Adham S Bear1, Patrick J Hanley2, Doyle M Bosque3, Conrad R Cruz2, Indresh Kaur3, Hao Liu4, Partow Kebriaei3, Chitra Hosing3, Katayoun Rezvani3, Betul Oran3, Marcos J De Lima3, Catherine M Bollard5, Elizabeth J Shpall3. 1. Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA. 2. Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA; 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. 3. Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA. 4. Dan L. Duncan Cancer Center, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA. 5. Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA; 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. Electronic address: CBollard@childrensnational.org.
Abstract
BACKGROUND AIMS: Umbilical 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. METHODS: We 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. RESULTS: A 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. CONCLUSIONS: We conclude that the infusion of unmanipulated followed by expanded CB products is a safe procedure associated with a low probability of inducing severe reactions.
BACKGROUND AIMS: Umbilical 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. METHODS: We 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. RESULTS: A 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. CONCLUSIONS: We conclude that the infusion of unmanipulated followed by expanded CB products is a safe procedure associated with a low probability of inducing severe reactions.
Authors: T Hahn; U Bunworasate; M C George; A S Bir; W Chinratanalab; A R Alam; B Bambach; M R Baer; J L Slack; M Wetzler; J L Becker; P L McCarthy Journal: Bone Marrow Transplant Date: 2003-07 Impact factor: 5.483
Authors: A L Pecora; P Stiff; A Jennis; S Goldberg; R Rosenbluth; P Price; K L Goltry; J Douville; R D Armstrong; A K Smith; R A Preti Journal: Bone Marrow Transplant Date: 2000-04 Impact factor: 5.483
Authors: M J Laughlin; J Barker; B Bambach; O N Koc; D A Rizzieri; J E Wagner; S L Gerson; H M Lazarus; M Cairo; C E Stevens; P Rubinstein; J Kurtzberg Journal: N Engl J Med Date: 2001-06-14 Impact factor: 91.245
Authors: Marcos De Lima; Lisa S St John; Eric D Wieder; Ming S Lee; John McMannis; Safa Karandish; Sergio Giralt; Miroslav Beran; Daniel Couriel; Martin Korbling; Samer Bibawi; Richard Champlin; Krishna V Komanduri Journal: Br J Haematol Date: 2002-12 Impact factor: 6.998
Authors: T H Truong; R Moorjani; D Dewey; G M T Guilcher; N L Prokopishyn; V A Lewis Journal: Bone Marrow Transplant Date: 2016-01-11 Impact factor: 5.483