View Clinical Trial (Medical Research Study)
Cytapheresis of Volunteer Donors
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21224 |
| Conditions: |
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Cytapheresis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00104325 |
| Primary Contact: |
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Principal Investigator
Josephine M Egan, M.D.
National Institute on Aging (NIA)
Josephine M Egan, M.D.
Phone: (410) 558-8414
Email: eganj@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21224
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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