Human Liver ORganoids as a Model to Study the Development of Non-Alcoholic SteatOhepatitis (NASH)
Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Feb 25, 2025
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a condition called non-alcoholic steatohepatitis (NASH), which is a type of liver disease related to fat buildup in the liver. Researchers are creating special 3D models, known as "assembloids," that mimic the early stages of NASH. They will use these models to explore how different factors, like certain fats and sugars, influence the disease. The goal is to identify new markers that could help doctors assess liver damage and to understand the genetic factors that contribute to NASH's progression.
To participate in this trial, you should be an adult who has agreed to take part and is undergoing specific liver procedures, such as a biopsy to check for NASH or a liver surgery. You will need to provide a blood sample and some DNA for analysis. However, if you have other liver diseases, like chronic viral hepatitis, you won't be eligible. As a participant, you can expect to contribute to important research that could help improve the understanding and treatment of liver diseases in the future.
Gender
ALL
Eligibility criteria
- Adult patients who have given consent to participate in the study and listed for the following procedures will be included:
- • liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;
- • liver resection for hepatocarcinoma or other liver lesions (including secondaries from other neoplasms and benign focal lesions, which will allow obtaining healthy starting liver tissue);
- • post-transplant healthy liver biopsies;
- • cholecystectomies.
- It will also be required:
- • availability to sign informed consent for the study
- • availability of DNA sample for genetic analysis and clinical data,
- • blood sampling for genetic and epigenetic analyzes and analysis of non-coding RNAs (lncRNAs, miRNAs and circRNAs).
- Patients will be excluded who present:
- • positivity for chronic viral hepatitis (HCV-RNA and/or HBsAg);
- • positivity to other liver diseases such as autoimmune and viral hepatitis (hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, Wilson's disease.
About Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is a prestigious research and clinical care institution based in Milan, Italy. Renowned for its commitment to advancing medical knowledge and improving patient outcomes, the foundation integrates cutting-edge research with high-quality healthcare services. It serves as a hub for innovative clinical trials, fostering collaborations among healthcare professionals, researchers, and academic institutions. With a focus on various therapeutic areas, the foundation aims to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, Milano, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported