title: Low rate of infusional toxicity after expanded cord blood transplantation.
abstract: OBJECTIVE
  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.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA.
authors.forename: Adham S
authors.initials: AS
authors.lastname: Bear
authors.affiliation: 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.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Hanley
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Doyle M
authors.initials: DM
authors.lastname: Bosque
authors.affiliation: 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.
authors.forename: Conrad R
authors.initials: CR
authors.lastname: Cruz
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Indresh
authors.initials: I
authors.lastname: Kaur
authors.affiliation: Dan L. Duncan Cancer Center, Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital, Houston, Texas, USA.
authors.forename: Hao
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Partow
authors.initials: P
authors.lastname: Kebriaei
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Chitra
authors.initials: C
authors.lastname: Hosing
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Katayoun
authors.initials: K
authors.lastname: Rezvani
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Betul
authors.initials: B
authors.lastname: Oran
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Marcos J
authors.initials: MJ
authors.lastname: De Lima
authors.affiliation: 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.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Bollard
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Shpall
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018929:Cell Culture Techniques / Q000379:methods; D002648:Child; D002675:Child, Preschool; D036101:Cord Blood Stem Cell Transplantation / Q000009:adverse effects*; D005260:Female; D005312:Fetal Blood / Q000166:cytology*; D006085:Graft Survival; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D008297:Male; D008875:Middle Aged
keywords: cell culture; cord blood transplantation, ex vivo expansion