What will happen during the study?

The subject will be asked to take a drug called G-CSF (granulocyte colony stimulating factor) for 3-6 days prior to the procedure to collect cells. G-CSF is a natural human protein that causes the production of granulocytes (infection fighting white blood cells) in the bone marrow. The G-CSF is given subcutaneously (injection under the skin) daily for 3-6 days prior to the collection of the cells. The G-CSF will either be given at the clinic or at home.

If the subject receives G-CSF in the clinic, the subject will need to come to Riley every day during this period. 

If the subject will take the G-CSF at home, the subject will give the injections to themselves. The study staff will teach subjects how to do this and give them more information on how the G-CSF should be stored.  This helps the cells move from the bone marrow to the blood. The subject will need to come to Riley for an outpatient visit prior to the start of the study to complete a blood count (CBC) that will be drawn to check the number of white blood cells (to fight infection), red blood cells (help carry oxygen through the body) and platelets (help blood to clot) before getting G-CSF and before and after the procedure to collect the cells. Blood test(s) may require up to 30 ml (approximately 2 tablespoons) of blood. Also at this visit prior to the start of study all females will be required to have a urine pregnancy test. The nature of the procedure to collect the cells is called leukapheresis (or "apheresis"). Blood is removed through a needle inserted into the vein in one arm where it will pass through tubing attached to the cell separating machine where the blood is separated. Centrifugation is the actual "spinning down" or separation of the various parts of the blood. Mostly white blood cells, some platelets, a small amount of red blood cells and some plasma (the liquid component of the blood) will be collected. The centrifuge instrument will remove some of the white cells and platelets (cells used to form clots) and some plasma (the liquid component of the blood). The total amount of cells and plasma removed will be approximately 200-250 ml or approximately 6-8 fluid ounces. The remainder of the blood will be returned through another needle inserted into the vein of the other arm. The procedure as described will require three to four hours and will be done as an out-patient visit in the Riley Apheresis Center.