03023nas a2200337   4500008004100000022004200041245017300083210006900256250001000325260000800335300001300343490000700356520178100363653005402144653006302198653006602261653004002327653004502367653001002412653001202422653007902434653001102513653002002524653001702544653001102561100001902572700001402591700001502605700001602620856004902636       2006                        eng d  a1545-5009 (Print) 1545-5009 (Linking)00aWeighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors0 aWeighing the risks of GCSF administration leukopheresis and stan  a38735  cApr  a422 - 330 v463 aBACKGROUND: 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. PROCEDURE: 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.10a*Bone Marrow Transplantation / ethics / standards10a*Hematopoietic Stem Cell Mobilization / ethics / standards10a*Hematopoietic Stem Cell Transplantation / ethics / standards10a*Leukapheresis / ethics / standards10a*Tissue Donors / classification / ethics10aChild10aeffects10aGranulocyte Colony-Stimulating Factor / *administration & dosage / adverse10aHumans10aRisk Assessment10aRisk Factors10aSafety1 aPulsipher, M A1 aNagler, A1 aIannone, R1 aNelson, R M  uhttps://www.notifylibrary.org/reference/1291