1. Leukapheresis

2. Granulocytes by Apheresis The National Institutes of Health (NIH) Clinical Center (CC) collects and transfuses about 100 granulocyte products each year to treat patients with life-threatening infections and severely impaired white blood cell function.

3. What Is a Granulocyte? A granulocyte is a type of white blood cell which fights bacteria and fungi. Patients with bone marrow failure syndromes, or those undergoing chemotherapy or marrow transplantation, often do not make enough of their own granulocytes (low numbers of these cells) to prevent serious infections.

4. Such patients may benefit from a course of granulocyte transfusions (Transfusions of these cells can help improve the body's ability to fight infection).

5. What Is Granulocytapheresis? Granulocytapheresis is the process by which granulocytes are collected from a healthy donor. Similar to plateletpheresis, blood is withdrawn from a vein and directed into a machine that contains a sterile disposable kit. Granulocytes are separated by a spinning process and concentrated in a plastic bag. The remaining parts of the blood are returned to the donor through a second needle.

6. Is Granulocytapheresis Safe? Yes. The machine and the procedure used for granulocyte collection are approved by the Food and Drug Administration, and all plastics and needles coming into contact with the donor are discarded after use.

7. Two medications are given to the donor the day before collection to boost the donor's granulocyte count. These medications are approved for donor use under an NIH protocol.

8. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim (G-CSF) (granulocyte colony-stimulating factor ) and dexamethasone (corticosteroids ), can help move the cells to the bloodstream to be collected by apheresis. stimulation of the donor typically increases the recipient's granulocyte count by 1,000 cells/uL, and the increase in counts is generally sustained for 24 to 48 hours.

9. Short term adverse effects of G-CSF and dexamethasone, including bone pain, myalgias, headache, insomnia and fatigue, are well known and possible long term effects, including cataracts from serial steroid administration, have been described. Researchers want to study the best ways to collect these white blood cells.

10. Who Is Eligible to Give Granulocytes? Granulocyte donors are healthy, unpaid volunteers between the age of 18 and 75 who meet the criteria for blood and platelet donors. Granulocyte donors must meet some additional criteria described in the protocol. Granulocyte donors should refrain from taking aspirin for 48 hours prior to donation.

11. 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.

12. 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. Participants will be eligible to donate until they reach their 76th birthday.

13. EXCLUSION CRITERIA: Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA. Weight less than 50 kg (110 lbs) History of coronary heart disease Uncontrolled hypertension (systolic BP > 160, diastolic BP > 100) History of hepatitis or injection drug use Diabetes mellitus requiring insulin Active, symptomatic peptic ulcer disease History of iritis or episcleritis Sickle cell disease Lithium therapy Pregnancy or nursing (breast feeding)

14. How Long Does Granulocytapheresis Take? Giving granulocytes with use of an apheresis machine takes about 2.5 hours, which is slightly longer than a plateletpheresis donation. The donor has enough time to enjoy a full-length movie.

15. Leukapheresis Leukapheresis is a laboratory procedure in which white blood cells are separated from a sample of blood.

16. Leukapheresis may be performed to decrease a very high white blood cell count. In the case of hematological malignancies such as acute leukomias, white blood cell counts may be high enough to cause "sludging" in the capillaries. This can affect retinal vasculature leading to vision changes, pulmonary vasculature leading to shortness of breath from decreased efficiency in oxygen exchange, as well as other organ systems such as the brain which would become clinically apparent with neurological deterioration of a patient.

17. Leukapheresis may also be performed to obtain the patient's own blood cells for later transplant. White blood cells may be removed to protect them from damage before high-dose chemotherapy, then transfused back into the patient, in the treatment of advanced breast cancer. Another novel use of cells obtained through leukapheresis is to stimulate a patient’s immune system to target prostate cancer cells. Also used as a treatment for autoimmune disease such as ulcerative colitis and rheumatoid arthritis, where these cells play an active part in the inflammation process.

18. is used for systemic infections in patients with neutropenia. The product generally has a 24 hour shelf life from collection

19. Ulcerative colitis Ulcerative colitis is a disease of the colon (large intestine), that includes characteristic ulcers, or open sores. Ulcerative colitis is treated as an autoimmune disease.

20. Rheumatoid arthritis Rheumatoid arthritis (RA) is an inflammatory disorder that may affect many tissues and organs, but principally attacks flexible (synovial) joints --- (which is the most common and most movable type of joints in the body of a mammal). The process produces an inflammatory response of the capsule around the joints.

21. Neutropenia is a granulocyte disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cells. Neutrophils usually make up 50-70% of circulating white blood cells and serve as the primary defense against infections by destroying bacteria in the blood. Hence, patients with neutropenia are more susceptible to bacterial infections and, without prompt medical attention, the condition may become life-threatening. Blood film with a striking absence of neutrophils, leaving only red blood cells and platelets