Healthy volunteers key to safer stem cell transplants
NCT ID NCT00001529
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 6 times
Summary
This study collects blood stem cells from healthy volunteers after they receive a growth factor injection. Researchers aim to develop better methods to remove the white blood cells that cause graft-versus-host disease, a serious complication of bone marrow transplants. Up to 500 volunteers aged 18-60 will participate to help improve transplant safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- filgrastim (G-CSF)
- What this could lead to
- If successful, this could lead to safer stem cell transplants with less risk of graft-versus-host disease.
- What could go wrong
- This is an early-stage lab study, not a treatment trial. Results may not translate to better patient outcomes.
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.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 1996
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy Volunteers
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Healthy individual aged 18 to 60 years. * No active infection or history of recurrent infection. * Normal renal function: creatinine \<1.5 mg/dL or estimated glomerular filtration rate (eGFR) \>=60 mL/min/1.73 m\^2, with no significant proteinuria. Normal liver function: bilirubin \<2.0 mg/dL (when unconjugated), transaminases \<2.0x ULN in the absence of known liver disease. Normal blood count: WBC 2,500-11,000/microliter, ANC \>1,500/microliter, platelets \>150,000/microliter, hemoglobin \>12.0 g/dL. * Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke. * Healthy female subjects of childbearing age should have a negative serum pregnancy test with one week of beginning G-CSF administration. * Female subjects should not be lactating. * Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test. * Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol. * Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry. EXCLUSION CRITERIA: * Active viral, bacterial, fungal or parasite infection. * Female with positive pregnancy test or lactating. * Active or moderate-to-severe autoimmune disease that is currently treated or expected to require immunosuppressive therapy. Candidates with stable, well-controlled mild autoimmune disease may be considered on a case-by-case basis. * Active or recent malignancy within the past 5 years. Individuals with remote (\>5 years) histories of low-risk malignancies in remission (e.g., localized prostate cancer) or treated basal cell carcinoma may be included. * History of any hematologic disorders. * History of clinically significant cardiovascular disease (e.g., symptomatic coronary artery disease, uncontrolled hypertension). Minor risk factors must be evaluated on a case-by-case basis (e.g., controlled hypertension). * Any positive serum screening test as listed in eligibility. * Allergy to G-CSF or bacterial E coli products. * Administration of NSAID within. 5-7 days of starting the protocol, depending on drug half-life. * History of G-CSF administration and leukapheresis within past 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug stop the Body's attack after stem cell transplants?
- Can a cancer drug tame graft-versus-host disease when steroids fail?
- New antibody may offer safer shield against transplant complications
- New drug combo aims to tame immune attack after stem cell transplants
- New drug cocktail aims to stop transplant rejection in blood cancer patients