Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104325
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2005-02-24
Brief Title:
Cytapheresis of Volunteer Donors
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytapheresis of Volunteer Donors
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
- 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
Detailed Description:
Cytapheresis is an automated methodprocess 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-AG-N316 | None | None | None |