Protocol Number: 00-CC-0165
Unlike bone marrow, the bloodstream contains few stem cells. Therefore, donors are given G-CSF (also called filgrastim)-a growth factor naturally produced by the body-before cell collection. G-CSF boosts bone marrow production of stem cells and mobilizes them to enter the bloodstream, allowing enough cells to be collected for transplantation. G-CSF-mobilized blood stem cells are often used for transplantation in recipients who are related to their donors. This study will evaluate a system for using this same method in unrelated donors and recipients. The Food and Drug Administration has approved G-CSF for several uses, including collection of blood stem cells from patients who are receiving transplants of their own stem cells; for patients with cancer who are receiving chemotherapy; patients who are getting bone marrow transplants; and patients with diseases that cause very low white blood cells counts. Individuals matched by the National Marrow Donor Program with a potential recipient for blood stem cell donation are eligible for this study. Participants will receive oral and written information about all the procedures involved in both bone marrow and peripheral blood stem cell collection, from donor evaluation and testing through post-donation followup. They will then have a medical examination, including blood tests and urinalysis, electrocardiogram and chest X-ray, to make sure that neither the donor nor the recipient will incur unexpected risks from the procedure. If the evaluation confirms that the donation can proceed, the donor will receive G-CSF injections under the skin once a day for 4 or 5 days. Blood samples (1/2 to 1 tablespoon each) will be collected on the first and fourth days of G-CSF injections to measure blood cell counts. Stem cells will then be collected by a procedure called apheresis. The donor lies in a recliner chair, and a needle is placed in a vein in each arm. Blood is collected from one arm and passes through a special machine called a blood cell separator. The machine collects the stem cells in a bag and directs the rest of the blood back through the needle in the other arm. One or two donations will be needed, depending on the size of the recipient and the number of stem cells circulating in the donor's bloodstream. Each donation takes about 4 to 5 hours. One-half tablespoon of blood is drawn before and after each donation to measure blood cell counts. Two days after donation and again one week after donation, donors will be questioned about any symptoms the may experience. Another blood sample (1/2 tablespoon) will be collected 1 month after cell donation and then yearly for an indefinite number of years to measure cell counts.
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Warren Grant Magnuson Clinical Center (CC) |
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