Healthy donors needed to boost Infection-Fighting cells for vulnerable patients
NCT ID NCT01553214
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 9 times
Summary
This study aims to improve the collection of granulocytes (a type of white blood cell) from healthy volunteers. Donors receive filgrastim and dexamethasone to move these cells into the bloodstream, then donate via apheresis. Up to 1,000 donors aged 18-75 can donate up to 12 times per year. The goal is to build a reliable donor registry to meet patient needs at the NIH Clinical Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- filgrastim and dexamethasone
- What this could lead to
- If successful, this could create a reliable donor program to provide granulocyte transfusions for patients with weakened immune systems, helping them fight infections.
- What could go wrong
- This is a Phase 4 study focused on donor feasibility, not treatment outcomes. Long-term effects of repeated filgrastim and dexamethasone in donors are still being monitored.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2012
- Expected to finish
-
Jan 2032
An estimate. End dates often move.
- Lead sponsor
-
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.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet the following restrictions: * Age greater than or equal to18 and less than or equal to 75 years * If hypertension is present, must be well-controlled on medications * If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications * If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The only exception to this is a history of bilateral cataract extractions due to PSC. EXCLUSION CRITERIA: * Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR. * Weight less than 50 kg (110 lbs). * History of coronary heart disease * Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100) * Diabetes mellitus requiring insulin * Active, symptomatic peptic ulcer disease * History of iritis or episcleritis * Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required. * Lithium therapy * Pregnancy or nursing (breast feeding) * Renal function eGFR \< 45 ml/min/1.73m(2)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Allogeneic granulocyte donation are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States