G-CSF for Granulocyte Donation
This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before.
People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called dexamethasone and a growth factor called G-CSF the day before donation. These drugs stimulate white cell production, allowing many more cells to be collected than would otherwise be possible. A single dose of G-CSF given to healthy people increases their white cells counts by four to five times the next day.
It would be preferable, however, to give G-CSF the same day of donation, if possible. Therefore, this study will measure white cell counts in healthy people at various intervals after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare the following: granulocyte counts at seven different intervals after injection of the drug or drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of giving G-CSF alone or with dexamethasone.
Each participant will undergo four procedures, each four weeks apart as follows: donate a small blood sample; receive an injection of G-CSF under the skin or into a vein; and take either two dexamethasone tablets or two placebo tablets.
Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given. Participants will answer questions about how they feel before the drugs are given and at the various intervals after taking the drugs.
The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advantageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donor's pre-collection granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 microgram/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 micrograms/kg given intravenously, G-CSF 5 micrograms/kg subcutaneously, G-CSF 5 micrograms/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 micrograms/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1/2, 1, 2, 4, 6, 8 and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF.
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Granulocyte colony-stimulating factor, Dexamethasone
Warren G. Magnuson Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00001842
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Glycoproteins found in a subfraction of normal mammalian plasma and urine. They stimulate the proliferation of bone marrow cells in agar cultures and the formation of colonies of granulocytes and/or macrophages. The factors include INTERLEUKIN-3; (IL-3); GRANULOCYTE COLONY-STIMULATING FACTOR; (G-CSF); MACROPHAGE COLONY-STIMULATING FACTOR; (M-CSF); and GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; (GM-CSF).
Receptors that bind and internalize GRANULOCYTE COLONY-STIMULATING FACTOR. Their MW is believed to be 150 kD. These receptors are found mainly on a subset of myelomonocytic cells.
Granulocyte colony stimulating factors prepared by recombinant DNA technology.
A glycoprotein of MW 25 kDa containing internal disulfide bonds. It induces the survival, proliferation, and differentiation of neutrophilic granulocyte precursor cells and functionally activates mature blood neutrophils. Among the family of colony-stimulating factors, G-CSF is the most potent inducer of terminal differentiation to granulocytes and macrophages of leukemic myeloid cell lines.
Receptors that bind and internalize the granulocyte-macrophage stimulating factor. Their MW is believed to be 84 kD. The most mature myelomonocytic cells, specifically human neutrophils, macrophages, and eosinophils, express the highest number of affinity receptors for this growth factor.
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