in Immune Effector Cell therapy, defined as at least three (3) new patients treated with immune effector cells prior to initial certification and annually thereafter, applicable to each clinical site. Further details are provided in Appendix I.  

Similarly, the 3rd Edition of the IEC Standards establishes a higher minimum activity threshold, requiring five (5) new patients treated with immune effector cell therapy prior to initial certification and annually thereafter, as outlined in Appendix I. 

Is there a cost?

IEC activity is charged a supplementary fee the same as when different patient populations are treated within the same programme. This is to cover the additional inspection workload and associated back-office costs.

How can I become an inspector for Immune Effector Cells?

If you are interested in becoming an inspector, please contact inspectors@ebmt.org. Please also see JACIE's criteria to be an inspector here.