Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

Healthy volunteer donors

• 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 who have a family history of CJD, donors who have undergone tattooing or body piercing, donors who have received a graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis in the last 12 months, are similarly eligible for research-use only donations on this protocol.
• Donors who have traveled to Europe, Africa, Asia, and areas of South America, who are rendered ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations
• Donors with a history of repeat false positive HTLV I/II, who are rendered ineligible for allogeneic donation, are eligible for research donations.
• Donors with a positive antibody to hepatitis B core antigen (anti-HBc) only, without other positive infectious disease markers, are eligible for research donations.
• Donors with HLA antibodies are eligible for research donations.
• Donors who have received a xenotransplant are eligible for research donations.
• Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of >= 45mL/min/1.73m^2.

Investigators are informed that eligibility standards for research donors differ from those for transfusion donors through an electronic User Agreement which they electronically sign when they register to receive blood components on this protocol.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

• Pregnancy.
• Known heart, lung, kidney disease, or bleeding disorder.
• History of sickle cell disease.
• History of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. Deferral periods for high-risk activities (men who have sex with men (MSM), intravenous (IV) drug use or receipt of money or drugs in exchange for sex) will not exceed the corresponding deferral period as defined for allogeneic blood donors.
• History of malaria in the past 12 months.
• Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. HES and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression.
• Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease.