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Improving White Blood Cell Collection From Healthy Donors

NCT01553214 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-04-08

No results posted yet for this study

Summary

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

  • Allogeneic Granulocyte Donation

Interventions

DRUG

Filgrastim

Donors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.

DRUG

Dexamethasone

Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2032-01-01
Completion
2032-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01553214 on ClinicalTrials.gov