Tissue Models for Liver Disease

NCT05255042 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-05-11

No results posted yet for this study

Summary

The human immune response to bacterial and viral local and systemic infection are fairly well understood, but we lack details on the earliest phases. Better knowledge of these events would be important for the prevention and treatment of severe bacterial or viral disease. From models of infection, we have data showing that bacteria replicate in a specific type of cells in the liver from where the bacteria then seed to the blood to cause blood stream infection. In order to gain more relevant data for humans, we have developed a spleen and liver perfusion model using pig organs. This model confirms our previous work and most importantly will now allow us to study these events in human organs.

Primary Objectives: The primary objective of the study is to identify therapies acting on the initial events during invasive bacterial and viral infection.

Secondary Objectives: The secondary objective of this study is to provide novel in vitro and ex vivo models of human liver macrophages to study the impact of therapies for invasive infection.

The Primary Endpoint of the study is to increase the resistance of liver macrophages to infection at least tenfold after treatment.

The Primary Outcome Measure of the study is the reduction of bacterial or viral load at pre-determined time-points.

Conditions

Interventions

OTHER

organ and tissue sample collection only

Collection of liver segments removed by radical surgery of hepatic lobes, but not submitted to pathology

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER
  • University of Leicester

    lead OTHER

Principal Investigators

  • Marco R Oggioni, MD · University of Leicester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2025-06-25
Completion
2025-06-25

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255042 on ClinicalTrials.gov