Using liver organoids to study non-alcoholic steatohepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD

  This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.

  Recruiting at 3 sites University of Nottingham · Nottingham, United Kingdom and 2 other locations · NCT07093346

• Prospective NAFLD/NASH patient cohort and biobank

  This project will collect medical data and blood/tissue samples from adults with NAFLD/NASH to create a long-term resource to help researchers understand disease course and causes.

  Recruiting Fondazione Epatocentro Ticino · Lugano, Canton Ticino · NCT07051863

• Digital prevention for liver disease management

  This study is testing a new way to help people with liver disease by using a mobile app for patients and a dashboard for doctors to see if it improves their care and health outcomes.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, Lazio · NCT06879236

• Examining Non-Alcoholic Fatty Liver Disease in Patients with Inflammatory Bowel Disease

  This study looks at how common Non-Alcoholic Fatty Liver Disease is in people with Inflammatory Bowel Disease to see how gut health might affect liver health.

  Recruiting Centre Hospitalier Universitaire Saint Pierre · Brussels · NCT06814600

• Improving care for Veterans with non-alcoholic fatty liver disease

  This study tests a new way to help Veterans with non-alcoholic fatty liver disease by using a structured plan to improve diagnosis and treatment compared to regular care.

  Recruiting VA Office of Research and Development · Houston, Texas · NCT06671886

• Ultraportable Hepatoscope ultrasound for measuring liver fat in MASLD/MASH

  The Hepatoscope device will be tested to see if it can measure liver fat accurately in adults with MASLD/MASH compared with MRI-PDFF.

  Recruiting at 2 sites E-Scopics · Angers and 2 other locations · NCT06661655

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.