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

被引:84
作者
Pulsipher, MA
Nagler, A
Iannone, R
Nelson, RM
机构
[1] Univ Utah, Primary Childrens Med Ctr, Pediat Blood & Marrow Transplant Program, Salt Lake City, UT 84113 USA
[2] Chaim Sheba Med Ctr, IL-52621 Tel Hashomer, Israel
[3] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA
[4] Univ Penn, Philadelphia, PA 19104 USA
关键词
ethics of bone marrow donation; granulocyte colony stimulation factor; pediatric bone marrow transplantation; pediatric donor safety;
D O I
10.1002/pbc.20708
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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: GCSF 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.
引用
收藏
页码:422 / 433
页数:12
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