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Low rate of infusional toxicity after expanded cord blood transplantation
Institution:1. Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital, and Texas Children''s Hospital, Houston, Texas, USA;2. Dan L. Duncan Cancer Center, Baylor College of Medicine, The Methodist Hospital, and Texas Children''s Hospital, Houston, Texas, USA;3. Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research, and Sheikh Zayed Institute for Pediatric Surgical Innovation, Children''s National Health System, Washington, DC, 20010;4. Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA;1. Centre de Recherche du CHU Ste-Justine, Université de Montréal, Montréal, Québec, Canada;2. Département de Pharmacologie, Université de Montréal, Montréal, Québec, Canada;3. Département de Somatologie, Université de Montréal, Montréal, Québec, Canada;1. Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People''s Hospital, Shanghai, China;2. Shanghai Key Laboratory of Orthopedic Implants, Department of Orthopedics, Ninth People''s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;1. Clinica Medica I, Fondazione IRCCS Policlinico San Matteo, Università di Pavia, Pavia, Italy;2. Istituto Scienze dell''Alimentazione, CNR Avellino, Italy;3. Dipartimento di Bioscienze, Università di Parma, Italy (currently affiliated with Dipartimento di Biochimica e Biologia Molecolare, Università di Parma, Italy; Dipartimento di Medicina Occupazionale, Ergonomia e Disabilità, Laboratorio di Nanotecnologia, Fondazione IRCCS Salvatore Maugeri, Università di Pavia, Italy);4. Laboratorio di Nanotecnologia, Fondazione IRCCS Salvatore Maugeri, Università di Pavia, Italy (currently affiliated with Dipartimento di Medicina Occupazionale, Ergonomia e Disabilità, Laboratorio di Nanotecnologia, Fondazione IRCCS Salvatore Maugeri, Università di Pavia, Italy; Dipartimento di Medicina Molecolare, Centro di Ingegneria Tissutale, INSTM UdR Pavia, Università di Pavia, Italy);5. Servizio di Endoscopia Digestiva, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;6. Servizio di Immunogenetica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;7. Dipartimento di Onco-Ematologia Pediatrica e Medicina Trasfusionale, Ospedale Bambino Gesù, Roma e Università degli Studi di Pavia, Pavia, Italy;8. Servizio di Biometria e Statistica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Abstract:Background aimsUmbilical cord blood (CB) is used with increasing frequency to restore hematopoiesis in patients with bone marrow transplant who lack a suitable human leukocyte antigen–matched donor. CB transplantation is limited by low cell doses and delays in neutrophil and platelet engraftment. CB progenitors expanded ex vivo before transplantation provide more rapid hematopoietic and immune reconstitution as well as less engraftment failure compared with unmanipulated CB. However, the safety of infusing double and ex vivo–expanded CB has not been systematically examined.MethodsWe reviewed the immediate adverse events (AE) associated with the infusion of CB occurring within 24 hours in 137 patients enrolled in clinical CB transplant trials at the MD Anderson Cancer Center from February 2004 to May 2010. All patients received an unmanipulated CB unit followed by infusion of a second unmanipulated CB unit or a second CB unit expanded ex vivo with the use of cytokines in a liquid culture system or in mesenchymal stromal cell co-cultures.ResultsA total of three grade 2 and two grade 3 infusion reactions occurred within 24 hours of CB transplantation. This resulted in an AE rate of 3.7%. The majority of AEs manifested as signs of hypertension. No association with patient age, sex, disease status, premedication, ABO compatibility or total infusion volume was observed. In summary, the incidence of infusion-related toxicities in patients who receive unmanipulated and ex vivo–expanded double CB transplantation is low.ConclusionsWe conclude that the infusion of unmanipulated followed by expanded CB products is a safe procedure associated with a low probability of inducing severe reactions.
Keywords:cell culture  cord blood transplantation  ex vivo expansion
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