Investigating Cytokine Genes of Stem Cell Donors
Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stem Cell Transplantation
Phase: N/A
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s): A. John Barrett, M.D., Principal Investigator, Affiliation: National Heart, Lung, and Blood Institute (NHLBI)
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.
Clinical Details
Official title: Cytokine Gene Polymorphisms in Allotransplant Donors
Study design: N/A
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
- INCLUSION CRITERIA:
Participation as a stem cell donor on a Hematology Branch protocol.
For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian.
Informed assent from minors: The process will be explained to the minor on a level of
complexity appropriate for their age and ability to comprehend.
Age greater than or equal to 2 and less than or equal to 80.
EXCLUSION CRITERIA:
Subjects unable to comprehend the investigational nature of the laboratory research.
Locations and Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States
Additional Information
NIH Clinical Center Detailed Web Page
Related publications: SociƩ G, Loiseau P, Tamouza R, Janin A, Busson M, Gluckman E, Charron D. Both genetic and clinical factors predict the development of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Transplantation. 2001 Aug 27;72(4):699-706. Cavet J, Middleton PG, Segall M, Noreen H, Davies SM, Dickinson AM. Recipient tumor necrosis factor-alpha and interleukin-10 gene polymorphisms associate with early mortality and acute graft-versus-host disease severity in HLA-matched sibling bone marrow transplants. Blood. 1999 Dec 1;94(11):3941-6. Cavet J, Dickinson AM, Norden J, Taylor PR, Jackson GH, Middleton PG. Interferon-gamma and interleukin-6 gene polymorphisms associate with graft-versus-host disease in HLA-matched sibling bone marrow transplantation. Blood. 2001 Sep 1;98(5):1594-600.
Starting date: June 2003
Last updated: November 11, 2014
|