INCLUSION CRITERIA
Ability to give informed consent to participate in the protocol.
Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (including minimum HCT of 28%, platelet count greater than 50,000/uL). Negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1.
Listed below are acceptable medical conditions for inclusion in this protocol. They are derived from donor criteria that pertain to stem cell mobilization and peripheral blood leukapheresis described by the National Marrow Donor Program. Medical conditions that limit bone marrow harvest or re-infusion of cells into stem cell recipients do not apply to this protocol.
Age: Volunteers of adult age including those over 60 years old who have no significant cardiovascular disease will be allowed to enroll.
Allergies: If volunteers suffer from common allergies to animals, the environment, or medications other than G-CSF, they will be allowed to enroll.
Arthritis: In general, if volunteers have mild to moderate osteoarthritis or degenerative arthritis, they will be allowed to enroll.
Cancer: If volunteers have a history of cancer or currently have cancer that does not affect their cardiovascular status, they will be allowed to enroll.
Mental health conditions: If volunteers have mental health conditions that are well-controlled, they will be allowed to enroll.
Diabetes: If volunteers have diabetes, a careful evaluation of their current health status will be necessary. In general, if their diabetes is well-controlled by either diet or oral medications, and have no significant cardiovascular disease, they will be allowed to enroll.
EXCLUSION CRITERIA
Any concomitant condition or illness that will result in an inability to undergo G-CSF mobilization or apheresis listed below.
Allergy to G-CSF or bacterial E. coli products.
Autoimmune diseases, such as immune thrombocytopenic purpura, rheumatoid arthritis or systemic lupus erythematosus.
Patients with active pulmonary disease.
Significant cardiovascular disease or related symptoms such as chest pain, shortness of breath, or uncontrolled hypertension. If volunteers have heart conditions such as well-controlled arrhythmias, or mitral valve prolapse that does not require medication or restrictions, they will be allowed to enroll. If volunteers have elevated blood pressure that is well-controlled by medication or diet and if there is no associated heart disease, they will be allowed to enroll.
Epilepsy: If volunteers have had more than one seizure in the past year, they will not be allowed to enroll. If volunteers have well-controlled epilepsy and have had no seizures in the past year, they will be allowed to enroll.
Active infections.
Pregnant and lactating women.
Splenomegaly: Patients having splenic diameters greater than 13.0 cm at the time of initial assessment will be excluded from the protocol.
Sickle cell disease.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/31/2009