Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone
National Institutes of Health Clinical Center (CC)
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.
Description
Bacterial and fungal infections in neutropenic patients or in patients with inherited disorders of neutrophil function continue to cause substantial morbidity and mortality. In particular, fungal infections are an increasingly important cause of death in patients receiving aggressive chemotherapy, in patients undergoing hematopoietic stem cell transplantation (HSCT), in patients with chronic granulomatous disease, and in patients with bone marrow failure syndromes such as severe aplastic anemia. The strongest predictor of progression and death from invasive mold infection in the cancer/ HSCT s…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: * 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…
Interventions
- DrugFilgrastim
Donors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.
- DrugDexamethasone
Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland