Cytapheresis of Volunteer Donors

Healthy Volunteers Clinical Trial

Official title: Cytapheresis of Volunteer Donors

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT00104325
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Terri Laporta
• Phone: (410) 350-3929
• Email: terri.laporta@nih.gov
• Status: Recruiting
• Start date: January 30, 2003