Single-dose vs divided-dose G-CSF for healthy stem cell donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In healthy allogeneic stem cell donors, receiving G-CSF is standard to mobilize CD34+ cells, but the best dosing pattern (single vs divided daily doses) is not established. This Phase 3 trial compares two administration strategies to see which yields enough CD34+ cells and supports successful engraftment with acceptable safety. The study uses 5 days of G-CSF at 10 μg/kg/day and measures primary and secondary endpoints related to cell yield, engraftment timing, immune cell composition, and donor safety. It aims to provide high-quality evidence, including considerations for Asian donor populations. Conducted across multiple Zhejiang University-affiliated centers, it seeks to optimize donor experience and stem cell collection outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years.
2. Provision of written informed consent.
3. White blood cell (WBC) count \> 2.5 × 10⁹/L.
4. Absolute neutrophil count (ANC) \> 1.5 × 10⁹/L and platelet count \> 100 × 10⁹/L.
5. Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching.
6. Body weight ≥ 40 kg for females and ≥ 45 kg for males.

Exclusion Criteria:

1. Currently having any disease or condition that, in the judgment of the investigator, would make the donor unsuitable for participation in this study, such as severe neurological, hepatic, renal, endocrine, cardiovascular, hematologic, gastrointestinal, respiratory, or metabolic diseases; malignancies; myeloproliferative disorders; or psychiatric illnesses.
2. Currently having an active infection requiring systemic therapy.
3. Allergy to the study drug.
4. Presence of a malignant tumor.
5. Untreated HBV infection with HBV-DNA above the lower limit of detection.
6. HIV infection.
7. Addition of any new medication within 2 weeks prior to entry into this study.
8. Female donors who are pregnant or breastfeeding.

Where it's running

• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine.
  Hangzhou, Zhejiang, China Recruiting
• The Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Jinhua Central Hospital
  Jinhua, Zhejiang, China Recruiting
• The Affiliated People's Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yi Luo — First Affiliated Hospital of Zhejiang University
• Study coordinator: YIBO Wu
• Email: wuyibo7@126.com
• Phone: +8657187233801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.