Improving White Blood Cell Collection From Healthy Donors

This study aims to improve how white blood cells called granulocytes are collected from healthy volunteers. These cells help fight infections, especially in people who have had chemotherapy or bone marrow transplants. Researchers are giving healthy donors two medications, filgrastim and dexamethasone, before they donate. These medications help move granulocytes from the bone marrow into the bloodstream, making them easier to collect. The study wants to see if this method is practical and effective for a volunteer donation program. You may be able to join if you are between 18 and 75 years old and meet standard blood donor requirements.

Study design: This is an interventional study with a planned enrollment of 1000 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary goal of the study will be measured annually.

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Improving White Blood Cell Collection From Healthy Donors

Recruiting

PHASE4Ages 18–75Interventional

National Institutes of Health Clinical Center (CC)

~1,000 participants

Updated 2026-09-01 on ClinicalTrials.gov

What's tested:FilgrastimDexamethasone

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program

Measured over Annually

Conditions

Allogeneic Granulocyte Donation

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Leonard N Chen, M.D. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)

Who to contact

Tania M Scinto

[email protected]

(301) 496-9702

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

Operational feasibility and impact of managing a volunteer community donor granulocytapheresis programAnnually
Establishment of a donor registry sufficient to meet the granulocyte transfusion needs of all Clinical Center patients. This endpoint shall include(1) the number of donors recruited into the program (2) the retention rate of donors in the program, assessed by number of donations per year per donor, cumulative number of granulocyte donations per donor, and duration of participation in the program per donor (3) the number of requests for a course of granulocytes per year and the number and percent of these requests that could be met, including the percent of all requested transfusion days on which granulocytes were available (4) the impediments to meeting all requests for granulocyte components, with an analysis of whether these are due to lack of an adequate donor supply or lack of adequate staffing or apheresis capacity (5) characteristics of the patients who are supported by a course of granulocyte transfusions.

Trialytics