JACIE has successfully completed its first-ever inspection under the 3rd Edition Immune Effector Cells (IEC) Standards at Guy's and St Thomas' NHS Foundation Trust (London, UK).
This milestone marks the operational launch of JACIE’s dedicated IEC certification pathway for programmes delivering immune effector cell therapies outside of a Stem Cell Transplantation setting.
A new certification pathway for a rapidly expanding field
Immune effector cell therapies — including CAR-T cells, CAR-NK cells, tumour-infiltrating lymphocytes (TILs), and dendritic cell vaccines — are rapidly expanding across oncology, autoimmune diseases, and advanced clinical trial environments. As these therapies move beyond traditional transplant programmes, the need for a dedicated quality and certification framework has become increasingly important.
The FACT-JACIE IEC Standards, Third Edition (Version 3.1), which entered into effect on 2 February 2026, were developed specifically to address the operational realities and quality requirements of IEC programmes.
Importantly, this certification pathway is open to programmes administering IEC therapies that do not perform haematopoietic stem cell transplantation.
What does the certification cover?
The IEC certification pathway covers the full continuum of IEC therapy delivery, including:
- Patient selection and clinical care
- Collection activities
- Manufacturing and/or coordination with manufacturing partners
- Receipt and handling of the final cellular product
- Administration of IEC therapies
- Post-infusion monitoring and management of toxicities
- Long-term follow-up
The Standards also place particular emphasis on areas critical to IEC therapies, including:
- Chain-of-identity and chain-of-custody
- Coordination with commercial and external manufacturers
- Recognition and management of IEC-specific toxicities
- Cross-functional programme coordination and governance
Who can apply?
The pathway is designed for a broad range of programmes delivering IEC therapies, including:
- Oncology and haemato-oncology units
- Autoimmune disease programmes
- Immunology and cellular therapy units
- Clinical trial facilities
- Standalone IEC centres
The pathway is independent from the HCT certification.
Why pursue JACIE IEC Certification?
JACIE certification provides programmes with an internationally recognised quality framework designed to support:
- Patient safety and quality of care
- Standardisation of complex cellular therapy processes
- Readiness for regulatory and clinical expansion
- Strengthened multidisciplinary coordination
- Demonstration of quality to patients, partners, and stakeholders
- Continuous improvement and benchmarking against international standards
The successful pilot inspection at Guy's and St Thomas' NHS Foundation Trust demonstrated that the new certification process is practical, achievable, and ready for broader implementation across the IEC community. As cellular therapies continue to expand into new clinical areas, JACIE is uniquely positioned to bring its longstanding expertise in quality, certification, and patient safety to programmes beyond Haematopoietic Cellular Therapy.
Resources
Centres interested in pursuing certification are encouraged to review the available resources and contact the JACIE Office (jacie@ebmt.org) for guidance on eligibility and the application process.
Useful resources:
- FACT-JACIE IEC Standards, Third Edition (Version 3.1)
- Frequently Asked Questions (FAQs)
- Webinar “Key Changes and Updates in the 9th Edition of HCT and 3rd Edition IEC Standards”. Recording available to both JACIE Inspectors and Centre staff involved or interested in JACIE certification on the EBMT e-learning platform.
- Press release “New JACIE IEC Certification pathway opens the door for centres beyond transplant”
Next steps
EBMT and JACIE invite eligible centres worldwide — including oncology units, autoimmune disease programmes, clinical trial facilities, and standalone IEC centres — to apply for certification and join this important step forward in ensuring excellence in cellular therapy delivery.
For further information, please contact the JACIE team at Jacie@ebmt.org