The Safety of Granulocyte Colony Stimulating Factor (G-CSF) Administration in Pediatric Donors before Peripheral Hematopoietic Stem Cell Donation

Introduction:Although administration of G-CSF to healthy donors for mobilization and collection of peripheral blood stem cell (PBSC) is common in adult volunteers, there are limited data on short-and especially long-term efficacy in healthy pediatric donors, notably due to ethical issues. The purpose of this study was to assess the short- and long-term adverse effects of using G-CSF in pediatric sibling donors.

 

Methods: Healthy pediatric sibling (age≤15 years) donors of PBSC whose parents were reluctant to donate stem cells from bone marrow (BMSC) were enrolled in this prospective study. Written informed consent was obtained from all the children's parents before entering the transplantation program. G-CSF (Neupogen®, Roche, Switzerland) was administered at 5µg/kg once daily for 3 consecutive days and twice on the fourth day. Questionnaires were used to assess the health status of donors.

 

Results:104 healthy pediatric donors of PBSCs aged 2.5-15 years (median age: 10 years) were followed for a median of 1527 days (393-4621 days). The most common short-term side effects were headache (n=4) and fatigue (n=2). None of the mentioned medical problems worsened after G-CSF injection. Two pregnancies after the administration of G-CSF resulted in normal births. No malignancy or death was reported.

 

Discussion: To best of our knowledge, this is the first investigation on a large number of healthy pediatric donors to assess long-term effects of PBSC donation. Our study indicates PBSC collection, using G-CSF could be a safe and effective method for healthy pediatric donors whose parents are reluctant to allow their child to undergo collection of bone marrow because of concerns over side effects of anesthesia. Further studies with larger sample size are required to determine the safety of using G-CSF in healthy children.