Using liver organoids to study non-alcoholic steatohepatitis
Human Liver ORganoids as a Model to Study the Role of the I148M Variant of the PNPLA3 Gene in the Development of Non-Alcoholic SteatOhepatitis (NASH)
This study is trying to create mini-livers in the lab to see how different factors and genes affect the early stages of non-alcoholic steatohepatitis (NASH) in order to find new ways to track liver damage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06856252 on ClinicalTrials.gov |
What this trial studies
This study aims to create and analyze three-dimensional liver models, known as 'assembloids', which combine various liver cell types to mimic the early stages of non-alcoholic steatohepatitis (NASH). The models will be developed using clinical samples and will be exposed to environmental factors like excess fatty acids and cholesterol to simulate altered lipid metabolism. Additionally, the study will investigate genetic variants associated with NASH, such as PNPLA3, to identify potential biomarkers for liver damage progression.
Who should consider this trial
Good fit: Ideal candidates include adult patients undergoing liver biopsy for suspected NASH or liver resection for other liver conditions.
Not a fit: Patients with chronic viral hepatitis or other specific liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and early detection of non-alcoholic steatohepatitis, potentially guiding better treatment strategies.
How similar studies have performed: While there have been studies on liver organoids, this specific approach to modeling NASH with a focus on genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, Milano
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica — Milan, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Vittorio Carlo Valenti
- Email: luca.valenti@policlinico.mi.it
- Phone: 02 5503 6595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.