- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011284
Mechanisms of Inflammatory Liver Injury
June 23, 2005 updated by: National Institute of Environmental Health Sciences (NIEHS)
White blood cells can cause liver damage if they inappropriately accumulate in the liver in large numbers.
Such an event can occur if an individual's blood is exposed to endotoxin, a substance released from the cell walls of many species of bacteria.
The purpose of this study is to isolate neutrophils, an important white blood cell, from the blood of normal volunteers, and put them in tissue culture with isolated liver cells.
The experiments will determine how endotoxin can increase the ability of neutrophils to damage liver cells.
All studies supported by this grant will be done with isolated cells in tissue culture.
This experimental model will reveal possible mechanisms that can in the future be evaluated in human diseases such as bacterial sepsis.
Study Overview
Status
Completed
Conditions
Detailed Description
Neutrophils will be isolated from normal human volunteers and placed in cell culture with isolated hepatocytes or C3A cells (hepatoblastoma cell line that exhibit many characteristics of normal hepatocytes).
These experiments will evaluate the mechanisms by which neutrophil adhere to the surface of hepatocytes, and the mechanisms by which the attached neutrophils can damage or kill the hepatocytes.
Mechanisms of adhesion will involve understanding of the chemokines released by the hepatocytes that stimulate neutrophil adhesiveness, the cytokines that activate hepatocytes to express chemokines and adhesion molecules, the adhesion receptors on the neutrophil surface that are able to recognize the adhesion molecules on the hepatocyte surface, and the ability of adhesion to enhance and focus cytotoxic chemicals coming from the stimulated neutrophils.
In addition, the role endotoxin can play in these sequence of events is being studies, and the specific cytotoxic mechanisms released by the neutrophils are under study.
As noted in the brief summary, this grant only supports use of human cells in vitro (i.e., all experiments will be done in tissue culture).
The purpose of working with this experimental model is to define what mechanisms should in future experiments be evaluated in patients with endotoxin induced disease.
Study Type
Observational
Enrollment
50
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
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Only blood from normal subjects will be used in the in vitro experiments.
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.
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 Completion
November 1, 2001
Study Registration Dates
First Submitted
February 15, 2001
First Submitted That Met QC Criteria
February 16, 2001
First Posted (Estimate)
February 19, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
September 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6091-CP-001
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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