Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353821
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2006-07-18
Brief Title:
Investigating Cytokine Genes of Stem Cell Donors
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytokine Gene Polymorphisms in Allotransplant Donors
Status:
COMPLETED
Status Verified Date:
2018-03-02
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:
This study seeks to investigate the factors that may account for the differences in the way a stem cell recipient s immune system works after a transplant It will focus on cytokine genes which give specific instructions to the genes and which may influence immune system response More specifically the purpose of the study is to find out how gene polymorphisms gene variations among the population affect the success or failure of a stem cell transplant
Study participants will have donated blood for a stem cell transplant They will be asked to give consent for NIH personnel to run special tests on these blood samples which will have been placed in storage It is hoped that blood samples will be studied from 600 stem cell donors
Study participants will have donated blood for a stem cell transplant They will be asked to give consent for NIH personnel to run special tests on these blood samples which will have been placed in storage It is hoped that blood samples will be studied from 600 stem cell donors
Detailed Description:
The NHLBI Stem Cell Allotransplantation Program is researching methods to improve allogeneic stem cell transplantation We are particularly interested in identifying factors which result in individual variability in outcomes Cytokines are biological modulators of the immune system known to influence various phases of the immune response Normal variations in the genetic material coding for cytokines Cytokine Gene Polymorphisms or CGPs are believed to account for some of the differences in the inflammatory response between individuals In the future we hope to tailor stem cell transplantation to take into account these immunological profiles In order to characterize the effect of any such intervention we first need to better understand the role CGPs play in immune responses in normal healthy persons This involves testing for the presence or absence of a polymorphism in healthy individuals and comparing with a validated in vitro assay None of these polymorphisms are associated with known clinical disease to be classifiable as a genetic defect Moreover we will not correlate these polymorphisms with clinical studies to identify traits in the sample donors We plan to utilize stored blood samples from stem cell transplant donors who have previously participated on a hematology branch protocol as well as consent future donors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-H-0201 | None | None | None |