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A robust quality infrastructure is key to safe and effective delivery of immune effector cells: how FACT-finding can help.
Curran, Kevin J; Nikiforow, Sarah; Bachier, Carlos; Hsu, Yen-Michael; Maloney, David; Maus, Marcela V; McCarthy, Philip; Porter, David; Shi, Patricia; Shpall, Elizabeth J; William, Basem; Wacker, Kara; Warkentin, Phyllis; Heslop, Helen E.
Afiliação
  • Curran KJ; Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
  • Nikiforow S; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
  • Bachier C; Sarah Cannon Transplant and Cellular Therapy Program, St. David's Austin Medical Center, Austin, TX.
  • Hsu YM; Department of Medicine, Division of Hematology and Oncology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA.
  • Maloney D; Division of Hematology and Oncology Fred Hutchinson Cancer Research Center, Seattle WA.
  • Maus MV; Cellular Immunotherapy Program Massachusetts General Hospital, Boston MA.
  • McCarthy P; Department of Medicine, Transplant and Cellular Therapy Program Roswell Park Comprehensive Cancer Center, Buffalo, NY.
  • Porter D; Division of Hematology/Oncology, Department of Medicine and Abramson Cancer Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
  • Shi P; New York Blood Center Clinical Apheresis and Cellular Therapy Laboratory, New York, NY.
  • Shpall EJ; Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • William B; OhioHealth Blood and Marrow Transplant Program, OhioHealth, Columbus, OH.
  • Wacker K; Foundation for the Accreditation of Cellular Therapy, Omaha, NE.
  • Warkentin P; Foundation for the Accreditation of Cellular Therapy, Omaha, NE.
  • Heslop HE; Pathology/Microbiology, University of Nebraska Medical Center, Omaha, NE.
Blood Adv ; 8(4): 1053-1061, 2024 Feb 27.
Article em En | MEDLINE | ID: mdl-37467016
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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante de Células-Tronco Hematopoéticas Tipo de estudo: Diagnostic_studies / Guideline Limite: Humans Idioma: En Revista: Blood Adv Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante de Células-Tronco Hematopoéticas Tipo de estudo: Diagnostic_studies / Guideline Limite: Humans Idioma: En Revista: Blood Adv Ano de publicação: 2024 Tipo de documento: Article