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New treatment option for Healthy Hematopoietic Stem Cell Donor
Official title Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
ClinicalTrials.gov ID: NCT07692841
What this study is testing
What is Single-dose Granulocyte colony-stimulating factor (G-CSF)?
Single-dose Granulocyte colony-stimulating factor (G-CSF) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for healthy hematopoietic stem cell donor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- National and international guidelines/consensus recommend G-CSF (granulocyte colony-stimulating factor) at 10 μg/kg/day as a single daily dose or divided into two daily doses for mobilization in healthy donors for allogeneic hematopoietic stem cell transplantation. However, there is no consensus or standard regarding single versus divided dosing, and high-quality evidence is lacking.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years.
- Provision of written informed consent.
- White blood cell (WBC) count \> 2.5 × 10⁹/L.
- Absolute neutrophil count (ANC) \> 1.5 × 10⁹/L and platelet count \> 100 × 10⁹/L.
- Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching.
You likely can't join if
- Currently having any disease or condition that, in the judgment of the investigator, would make the donor unsuitable for participation in this study...
- Currently having an active infection requiring systemic therapy.
- Allergy to the study drug.
- Presence of a malignant tumor.
- Untreated HBV infection with HBV-DNA above the lower limit of detection.
- HIV infection.
See the full eligibility criteria
- Age 18-65 years.
- Provision of written informed consent.
- White blood cell (WBC) count \> 2.5 × 10⁹/L.
- Absolute neutrophil count (ANC) \> 1.5 × 10⁹/L and platelet count \> 100 × 10⁹/L.
- Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching.
- Body weight ≥ 40 kg for females and ≥ 45 kg for males.
- 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...
- Currently having an active infection requiring systemic therapy.
- Allergy to the study drug.
- Presence of a malignant tumor.
- Untreated HBV infection with HBV-DNA above the lower limit of detection.
- HIV infection.
- Addition of any new medication within 2 weeks prior to entry into this study.
- Female donors who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
- Jinhua, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Hangzhou, Zhejiang, China; Jinhua, Zhejiang, China; Ningbo, Zhejiang, China; Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.