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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

5000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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.

Study population

Healthy volunteer donors

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institutes of Health Clinical Center (CC)

Study start

Nov 15, 2026 Estimated

Primary completion

Aug 7, 2046 Estimated

Study completion

Aug 7, 2046 Estimated

First posted

Oct 16, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts