Healthy donors needed to supply white blood cells for science
NCT ID NCT00104325
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 14 times
Summary
This study collects white blood cells from healthy volunteers using a procedure called cytapheresis. The cells are used for lab research, not to treat any disease. Participants must be 18 or older and can donate every 56 days.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2003
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of healthy males and females 18 years and older. Study subjects are anticipated to be non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be 10,000. This will allow us to try and maintain 200 active participants in this protocol. Volunteers are screened initially and annually by a health history questionnaire and laboratory testing to screen for bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Normal healthy males and females, age 18 years and older * Adequate venous access in bilateral upper extremities to accommodate at least a #18 gauge dialysis needle. * Willingness and ability to come to the NIA Apheresis Unit at Harbor Hospital in Baltimore for a blood collection procedure approximately every 56 days. EXCLUSION CRITERIA: * Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required. * Unable to provide informed consent * Weight less than 110 pounds as mandated by AABB guidelines. * Chronic Immunosuppressive medications such as Steroids, Cellcept or Sirolimus. Steroids given for minor illness ok if taken more than 6 weeks before any cytapheresis procedure. Immunosuppressive medications may not be used at the time of the cytapheresis procedure as they decrease circulating white blood cells. * Test results are positive for viral infections such as HIV, Hepatitis B or C and RPR. Researchers are seeking healthy, pristine cells. Due to the ongoing nature of these chronic viral and bacterial infections, the white cell populations in the peripheral blood will change. Researchers want to study changing white cell populations as a factor of aging only and not those altered by infections. * Ongoing risk factors for HIV or Hepatitis B or C such as: intravenous drug use, non-monogamous unprotected intercourse, or chronic use of clotting factor concentrates such as prothrombin complexes, Factor XIII or Factor VIIa. These viruses weaken the immune system and cause changes in the white blood cells. * Risk factors for Creutzfeldt-Jakob disease such as: a relative with the disease, received beef insulin or growth hormone from human pituitary glands, or residency/travel to high risk countries (complete list of countries located in the Cytapheresis Screening manual kept in the NIA apheresis unit). This is a transmittable infectious disease with a very long incubation period. * Major medical illnesses such as any type of liquid or solid tumor cancer, diabetes, history of deep vein thrombosis, organ or bone marrow transplant, or liver, kidney, heart or lung disease. * A medical finding that shows a participant could not safely go through this procedure. (such as Parkinson s disease, dementia or any uncontrolled behavior that would place the participant s safety at risk) * Major infectious diseases such as Chagas disease, babesiosis, syphilis or malaria * Bleeding conditions such as hemophilia or von Willebrand s disease. * Significant abnormalities are found in the results of blood tests such as elevated liver enzymes, abnormal kidney function, positive viral titers, fasting blood glucose greater than 120. * On any medication that can alter white blood cell function such as chronic steroid use, histamine-2 blockers, antivirals or chemotherapy. (complete list located in the Cytapheresis Screening manual stored in the NIA Apheresis unit). In addition, eligible participants may not be able to participate in a specific cytapheresis procedure but might be eligible at a later date for: 1. Pregnancy and Nursing Mothers - Females who are pregnant or who have had a pregnancy in the last 6 weeks are temporarily deferred. They may resume apheresis participation 6 weeks after delivery or cessation of lactation and have been cleared by their obstetrician or primary care physician. 2. Medications: Volunteers taking the following medications would be deferred: * Antibiotics, antifungals, antimalarials: Deferred for 2 weeks after course has been completed and volunteer is feeling well. * Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal or for joint injection. * Hepatitis B immune globulin: Volunteers are deferred 6 months if given after exposure to hepatitis B to insure the volunteer has not been infected. If administered for prophylaxis, no deferral is necessary. * Live Attenuated Virus Vaccinations: Defer for 4 weeks if symptom-free. * Inactivated (Killed Virus) Vaccinations: Defer for 2 weeks if symptom-free. * Rabies Vaccine: Deferred for 1 year if given for rabies exposure; otherwise accept immediately if symptom-free. * Smallpox Vaccine: Deferred until the scab has separated from the skin spontaneously or 21 days from date of immunization, whichever is longer, if volunteer had no other symptoms or complications. Visual verification of absence of vaccine scab is required. If scab was otherwise removed (not spontaneously separated), defer for 2 months after vaccination date. * Blood thinners such as Plavix, Ticlid or Lovenox. Deferral for 5 days after last dose to decrease bleeding risk at needle puncture sites. Participants are not deferred for the use of aspirin or aspirin products. * Experimental Medication or Unlicensed (Experimental) Vaccine is usually associated with a research protocol and the effect on blood donation is unknown. Deferral is one year unless otherwise indicated by the Principal Investigator. 