Investigating Cytokine Genes of Stem Cell Donors

December 11, 2019 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Cytokine Gene Polymorphisms in Allotransplant Donors

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 5, 2003

Study Completion

March 2, 2018

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

March 2, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 030201
  • 03-H-0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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