TY - JOUR
T1 - A robust quality infrastructure is key to safe and effective delivery of immune effector cells
T2 - how FACT-finding can help
AU - Curran, Kevin J.
AU - Nikiforow, Sarah
AU - Bachier, Carlos
AU - Hsu, Yen Michael
AU - Maloney, David
AU - Maus, Marcela V.
AU - McCarthy, Philip
AU - Porter, David
AU - Shi, Patricia
AU - Shpall, Elizabeth J.
AU - William, Basem
AU - Wacker, Kara
AU - Warkentin, Phyllis
AU - Heslop, Helen E.
N1 - Publisher Copyright:
© 2024 by The American Society of Hematology.
PY - 2024/2/27
Y1 - 2024/2/27
N2 - Immune effector cells (IECs) include a broad range of immune cells capable of modulating several disease states, including malignant and nonmalignant conditions. The growth in the use of IECs as both investigational and commercially available products requires medical institutions to develop workflows/processes to safely implement and deliver transformative therapy. Adding to the complexity of this therapy are the variety of targets, diseases, sources, and unique toxicities that a patient experiences following IEC therapy. For over 25 years, the Foundation for the Accreditation of Cellular Therapy (FACT) has established a standard for the use of cellular therapy, initially with hematopoietic cell transplantation (HCT), and more recently, with the development of standards to encompass IEC products such as chimeric antigen receptor (CAR)-T cells. To date, IEC therapy has challenged the bandwidth and infrastructure of the institutions offering this therapy. To address these challenges, FACT has established a programmatic framework to improve the delivery of IEC therapy. In this study, we outline the current state of IEC program development, accreditation, and solutions to the challenges that programs face as they expand their application to novel IEC therapy.
AB - Immune effector cells (IECs) include a broad range of immune cells capable of modulating several disease states, including malignant and nonmalignant conditions. The growth in the use of IECs as both investigational and commercially available products requires medical institutions to develop workflows/processes to safely implement and deliver transformative therapy. Adding to the complexity of this therapy are the variety of targets, diseases, sources, and unique toxicities that a patient experiences following IEC therapy. For over 25 years, the Foundation for the Accreditation of Cellular Therapy (FACT) has established a standard for the use of cellular therapy, initially with hematopoietic cell transplantation (HCT), and more recently, with the development of standards to encompass IEC products such as chimeric antigen receptor (CAR)-T cells. To date, IEC therapy has challenged the bandwidth and infrastructure of the institutions offering this therapy. To address these challenges, FACT has established a programmatic framework to improve the delivery of IEC therapy. In this study, we outline the current state of IEC program development, accreditation, and solutions to the challenges that programs face as they expand their application to novel IEC therapy.
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U2 - 10.1182/bloodadvances.2023010401
DO - 10.1182/bloodadvances.2023010401
M3 - Review article
C2 - 37467016
AN - SCOPUS:85187725049
SN - 2473-9529
VL - 8
SP - 1053
EP - 1061
JO - Blood Advances
JF - Blood Advances
IS - 4
ER -