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.
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)
Single group
Filgrastim
DrugDonors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.
Dexamethasone
DrugDonors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.
Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program
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.
Long-term adverse effects of repeated doses of filgrastim and dexamethasone in volunteer apheresis donors
Changes in CBC or health histories over time in donors continuing in the program.
Frequency and severity (symptom grade) of acute adverse effects due to a single dose of filgrastim and dexamethasone in volunteer donors
Frequency and severity of acute adverse events related to G-CSF and dexamethasone in granulocyte donors.
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