National Institutes of Health Clinical Center (CC)
Background: Many different research projects need a steady supply of human blood. Blood donated by screened, healthy people may be used to test new drugs, for example, or to learn how blood cells work. Scientists from the National Institutes of Health and the Food and Drug Administration want to collect blood from donors for use in laboratory studies. Objective: To collect blood and blood parts from healthy donors for research. Eligibility: Healthy people aged 18 years and older who weigh more than 110 pounds. They must meet the requirements to donate blood for research. Participants will be screened. A nurse will check their general health. The veins in both arms will be checked to make sure they are good for donation. Participants may donate whole blood as often as they wish, but no more than 2 cups will be taken over an 8-week period. At each visit, they will fill out a questionnaire about their health, and a small sample of blood will be tested to make sure it is safe to donate. Participants may also opt to donate only white blood cells. They will undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle. Those who donate white blood cells called granulocytes may need to take 2 drugs, including a steroid, the day before. Participants who repeat this donation will need an eye exam. Participants may remain in the study for 20 years.
Study Description: This protocol is designed to provide a mechanism for the Department of Transfusion Medicine (DTM), Clinical Center (CC) to collect and process blood components from paid, healthy volunteer donors for distribution to National Institutes of Health (NIH) intramural Investigators and Food and Drug Administration (FDA) researchers for in vitro laboratory use. Objectives: PRIMARY OBJECTIVE: To provide a mechanism that is reviewed and approved by the IRB, for the DTM CC to collect and process blood and blood components from paid, healthy, volunteer donors for distribution to NI…
* INCLUSION CRITERIA: Donors must meet the eligibility criteria for volunteer blood donation, defined in the Code of Federal Regulations 21 CFR 640 and AABB Standards as modified in the 2007 FDA/CBER Guidance Document: Eligibility Criteria for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products except for foreign travel history and other conditions outlined in exclusion criteria. * Ability of subject to understand, ask questions, and the willingness to provide written informed consent. * Age greater than or equal to 18 years. * Weight is greater than 110 pounds. * Donors w…