Clinical Research Directory

CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors

Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies. This prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF once daily for 4-5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures. The study protocol was substantially amended following approval by the Institutional Review Board. The amendments included revisions to the G-CSF administration regimen, the primary and secondary outcome measures, and the assessment schedule. Enrollment under the revised protocol commenced on 1st Nov. Participants enrolled under the previous protocol version will be documented separately and will not be included in the prespecified primary analysis of the revised-protocol cohort.