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 - Report - MDSpire

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

  • By

  • 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

  • June 24, 2026

  • 0 min

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Clinical Report: Comparative Analysis of Single-Dose Pegylated G-CSF

Overview

This multicenter, randomized controlled study compares the efficacy and safety of single-dose pegylated G-CSF (Peg-G-CSF) versus daily G-CSF for mobilizing peripheral blood stem cells (PBSC) in healthy donors. Results indicate that Peg-G-CSF is as effective as daily G-CSF in achieving optimal CD34+ cell yields with similar side effect profiles.

Background

The mobilization of PBSC is crucial for allogeneic hematopoietic stem cell transplantation, traditionally requiring daily G-CSF injections, which can be inconvenient for donors. Peg-G-CSF, with its longer half-life, offers a potential alternative that may enhance donor experience while maintaining efficacy. Understanding the comparative effectiveness of these agents is essential for optimizing donor mobilization strategies.

Data Highlights

GroupDonors with ≥4×106 CD34+ cells/kg
Peg-G-CSF80 (83.3%)
G-CSF76 (79.2%)

Key Findings

  • 83.3% of donors in the Peg-G-CSF group collected ≥4×106 CD34+ cells/kg recipient weight.
  • 79.2% of donors in the G-CSF group achieved the same target.
  • The median yield of CD34+ cells was comparable between Peg-G-CSF and G-CSF groups.
  • No significant differences in side effects, engraftment, GVHD, or survival were observed between the two groups.
  • CD34+ cell count on day 5 significantly affected the yield of CD34+ cells.

Clinical Implications

The findings suggest that Peg-G-CSF can be a viable alternative to daily G-CSF for PBSC mobilization, potentially improving donor convenience without compromising efficacy or safety. Clinicians may consider Peg-G-CSF for mobilization strategies in healthy donors.

Conclusion

Single-dose Peg-G-CSF demonstrates comparable efficacy and safety to traditional daily G-CSF for PBSC mobilization.

Related Resources & Content

  1. Bone Marrow Transplantation, 2020 -- Utilization of the G-CSF Biosimilar XM02 for Peripheral Blood Stem Cell Mobilization in Healthy Donors for Allogeneic Transplantation
  2. Bone Marrow Transplantation, 2024 -- Evaluating the Efficacy of Stem Cell Mobilization with Chemotherapy and G-CSF Compared to G-CSF Alone in Patients with Myeloma: A Randomized Phase II Open-Label Non-Inferiority Study
  3. Bone Marrow Transplantation, 2013 -- Effectiveness of Delayed Granulocyte Colony-Stimulating Factor Administration in Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
  4. Bone Marrow Transplantation, 2020 -- Plerixafor as a Salvage Therapy for Inefficient Mobilization in Allogeneic Stem Cell Donors: Findings from a Phase II Prospective Trial
  5. Mobilization and Collection of HSC - The EBMT Handbook - NCBI Bookshelf
  6. Filgrastim administration process | NMDP
  7. World Marrow Donor Association Statement on the Use of Plerixafor in Healthy Donors - Transplantation and Cellular Therapy
  8. Usefulness of pegfilgrastim for allogeneic peripheral blood stem cell collection from healthy donors - Shimizu - Transfusion
  9. Efficacy and Safety of Single-dose Pegfilgrastim for CD34 + Cell Mobilization in Healthy Volunteers: A Phase 2 Study - PubMed
  10. Stem-cell mobilization of healthy sibling donors with pegfilgrastim-A prospective open-label phase II trial - PubMed
  11. EBMT Handbook
  12. NMDP Filgrastim Administration Process
  13. World Marrow Donor Association Statement
  14. Usefulness of pegfilgrastim for allogeneic peripheral blood stem cell collection from healthy donors - Shimizu - Transfusion - Wiley Online Library
  15. Efficacy and Safety of Single-dose Pegfilgrastim for CD34 + Cell Mobilization in Healthy Volunteers: A Phase 2 Study - PubMed
  16. Stem-cell mobilization of healthy sibling donors with pegfilgrastim-A prospective open-label phase II trial (EudraCT no: 2005-004971-39) - PubMed
  17. Twice or once a day? Filgrastim dosing schedule for peripheral hematopoietic stem cells mobilization - ScienceDirect
  18. Healthy volunteer stem cell donors followed up 10 years after stimulation with biosimilar filgrastim - PMC
  19. Long-term outcomes of peripheral blood stem cell unrelated donors mobilized with filgrastim - PMC

Original Source(s)

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

  • by 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

  • June 24, 2026

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