Cytapheresis of Volunteer Donors
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Purpose
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.
| Condition |
|---|
|
Cytapheresis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Cytapheresis of Volunteer Donors |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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.
Contacts and Locations| Contact: Josephine M Egan, M.D. | (410) 558-8414 | eganj@mail.nih.gov |
| United States, Maryland | |
| National Institute of Aging, Clinical Research Unit | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Josephine M Egan, M.D. | National Institute on Aging (NIA) |
More Information
No publications provided
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ) |
| ClinicalTrials.gov Identifier: | NCT00104325 History of Changes |
| Other Study ID Numbers: | 999903316, 03-AG-N316 |
| Study First Received: | February 24, 2005 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Cytapheresis Blood Collection Volunteer Donor White Blood Cells |
ClinicalTrials.gov processed this record on May 19, 2013