Cytapheresis of Volunteer Donors

NCT00104325 | Recruiting

• 2 other identifiers: 99990331603-AG-N316
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers

Keywords

Cell Separation; White Blood Cells; Immune Studies; Cell Function; Machine Collection; Natural History

Outcome Measures

Primary Outcomes (1)

• Provide white blood cells to National Institute on Aging (NIA) researchers for other in-vitro research studies.

  Indefinite

  Indefinite

Study Arms (1)

1

white blood cells obtained through cytapheresis by healthy males and females 18 years and older

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

• Chee W Chia, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda M Zukley, Ph.D.

CONTACT

(410) 350-3983; zukleylm@mail.nih.gov

Chee W Chia, M.D.

CONTACT

(410) 350-7376; chiac@grc.nia.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2005
• First Posted: February 25, 2005
• Study Start: January 30, 2003
• Last Updated: April 16, 2026

Record last verified: 2026-03-18

Locations

US (1)