Blood DonorsNCT07877259
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
An observational study of Blood Donors and Apheresis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Donors, Apheresis
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 7 Aug 2046
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteer donors
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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 NIH intramural investigators and FDA laboratories, and/or shared with their outside collaborators under sanctioned agreements, for in vitro research use.
SECONDARY OBJECTIVE:
To monitor biological parameters such as cell counts and biochemical changes in blood donors over the course of repeated donations.
- Conditions
- Blood Donors, Apheresis
- Keywords
- Volunteer Donor, Research Samples, Leukapheresis, Plateletpheresis, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| research donors | healthy volunteers (age 18+) who donate blood for in vitro research purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of samples to researchers
Provision of samples to researchers
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start11 Nov 2026 (estimated)
- Primary completion7 Aug 2046 (estimated)
- Study completion7 Aug 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leonard N Chen, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877259
- Sponsor's protocol ID
- 10002749
- Other IDs
- 002749-CC
- Status last verified
- 30 Sep 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
- ClinicalTrials.gov ID
- NCT07877259
- Acronym / sponsor ID
- 10002749
- Conditions
- Blood Donors, Apheresis
- Keywords
- Volunteer Donor, Research Samples, Leukapheresis, Plateletpheresis, Natural History
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 7 Aug 2046 (estimated)
- Study completion
- 7 Aug 2046 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 NIH intramural investigators and FDA laboratories, and/or shared with their outside collaborators under sanctioned agreements, for in vitro research use.
SECONDARY OBJECTIVE:
To monitor biological parameters such as cell counts and biochemical changes in blood donors over the course of repeated donations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research donors | – | –healthy volunteers (age 18+) who donate blood for in vitro research purposes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteer donors
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Provision of samples to researchers
Time frame: weekly
Provision of samples to researchers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonard N Chen, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donors and Apheresis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonard N Chen, M.D. ((301) 435-7969, leonard.chen@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provision of samples to researchers (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.