3. Temporary health issues * Infection or fever: Deferred until 2 weeks after antibiotics are completed and volunteer is feeling well. * Surgical Procedures: Deferred for 3 months after procedure and released to return to normal activities by primary care physician or surgeon. * Close contact with someone else s blood, accidental needle-stick, treatment for syphilis or gonorrhea Volunteers are deferred for 6 months to insure they have not been infected. Viral/serology testing will be repeated and verified as negative prior to apheresis procedure. * Factors that are high risk (but are non on-going) for HIV, Hepatitis B or C such as: (Volunteers will be deferred for 6 months after to insure they have not been infected with an infectious disease or virus. Viral testing and annual labs will be repeated and verified as within normal limits prior to apheresis procedure) i. Having sexual contact with anyone who has HIV/AIDS or has had a positive test for the HIV/AIDS virus ii. Received money, drugs or other payment for sex or having sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex iii. Had sexual contact with anyone who has hemophilia or has used clotting factor concentrates. iv. Has used needles to take drugs, steroids or anything NOT prescribed by their doctor or had sexual contact with anyone who has ever used needles to take drugs or steroids, or anything NOT prescribed by their doctor. v. Had sexual contact with or living with anyone who has hepatitis. vi. Had a tattoo using non-sterile needles or reused ink. vii. Had a body piercing that used non-sterile needles or multi-use equipment. viii. Has been in juvenile detention or prison for more than 72 hours. * Had close contact with someone who had a smallpox vaccination such as touching the vaccination site, handling bedding or clothing that has been in contact with an unbandaged vaccination site to insure they have not been infected: Deferral is 2 months if volunteer is symptom-free. * Anemia/Leukopenia/Thrombocytopenia: i. Female volunteers with a hemoglobin of \< 11.0 or hematocrit \<35, or males with a hemoglobin of \<12.5 or hematocrit \<38 may return in 8 weeks to repeat labs to verify anemia. Deferred until values return to the levels stated required levels. ii. White blood cell count \<3.0 in African-American participants or \<3.5 in all other races. Deferred until values return to the levels stated required levels. iii. Platelet count \<150,000. Deferred until values return to the levels stated required levels. iv. Mean Corpuscular Volume (MCV) \<80. Deferred until values return to the levels stated required levels. v. Whole blood donation (450 mL): Deferred for 56 days from date of last donation as mandated by AABB guidelines. vi. Double unit red cell donation: Deferred for 112 days (16 weeks) as mandated by AABB guidelines. vii. Platelet or plasma donation: Deferred for 28 days from date of last donation as mandated by AABB guidelines. viii. Leukocyte donation: Deferred for 56 days from date of last donation as mandated by AABB guidelines. * Received blood transfusion, transplant such as tissue, or had a graft such as bone or skin: Deferral is for 12 months to insure volunteer has not acquired an infectious disease. Annual laboratory testing will be repeated prior to apheresis procedure. * It is less than six weeks since participation in another research study which is felt by the Principal Investigator to be incompatible with this study. (for example: studies that collect blood, investigational drug studies, vaccine trials, etc) 4. Travel: * Malaria-endemic countries: Volunteers who are residents of such countries will be deferred for 3 years after departure from the country if they remain free from unexplained symptoms suggestive for malaria. Residence is defined as a continuous stay of longer than 5 years in a country or countries having any malaria-endemic area. Donors who are not prior residents of malaria-endemic countries and travel to a malaria-endemic area will be deferred for 12 months after departure from that area. The duration of travel to a malaria-endemic area is defined as more than 24 hours to less than 5 years. Note that a passage greater than 24 hours through a malaria-endemic area while on route to a malaria-free area is considered a sufficient possible exposure to trigger deferral. (A complete list of malarial-endemic countries is kept in the Cytapheresis Screening Manual and is stored in the NIA Apheresis Unit.)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institute of Aging, Clinical Research Unit
RECRUITINGBaltimore, Maryland, 21224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?