Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors

Pediatr Blood Cancer. 2006 Apr;46(4):422-33. doi: 10.1002/pbc.20708.

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.

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.

Publication types

  • Review

MeSH terms

  • Bone Marrow Transplantation* / ethics
  • Bone Marrow Transplantation* / standards
  • Child
  • Granulocyte Colony-Stimulating Factor / administration & dosage*
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Hematopoietic Stem Cell Mobilization* / ethics
  • Hematopoietic Stem Cell Mobilization* / standards
  • Hematopoietic Stem Cell Transplantation* / ethics
  • Hematopoietic Stem Cell Transplantation* / standards
  • Humans
  • Leukapheresis* / ethics
  • Leukapheresis* / standards
  • Risk Assessment
  • Risk Factors
  • Safety
  • Tissue Donors* / classification
  • Tissue Donors* / ethics

Substances

  • Granulocyte Colony-Stimulating Factor