Liver DiseasesNCT00011284
Mechanisms of Inflammatory Liver Injury
An observational study of Liver Diseases, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Only blood from normal subjects will be used in the in vitro experiments.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Liver Diseases
- Keywords
- Liver, Inflammation, Endotoxin, Neutrophils, Hepatocytes
- Medical subject headings
- Liver Diseases, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2001 (estimated)
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011284
- Sponsor's protocol ID
- 6091-CP-001
- Status last verified
- Sep 2002
- First submitted
- 15 Feb 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Inflammatory Liver Injury
- ClinicalTrials.gov ID
- NCT00011284
- Acronym / sponsor ID
- 6091-CP-001
- Conditions
- Liver Diseases
- Keywords
- Liver, Inflammation, Endotoxin, Neutrophils, Hepatocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study completion
- Nov 2001
- First posted
- 19 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.