Promote patient safety and access, and protect the research environment
FACT's Immune Effector Cell (IEC) Standards and accreditation promotes patient safety and access, protects the research environment, and assists health care entities with establishing a quality and sustainable program.
Notable Publications
Building a Program:
Bringing CAR T-Cell Therapies to Community Oncology Practices
Simmons G. (2025)In Pursuit of Optimal Outcomes: A Framework for Quality Standards in Immune Effector Cell Therapy
Dandoy C, et al. (2024). doi: 10.1016/j.jtct.2024.07.011A Robust Quality Infrastructure is Key to Safe and Effective Delivery of Immune Effector Cells – How “FACT”-Finding Can Help
Curran KJ, et al. (2023). doi: 10.1182/bloodadvances.2023010401Driving the CAR to the Bone Marrow Transplant Program
Hema D, Jerkins L, et al. (2019). doi: 10.1007/s11899-019-00544-6American Society for Blood and Marrow Transplantation Pharmacy Special Interest Group Survey on Chimeric Antigen Receptor T Cell Therapy Administrative, Logistic, and Toxicity Management Practices in the United States
Mahmoudjafari Z, Haws KG, et al. (2019). doi: 10.1016/j.bbmt.2018.09.024Building a CAR Garage: Preparing for the Delivery of Commercial CAR T Products at Memorial Sloan Kettering Cancer Center
Perica K, et al. (2018). doi: 10.1016/j.bbmt.2018.02.018The Why, What, and How of the New FACT Standards for Immune Effector Cells
Maus MV, Nikiforow S. (2017). doi: 10.1186/s40425-017-0239-0
Harmonizing Cellular Therapy Systems:
Awakening from REMS: ASTCT 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells
Locke F, et al. (2025). doi: 10.1016/j.jtct.2025.02.009The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy Ordering and Scheduling, and Cell Collection
Mora A, et al. (2023). doi: 10.1016/j.jtct.2023.08.011Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies
Nikiforow S, et al. (2023). doi: 10.1016/j.jtct.2023.01.021
Establishing Guidelines:
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome
Hines MR, et al. (2023). doi: 10.1016/j.jtct.2023.03.006Introduction to How I Treat Series on Emergent CAR T-Cell Toxicities
Heslop HE. (2023). doi: 10.1182/blood.2023020228How I Treat Refractory CRS and ICANS After CAR T-Cell Therapy
Jain MD, et al. (2023). doi: 10.1182/blood.2022017414How I Treat Cytopenias After CAR T-Cell Therapy
Jain T, et al. (2023). doi: 10.1182/blood.2022017415How I Treat Unique and Difficult-to-Manage Cases of CAR T-Cell Therapy-Associated Neurotoxicity
Santomasso BD, et al. (2023). doi: 10.1182/blood.2022017604How I Approach Optimization of Patients at Risk of Cardiac and Pulmonary Complications After CAR T-Cell Therapy
Gutierrez C, et al. (2023). doi: 10.1182/blood.2022017579Immune Effector Cell-Associated Hematotoxicity: EHA/EBMT Consensus Grading and Best Practice Recommendations
Rejeski K, et al. (2023). doi: 10.1182/blood.2023020578ASBMT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells
Lee DW, et al. (2018). doi: 10.1016/j.bbmt.2018.12.758Chimeric Antigen Receptor T-cell Therapy – Assessment and Management of Toxicities
Neelapu SS. (2017). doi: 10.1038/nrclinonc.2017.148Building a Safer and Faster CAR: Seatbelts, Airbags and CRISPR
Perales MA, et al. (2017). doi: 10.1016/j.bbmt.2017.10.017
Collecting Cells for Further Manufacturing:
Secondary Cancers after Chimeric Antigen Receptor T-Cell Therapy
Verdun N, Marks P. (2024). doi: 10.1056/NEJMp2400209A guide to the collection of T-cells by apheresis for ATMP manufacturing—recommendations of the GoCART coalition apheresis working group
Worel N, et al. (2023). doi: 10.1038/s41409-023-01957-xConsiderations for immune effector cell therapy collections: a white paper from the American Society for Apheresis
Liu H, et al. (2022). doi: 10.1016/j.jcyt.2022.02.007Optimizing leukapheresis product yield and purity for blood cell-based gene and immune effector cell therapy
Shi PA. (2020). doi: 10.1097/MOH.0000000000000611
Manufacturing Immune Effector Cells:
Production of Chimeric Antigen Receptor T Cells
Fesnak AD, et al. (2017). Nature America, Inc., part of Springer Nature
Educational Resources
Selected On-Demand FACT Education and Downloads:
Tumor Infiltrating Lymphocytes
Parameswaran P, Mullinax J. (2023)CAR-T Cells and T-Cell Receptor Cells in Solid Tumors
Frigault M, Kebriaei P. (2023)FACT Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors: General Concepts and Need for Harmonization of Standards
William B, Nikiforow S. (2022)Integration of Immune Effector Cellular Therapy Into a FACT Accredited Transplant Program
Bachier C. (2020)Bringing a Stand-Alone Immune Effector Cellular Therapy Program into FACT Compliance
Shpall EJ, et al. (2020)