A robust quality infrastructure is key to safe and effective delivery of immune effector cells: how FACT-finding can help

Kevin J. Curran, Sarah Nikiforow, Carlos Bachier, Yen Michael Hsu, David Maloney, Marcela V. Maus, Philip McCarthy, David Porter, Patricia Shi, Elizabeth J. Shpall, Basem William, Kara Wacker, Phyllis Warkentin, Helen E. Heslop

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1053-1061
Number of pages9
JournalBlood Advances
Volume8
Issue number4
DOIs
StatePublished - Feb 27 2024

Keywords

  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Lymphocytes

ASJC Scopus subject areas

  • Hematology

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