Efficacy and safety of the single-dose pegylated G-CSF vs. daily G-CSF for peripheral blood stem cells mobilization in donors: a multicenter, randomized controlled trial.

Authors

Jiali Li, Sha Zhou, Xiaoping Li, Xiangyu Ma, Sanbin Wang, Yicheng Zhang, Shifeng Lou, Jun Rao, Ping Wang, Lidan Zhu, Ting Chen, Xixi Xiang, Shichun Gao, Han Yao, Peiyan Kong, Lei Gao, Cheng Zhang, Xi Zhang, Li Gao

Published in

Frontiers in immunology. Volume 17. Pages 1737252. Epub Jun 24, 2026.

Abstract

The mobilization of peripheral blood stem cells(PBSC) needs daily injection of granulocyte colony stimulating factor (G-CSF), which brings inconvenience to healthy donors. Can pegylated granulocyte colony-stimulating factor (Peg-G-CSF) solve this problem by single dose injection?
This multicenter, randomized controlled study was conducted from May 2018 to April 2019. Eligible donors were randomly selected to received treatment with 12 mg Peg-G-CSF on day 1 or 10 µg/kg/d G-CSF consecutively from day 1. PBSC apheresis of the donors was conducted on day 5. The primary endpoint was the percentage of donors who collected ≥4×10⁶ CD34⁺cells/kg recipient weight after single apheresis.
Eighty (83.3%) of 96 donors in the Peg-G-SCF group and 76 (79.2%) of 96 donors in the G-CSF group collected ≥4×10⁶ CD34⁺cells/kg recipient weight. The peak value of circulating CD34⁺ cell count occurred on day 5 in both groups. The median yield of CD34⁺ cell collected in the Peg-G-CSF group was comparable to that in the G-CSF group by a single apheresis procedure. Moreover, the incidence of side effects in both groups was similarly, no significant difference was observed in engraftment, graft-versus-host disease (GVHD) or survival between the two groups of recipients. By multivariate analysis, The CD34⁺ cell count on the fifth day was the variable that may have significantly affected the CD34⁺ yield.
Mobilization via a single injection of Peg-G-CSF can match traditional G-CSF mobilization in terms of efficacy and safety and is expected to provide a better alternative to traditional G-CSF mobilization.
www.chictr.org.cn, identifier ChiCTR1800015716.

PMID:
42421945
Bibliographic data and abstract were imported from PubMed on 09 Jul 2026.

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