TIssue Models for Invasive Disease (TIMID)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The human immune response to bacterial blood stream infection (sepsis) and systemic viral infection are fairly well understood, but we lack details on the most early 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 spleen 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 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. In order to move novel treatment strategies into human trials, we propose to test early events during infection using human spleens and the cells and tissues derived thereof. This research is expected to provide data on the relevance of the early events in bacterial and viral disease, in particular on the role of immune cells. The research includes work with human cells and tissue obtained from human spleens. In these settings, we will test pharmacological prevention and treatment of severe bacterial or viral infection (sepsis). The expected outcome of this work on human organs and tissue is expected to provide evidence that allows to move new treatment options into clinical trial. This study is a preclinical research project and does not involve any intervention on patients, but it involves human tissue. The source of the human splenic tissue for our research will be spleen tissue removed during radical surgery. The present application relates exclusively to the ethical approval for the use of spleen tissue removed during radical surgery and discarded. The utilisation of the spleen or splenic tissue for research purposes does not alter in any way the surgical procedures at any stage and importantly the research will involve only anonymity samples.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The samples included in this project will be from patients undergoing elective surgery in the HPB Unit of the Leicester General Hospital.

• Spleen samples from radical surgery are adult age (18-80 years)

• Presence of splenic tissue in the discarded material after hepato-pancreato-biliary surgery.

Locations
Other Locations
United Kingdom
UHL NHS Trust - Leicester General Hospital
RECRUITING
Leicester
Contact Information
Primary
Marco Oggioni
mro5@leicester.ac.uk
0
Time Frame
Start Date: 2018-08-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 24
Treatments
Trial Participants
Overall Description of Trial Participants: The spleen organ samples included in this project will be from patients undergoing elective surgery for a lesion in the pancreas in the HPB Unit of the Leicester General Hospital. No change in the surgical procedure or recruiting results from this study and the use of the samples.~Inclusion Criteria: The samples included in this project will be from patients undergoing elective surgery in the HPB Unit of the Leicester General Hospital. The criteria for inclusion of spleen samples from radical surgery are adult age and presence of splenic tissue in the discarded material after hepato-pancreato-biliary surgery.~Exclusion Criteria: The main exclusion criterion is acute invasive bacterial and viral infection, but these patients are automatically excluded from major surgery. Vulnerable groups will not be recruited.
Related Therapeutic Areas
Sponsors
Collaborators: University of Nottingham, University Hospitals, Leicester
Leads: University of Leicester

This content was sourced from clinicaltrials.gov