title: Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors.
abstract: BACKGROUND
  Granulocyte colony stimulating factor (G-CSF) is used for collection of hematopoietic cells in most adult and a smaller but significant percentage of pediatric normal donor harvests. Short and long-term risks of G-CSF administration and leukopheresis are not well understood in the pediatric population.
  
  
  METHODS
  Literature review including observations from the IBMTR, NMDP, EBMT, German Donor Registry, and the authors' work.
  
  
  RESULTS
  G-CSF causes temporary discomfort in a minority of younger donors. Rare serious side effects of G-CSF have yet to be reported in children. To date, an increase in hematological malignancies after short-term G-CSF use has not been detected in adult donors and no cases have been reported in children. Reported complications of leukopheresis in children are rare and minor, but donors <20 kg may be exposed to allogeneic blood products. Pediatric aged donors vary widely in their ability to assent or consent to the risks of a donation procedure. There are key regulations and ethical imperitives, which must be addressed in deciding which donation procedures are appropriate for minors.
  
  
  CONCLUSIONS
  While short term administration of G-CSF and leukopheresis appear to be safe and effective procedures when used to assist in collection of a hematopoietic cell graft from a normal pediatric donor, institutions adding or substituting one or both of these procedures for standard marrow donation must decide whether the donor should be considered a research subject, and if so, whether the new procedures are a minor increase over minimal risk. Because these procedures are being performed on and off study at many pediatric centers, a comprehensive study addressing donor safety could help clarify risks of rare adverse events.
authors.affiliation: Primary Children's Medical Center, Salt Lake City, Utah 84113, USA. michael.pulsipher@hsc.utah.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pulsipher
authors.forename: Arnon
authors.initials: A
authors.lastname: Nagler
authors.forename: Robert
authors.initials: R
authors.lastname: Iannone
authors.forename: Robert M
authors.initials: RM
authors.lastname: Nelson
mesh_terms: D016026:Bone Marrow Transplantation / Q000941:ethics / Q000592:standards; D002648:Child; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization / Q000941:ethics / Q000592:standards; D018380:Hematopoietic Stem Cell Transplantation / Q000941:ethics / Q000592:standards; D006801:Humans; D007937:Leukapheresis / Q000941:ethics / Q000592:standards; D018570:Risk Assessment; D012307:Risk Factors; D012449:Safety; D014019:Tissue Donors / Q000145:classification / Q000941:ethics
chemical_list: D016179:Granulocyte Colony-Stimulating Factor