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Protocol Details

Collection of Granulocytes by Apheresis of Healthy Donors Stimulated with Filgrastim (G-CSF) and Dexamethasone

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 75 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women



Recruitment Keyword(s)

Healthy Volunteer;


Allogeneic Granulocyte Donation

Investigational Drug(s)


Investigational Device(s)



Drug: Filgrastim
Drug: Dexamethasone

Supporting Site

NIH Clinical Center


- 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.


- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation.


- Healthy volunteers between 18 and 75 years of age.


- 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.

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- 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.


- 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)

- History of hepatitis or injection drug use

- 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)

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Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, Gersten ID, Mendizabal AM, Leather HL, Confer DL, Maziarz RT, Stadtmauer EA, Bola(SqrRoot) os-Meade J, Brown J, Dipersio JF, Boeckh M, Marr KA; Blood and Marrow Transplant Clinical Trials Network. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood. 2010 Dec 9;116(24):5111-6.

Baddley JW, Andes DR, Marr KA, Kontoyiannis DP, Alexander BD, Kauffman CA, Oster RA, Anaissie EJ, Walsh TJ, Schuster MG, Wingard JR, Patterson TF, Ito JI, Williams OD, Chiller T, Pappas PG. Factors associated with mortality in transplant patients with invasive aspergillosis. Clin Infect Dis. 2010 Jun 15;50(12):1559-67.

Stroncek DF, Yau YY, Oblitas J, Leitman SF. Administration of G--CSF plus dexamethasone produces greater granulocyte concentrate yields while causing no more donor toxicity than G--CSF alone. Transfusion. 2001 Aug;41(8):1037-44.

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Principal Investigator

Referral Contact

For more information:

Kamille A. West-Mitchell, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
(301) 594-5357

Tania Scinto
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C713
10 Center Drive
Bethesda, Maryland 20892
(301) 496-9702

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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