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Cytokine Gene Polymorphisms in Allotransplant Donors


N/A
2 Years
80 Years
Not Enrolling
Both
Stem Cell Transplantation

Thank you

Trial Information

Cytokine Gene Polymorphisms in Allotransplant Donors


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

A. John Barrett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

030201

NCT ID:

NCT00353821

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Stem Cell Transplantation
  • Tumor Necrosis Factor Alpha (TNF-Alpha)
  • Interferon-Gamma (IFN-Gamma)
  • Interleukin-10 (IL-10)
  • Interleukin-6 (IL-6)
  • Interleukin-1 (IL-1 Ra)
  • Interleukin-1 Receptor Antagonist (IL-1 Ra)
  • Vitamin D Receptor (VitD R)

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892