The use of granulocyte–colony‐stimulating factor in volunteer unrelated hemopoietic stem cell donors

Abstract

Granulocyte-colony-stimulating factor (G-CSF) is used for the mobilization of hemopoietic stem cells in healthy donors. It has a number of common side effects such as bone pain, which resolve rapidly after administration is discontinued. Recent publications have raised concern that it might act as a trigger for the development of hematologic malignancy in susceptible individuals, possibly by causing genomic instability, but to date there is no evidence that healthy volunteer donors who receive G-CSF are at any increased risk. Ongoing studies aim to confirm whether or not G-CSF can cause chromosomal abnormalities in healthy donors. In the UK, the British Bone Marrow Registry and Anthony Nolan Trust give G-CSF to donors who have agreed to donate peripheral blood stem cells. It is recommended by the UK Registries at present that all stem cell donors are given updated information explaining the current uncertainties with regard to the use of G-CSF before they give informed consent to its administration. This information is based on a statement agreed by the World Marrow Donor Association for use by individual donor registries. Further, it is our current practice that all donors who have received G-CSF, as well as marrow donors who do not, should be under regular review for at least 10 years to allow the occurrence of any long-term adverse events to be documented.

Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors

“…Thus more data regarding short-and long-term sequels of rhG-CSF administration and leukapheresis have become available. [11][12][13] This study has been the largest prospective series of healthy unrelated donors supervised and followed up by a single apheresis center. The schedules for rhG-CSF administration and leukapheresis were the same in the majority (97.3%) of the donors.…”

Regeneration, health status and quality of life after rhG-CSF-stimulated stem cell collection in healthy donors: a cross-sectional study

“…12 Until now, there is no convincing evidence that rhG-CSF administration leads to an increased risk to develop hematological malignancies in healthy individuals. 13 The aim of our study was (1) to assess the short-term side effects of rhG-CSF administration and PBPC collection in our sibling donor population by monitoring of medical events and recording laboratory data on days 1, 7, 30 and 100; (2) to evaluate the influence of rhG-CSF and PBPC donation on health status and quality of life (QoL) assessed by a questionnaire in a cross-sectional study and (3) to investigate the long-term safety profile of rhG-CSF by evaluation of retrospective questions on intercurrent events, such as infections, occurrence of new diseases and need for new medications.…”

Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association

“…The WMDA and several experts in the field produced guidance at that time to indicate that there was insufficient evidence for an increased risk of malignancy in normal donors given G-CSF, and it was not, therefore, recommended to halt the donation of GCSF-mobilized PBSC from UD. [7][8][9][10] Two registry based laboratory studies are currently being performed to investigate these claims further. Thus far the studies have shown no increase in chromosomal abnormalities in PBSC donors compared to bone marrow donors or non-donor healthy controls (D Confer and E Nacheva, personal communications, 2011).…”