Kara Wacker, MBA, RAC
ISCT North America LRA Committee
Foundation or the Accreditation of Cellular Therapy
United States
Tuula Rintala
European Society for Blood and Marrow Transplantation (EBMT)
Spain
FACT and JACIE Publish Updates to Hematopoietic Cell Therapy and Immune Effector Cell Standards; FACT Announces Inaugural Edition of Standards for IECs in the Community Clinical Setting.
FACT and JACIE have officially released the Standards for Hematopoietic Cellular Therapy (HCT), 9th Edition and the Standards for Immune Effector Cells (IEC), 3rd Edition — setting the global benchmark for excellence in cellular therapy.
What's New?
- Updated International Standards for HCT and IEC
- Fresh Accreditation Manuals to guide your journey
- Downloadable Summary of Changes and Resources for HCT and IEC related documents to keep you informed
The Standards and their accompanying Accreditation Manuals are now available in the FACT store.
An overview of the key changes and updates in the latest editions of these standards was presented in an informative webinar, “FACT-JACIE HCT Standards 9th Edition and IEC 3rd Edition,” on October 29, 2025. If you were unable to attend the live session, register for the on-demand recording.
The HCT and IEC Standards embody FACT and JACIE’s enduring commitment to advancing quality, patient safety, and excellence in the medical and laboratory practice of cellular therapy worldwide.
For questions regarding the Standards, please contact FACT at standards@factglobal.org
FACT also published the Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition, to help community oncology programs deliver transformative cell therapies closer to where eligible patients live and work.
“These Standards, and FACT’s accompanying voluntary accreditation, will help assure community-based caregivers, patients, and all stakeholders that the patient journey will be grounded in quality and safety,” says Dr. Catherine Bollard, President of the FACT Board of Directors.
While familiarity with and use of cell therapies continues to grow among physicians, demand still exists for clear and consistent information. In a 2024 survey from IQVIA, ~70% of referring physicians said they would benefit from more, or a lot more, information about cell therapy. These Standards respond to that need.
“FACT spent several months inviting feedback from a wide range of stakeholders in cell and gene therapy, and took action with the appropriate urgency,” says FACT CEO David Schmahl. “We’ll continue to listen and respond to the needs of providers, patients, and other stakeholders.”
Development began last spring when FACT convened the Community CAR T Working Group, comprised of community-based physicians, leaders from academic medical centers, and representatives of medical societies. The Community IEC Standards adapt the FACT-JACIE International Standards for Immune Effector Cells, 3rd edition, to meet the “fit for purpose” needs of community-based oncology programs.
“Currently, many patients eligible for cellular therapy must be referred for treatment to hospitals far away from where they live, often resulting in the treatment not being received. We must expand access for treatment much closer to where these patients live. These Standards help community oncology programs do this, with relevant guidance addressing quality and safety through the patient journey,” says Working Group member Michael Byrne DO (Tennessee Oncology).
“FACT is committed to expanding patient access and working with community oncology programs to see that care happens safely and with quality at the forefront,” added Schmahl.
FACT urges all parties interested to access these Standards and be part of the solution to bring these transformative therapies to more patients.
The JACIE Perspective
After three years of intensive collaborative work, the publication of FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT 9) and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC 3) represents a significant milestone for the cellular therapy community.
These updated Standards embody both organisations' ongoing commitment to promoting quality medical and laboratory practice in hematopoietic progenitor cell transplantation and cellular therapies. As the cellular therapy field continues its rapid evolution, these new editions capture the latest advances and best practices, ensuring they remain relevant and valuable resources for programs worldwide. This commitment to quality has never been more critical in safeguarding patient safety, ensuring product quality, and protecting staff involved in the collection, storage, and administration of these products.
Developing these two sets of Standards has been a comprehensive undertaking, requiring dedication, expertise, and countless hours of collaborative effort across the globe. We extend our heartfelt thanks to the Standards Steering Committee for their strategic leadership and oversight throughout this extensive revision process. Their vision and guidance have been instrumental in bringing these updated Standards to fruition. Lively discussions occurred at every stage, including the review of more than 1,000 public comments. For the first time, the comments, decisions taken, and the rationale for those decisions will be published and shared with stakeholders after the Standards documents are released.
We are equally grateful to the Sub-Committee Chairs and all Sub-Committee members who led the detailed review and revision work across the Clinical, Collection, Processing, IEC, and Quality Management domains. Their expertise and commitment to excellence have ensured that every aspect of the Standards reflects current best practice and field experience. Their clinical and laboratory expertise, thoughtful contributions, and rigorous review have been essential to developing Standards that are both comprehensive and practical.
Both editions of the Standards were published 28th October 2025, accompanied by Standards Manuals that will explain the intent of the Standards and include examples of the evidence required by inspectors during inspections. The Standards and the associated documents are available for free on https://www.ebmt.org/jacie/jacie-standards.
These Standards will continue to serve as the cornerstone of JACIE and FACT programs worldwide, helping cellular therapy programs maintain the highest standards of patient care and laboratory practice.
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