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Stem cell donation: one shot or two? trial seeks best way to mobilize cells

NCT ID NCT07692841

Disease control Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This trial tests whether giving the drug G-CSF as one daily injection or two smaller injections works better for collecting stem cells from healthy donors. The goal is to find the safest and most effective dosing schedule for donors of all ages. The study involves 560 healthy volunteers who will receive either a single or divided daily dose for up to 7 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Granulocyte colony-stimulating factor (G-CSF)
What this could lead to
If one dosing schedule proves better, it could make stem cell donation more efficient and comfortable for healthy donors, improving transplant success.
What could go wrong
This is a single trial focused on Asian donors, so results may not apply to all populations. G-CSF can cause bone pain and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy allogeneic hematopoietic stem cell donor Healthy hematopoietic stem cell donor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jinhua Central Hospital

    RECRUITING

    Jinhua, Zhejiang, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Affiliated People's Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine.

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China