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โ† Trials
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Human Liver ORganoids as a Model to Study the Development of Non-Alcoholic SteatOhepatitis (NASH)

RecruitingNAAges 18 Years - anyAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Poโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The primary objective of the study is to generate and characterize three-dimensional models, called "assembloids", composed of the main liver cell populations (in particular from the co-culture of organoids with stellate cells, responsible for fibrogenesis, deriving from clinical samples). These models will be used in order to imitate the first phases of the onset of steatohepatitis, in conditions of altered lipid metabolism (induced through exposure to the main environmental determinants of this condition: excess fatty acids, fructose, cholesterol) in the presence or absence of the mutation I148M of PNPLA3. Other genetic variants will also be analyzed, such as TM6SF2, MBOAT7 and GCKR, which have previously been correlated with the development of non-alcoholic steatohepatitis. Further objectives will be: 1) identify new biomarkers of pathological activation of human stellate cells and p

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Liver resection to isolate cells
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Where

1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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