Cytapheresis of Volunteer Donors

This study is currently recruiting participants.
Verified October 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00104325
First received: February 24, 2005
Last updated: May 23, 2013
Last verified: October 2012

February 24, 2005
May 23, 2013
January 2003
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Mechanism to collect and process components from healthy donors for distribution for in vitro research [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00104325 on ClinicalTrials.gov Archive Site
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Cytapheresis of Volunteer Donors
Cytapheresis of Volunteer Donors

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).

This study is designed to provide white blood cells obtained by Cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.

The subject population consists of healthy males and females 18 years and older. Study subjects are anticipated to be NIA employees, hospital employees, students, and non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be to maintain 200 active donors. Donors are screened initially and annually by a health history questionnaire and blood and urine tests to detect any obvious blood diseases, bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.

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).

This study is designed to provide white blood cells obtained by Cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.

The subject population consists of healthy males and females 18 years and older. Study subjects are anticipated to be NIA employees, hospital employees, students, and non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be to maintain 200 active donors. Donors are screened initially and annually by a health history questionnaire and blood and urine tests to detect any obvious blood diseases, bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.

Observational
Time Perspective: Prospective
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Cytapheresis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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  • Eligibility Criteria:

After receiving test results, the Principal Investigator or designee completes the On Study Eligibility Form and authorizes eligibility. Study eligibility will be determined in accordance with blood donation guidelines recommended by the AABB and Code of Federal Regulations (CFR).

Exclusion Criteria:

Significant abnormalities are found on the health history questionnaire or in the results of blood tests.

Pregnant or nursing mother.

Inadequate venous access for the cell collection procedure.

Severe infection in the past two months.

On any medication that can alter white blood cell function.

A medical finding that shows a participant could not go through this procedure.

Unable to provide informed consent.

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.

Test results are positive for viral infections.

Both
18 Years and older
No
Contact: Josephine M Egan, M.D. (410) 558-8414 eganj@mail.nih.gov
United States
 
NCT00104325
999903316, 03-AG-N316
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
National Institute on Aging (NIA)
Not Provided
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
National Institutes of Health Clinical Center (CC)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP