Healthy VolunteersNCT00104325
Cytapheresis of Volunteer Donors
An observational study of Healthy Volunteers, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2003to not given
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
- 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.
- 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)
- Having sexual contact with anyone who has HIV/AIDS or has had a positive test for the HIV/AIDS virus
- 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
- Had sexual contact with anyone who has hemophilia or has used clotting factor concentrates.
- 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.
- Had sexual contact with or living with anyone who has hepatitis.
- Had a tattoo using non-sterile needles or reused ink.
- Had a body piercing that used non-sterile needles or multi-use equipment.
- 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:
- 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.
- 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.
- Platelet count <150,000. Deferred until values return to the levels stated required levels.
- Mean Corpuscular Volume (MCV) <80. Deferred until values return to the levels stated required levels.
- Whole blood donation (450 mL): Deferred for 56 days from date of last donation as mandated by AABB guidelines.
- Double unit red cell donation: Deferred for 112 days (16 weeks) as mandated by AABB guidelines.
- Platelet or plasma donation: Deferred for 28 days from date of last donation as mandated by AABB guidelines.
- 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)
- 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.)
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, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
NIA Studies Recruitment, 410-350-3941, niastudiesrecruitment@mail.nih.gov
About this study
Background:
- National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost.
Read more
Objectives:
- To use cytapheresis to collect white blood cells for study.
Eligibility:
- Healthy blood donors at least 18 years of age.
Design:
- Participants will be screened according to the usual blood donation procedures.
- Participants will provide white blood cells through cytapheresis. The blood cells will be collected in a machine that separates the white blood cells from the rest of the blood. The rest of the blood will be returned to the donor.
- Participants may have this type of donation every 56 days (six times per year). They will be asked to become a repeat donor. A donation schedule may be set up.
- Once a year, participants will have blood tests to continue to be eligible as a donor.
Read the detailed description
Cytapheresis is an automated method/process of cell removal and collection that involves a continuous flow cell separation by centrifugation and the withdrawal of a particular blood component. This allows blood components not collected to be continuously
returned to the donor. Guidance and recommendations for the performance of these procedures are provided in detail in the Standards of the American Association of Blood Banks (AABB) and in the Code of Federal Regulations (CFR).
The study objective is to provide white blood cells obtained by cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.
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.
We will collect blood component cells for distribution to NIA research investigators for their studies of the immune system. We will be performing cytapheresis for the collection of 3 7 blood component packs per week. We will need to maintain an active volunteer pool of approximately 200 active volunteers.
- Conditions
- Healthy Volunteers
- Keywords
- Cell Separation, White Blood Cells, Immune Studies, Cell Function, Machine Collection, 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 |
|---|---|---|
| 1 | white blood cells obtained through cytapheresis by healthy males and females 18 years and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide white blood cells to National Institute on Aging (NIA) researchers for other in-vitro research studies.
Indefinite
Measured: Indefinite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2005 (estimated)
- Study start30 Jan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chee W Chia, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104325
- Sponsor's protocol ID
- 999903316
- Other IDs
- 03-AG-N316
- Status last verified
- 6 Aug 2026
- First submitted
- 24 Feb 2005
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytapheresis of Volunteer Donors
- ClinicalTrials.gov ID
- NCT00104325
- Acronym / sponsor ID
- 999903316
- Conditions
- Healthy Volunteers
- Keywords
- Cell Separation, White Blood Cells, Immune Studies, Cell Function, Machine Collection, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 30 Jan 2003 (actual)
- First posted
- 25 Feb 2005 (estimated)
- 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:
- National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost.
Objectives:
- To use cytapheresis to collect white blood cells for study.
Eligibility:
- Healthy blood donors at least 18 years of age.
Design:
- Participants will be screened according to the usual blood donation procedures.
- Participants will provide white blood cells through cytapheresis. The blood cells will be collected in a machine that separates the white blood cells from the rest of the blood. The rest of the blood will be returned to the donor.
- Participants may have this type of donation every 56 days (six times per year). They will be asked to become a repeat donor. A donation schedule may be set up.
- Once a year, participants will have blood tests to continue to be eligible as a donor.
Detailed description
Cytapheresis is an automated method/process of cell removal and collection that involves a continuous flow cell separation by centrifugation and the withdrawal of a particular blood component. This allows blood components not collected to be continuously
returned to the donor. Guidance and recommendations for the performance of these procedures are provided in detail in the Standards of the American Association of Blood Banks (AABB) and in the Code of Federal Regulations (CFR).
The study objective is to provide white blood cells obtained by cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.
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.
We will collect blood component cells for distribution to NIA research investigators for their studies of the immune system. We will be performing cytapheresis for the collection of 3 7 blood component packs per week. We will need to maintain an active volunteer pool of approximately 200 active volunteers.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –white blood cells obtained through cytapheresis by healthy males and females 18 years and older |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (53 listed)
- 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.
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
Provide white blood cells to National Institute on Aging (NIA) researchers for other in-vitro research studies.
Time frame: Indefinite
Indefinite
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided. The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.
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Screening Protocol
Pain
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.
Chee W Chia, M.D. principal investigator
National Institute on Aging (NIA)
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 Healthy Volunteers, run by National Institute on Aging (NIA) 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 3 inclusion and 53 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 Linda M Zukley, Ph.D. ((410) 350-3983, zukleylm@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provide white blood cells to National Institute on Aging (NIA) researchers for other in-vitro research studies. (time frame: Indefinite). 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 29 Oct 2026.