Actively Recruiting
Improving White Blood Cell Collection From Healthy Donors
Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-04-08
1000
Participants Needed
1
Research Sites
991 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors. Objectives: \- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation. Eligibility: \- Healthy volunteers between 18 and 75 years of age. Design: * Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility. * Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time. * Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation. * White blood cells will be collected through apheresis. The apheresis will last about 2 hours. * Participants will be eligible to donate until they reach their 76th birthday.
CONDITIONS
Official Title
Improving White Blood Cell Collection From Healthy Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet all standard eligibility criteria for allogeneic blood donors according to AABB and FDA regulations
- Age between 18 and 75 years
- If you have hypertension, it must be well-controlled with medication
- If you have a history of peptic ulcer disease, symptoms must be well-controlled with medication
- If you have cataracts, records from your eye doctor must be provided; if you have posterior subcapsular cataracts (PSC), you may receive filgrastim but not dexamethasone unless you had surgery for PSC in both eyes
You will not qualify if you...
- Do not meet standard allogeneic blood donor eligibility criteria per AABB and FDA regulations
- Weigh less than 50 kg (110 lbs)
- Have a history of coronary heart disease
- Have uncontrolled high blood pressure (systolic over 160 or diastolic over 100)
- Have diabetes requiring insulin
- Have active, symptomatic peptic ulcer disease
- Have a history of iritis or episcleritis
- Have sickle cell disease (trait is allowed)
- Are currently taking lithium therapy
- Are pregnant or breastfeeding
- Have kidney function with estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tania M Scinto
CONTACT
L
Leonard N Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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