Chronotherapy of G-CSF for stem cell mobilization in healthy donors
Official title: Effect of Different Administration Timing of G-CSF on Peripheral Blood CD34+ Cell Mobilization in Healthy Donors: A Prospective Multicenter Randomized Controlled Trial
Run by First Affiliated Hospital of Zhejiang University · NCT07423728 · Data updated 2026-11-12
This trial tests whether giving G-CSF in the morning versus the evening improves the number of CD34+ cells in healthy donors benefiting allogeneic stem cell transplantation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07423728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 who are eligible and medically cleared to donate stem cells and have stable circadian rhythm.
✕Probably not a fit
Donors with atypical circadian biology or other factors affecting mobilization may not experience an advantage from time-of-day dosing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized trial compares two daily dosing times for G-CSF (08:00 vs 20:00) given for 4–5 days in healthy adult donors. The goal is to see if circadian timing affects circulating CD34+ cell levels and overall collection efficiency for allo-HSCT. Donor age and sex are used to balance groups, and the first apheresis follows after the fourth dose. The study is open-label because dosing time cannot be blinded, while the statistician remains blinded until database lock. Results may identify a simple, practical dosing schedule to streamline donor collection procedures.
Why it matters
Potential benefit: If successful, donors may reach higher CD34+ cell levels with the chosen dosing time, potentially making stem cell collection more efficient for recipients.
How similar studies have gone: Prior work suggests circadian timing can influence hematopoietic cell trafficking, but direct randomized data in G-CSF mobilization are limited, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-55 years 2. HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria 3. Body weight ≥35 kg and adequate blood volume/BSA for apheresis 4. Karnofsky score ≥80 5. Screening labs meet thresholds (Hb/platelets/ANC, liver/renal/coagulation), no splenomegaly, pregnancy test negative if applicable 6. Written informed consent 7. Stable circadian rhythm before mobilization (no night shift/no ≥3 time-zone travel; avoid melatonin/sedatives or other agents affecting sleep/circadian rhythm) Exclusion Criteria: 1. Prior/current hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease) 2. Significant cardiovascular/structural heart disease, uncontrolled hypertension, uncontrolled diabetes 3. Neurologic/psychiatric disorders affecting adherence 4. Sleep/circadian disorders; recent night shift or ≥3 time-zone travel 5. Prohibited medications (e.g., beta-blockers, systemic steroids \>10 mg prednisone-equivalent ≥7 days, melatonin/psychotropics; recent G-CSF/GM-CSF/CXCR4 inhibitor use) 6. Severe allergy to G-CSF or components
Where it's running
-
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Recruiting -
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Hengwei Wu, MD
- Email: cctv3194495@163.com
- Phone: +8619858162455
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.