PSCCILIANCT06865924
Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
A study testing Use of assembloids as in vitro models to test new pharmacological approaches in people with PSC, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1/10,000. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PSC
- What is being tested?
- Use of assembloids as in vitro models to test new pharmacological approaches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 90 years of age
- Of both sexes
- willingness to sign informed consent for the study; Additional criteria group 1
- Patients with a confirmed aPSC diagnosis Additional criteria group 2
- patients with suspected PSC liver biopsy candidates Additional criteria group 3
- Patients not affected by aPSC listed for the following procedures:
Show all 10Show fewer
- Liver resection for hepatocellular or other hepatic lesions (including secondary effects from other cancers and benign focal lesions, which will result in healthy liver tissue);
- Post-transplant biopsies of healthy liver;
- cholecystectomies. Additional criteria group 4
- Patients previously genotyped in the study "Impact of complete exoma sequencing on clinical management of patient with non-alcoholic liver steatosis and cryptogenic liver disease project code RF-2016-02364358" results carrying gene variants associated with ciliopathies
Who cannot join
- -Positive for chronic viral hepatitis (HCV-RNA and HBsAg).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Luca Valenti, Doctor, 02 5503 6595, luca.valenti@policlinico.mi.it
About this study
Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1/10,000. Biliary disease in PSC is represented by cholestasis, chronic inflammation of the bile ducts, the small tubes through which bile passes, progressive concentric fibrosis around the bile ducts2. This results in an obstruction to the passage of bile, which can lead to the development of cirrhosis with complications related to portal hypertension, cholangitis and often progress to bile duct cancer (cholangiocarcinoma). The only curative therapy in patients with PSC is liver transplantation, since no drug has been shown to be effective in preventing disease progression. The etiology is most likely multifactorial immune-mediated, where the onset of PSC is triggered by environmental factors in a genetically susceptible host2Genome-wide association studies (GWAS) have identified variations at the human leukocyte antigen (HLA) complex on chromosome 6 and several other loci, but these explain only a small part of the heritability of PSC. In most cases, PSC occurs in men in their 30s and 40s who have inflammatory bowel disease (IBD) suggesting a key role of altered intestinal permeability and inflammation. However, approximately 30% of patients do not present colonic inflammation, which is consistent with the heterogeneity of the disease. Preliminary data obtained in our laboratory analyzing a cohort of Italian individuals with atypical PSC (aPSC), identified a suggestive enrichment of rare variants in genes involved in cilia morphogenesis (CEP120 and AHI1). These data are consistent with previous findings, showing the correlation between gene variants involved in ciliopathies, including the DCDC26 gene, and chronic cholestatic disorders that can mimic PSC. Primary cilia are organelles present on the outer membrane of ductal cells, called cholangiocytes. These organelles function as antennas that detect stimuli from bile and transmit information to cells by regulating various signaling pathways involved in secretion, proliferation and apoptosis. Therefore, the alteration of primary cilia plays an important role in the de-differentiation of cholangiocytes and therefore in the development of cholangiopathies, in the invasion of inflammatory cells and in the fibrotic process. However, to date little is known about the contribution of genetic variants to the severity and progression of PSC, perhaps also due to the lack of a reliable model of bile duct. Recently, three-dimensional cell cultures, called organoids, have been proposed as a revolutionary tool in the field of cell biology, as they are able to mimic the corresponding organ in vivo.Organoids can be derived from either induced pluripotent stem cells (iPSCs) or tissue-resident adult stem cells. Compared to conventional 2D cultures and animal models, organoids allow to reproduce the genetic background of the patient in the model, recapitulating in vitro structures and functions similar to in vivo tissues. For this reason, organoids have been exploited in different applications, including drug discovery and testing, precision medicine and cell therapy 9311. However, organoids still show several limitations to model liver diseases. Indeed, they are only able to recapitulate the hepatic epithelial component, cholangiocytes and/or hepatocytes and above all they lack the 3D hepatic microenvironment, such as stromal and immune cells, which play an important role in the pathogenesis of several liver diseases. The present study is part of a project funded by the Regional Foundation for Biomedical Research (FRRB) whose general objective is to generate three-dimensional models of primary sclerosing cholangitis (PSC), called assemblyloids, and to study the cellular and molecular mechanisms through which genetic variants associated with genes involved in ciliopathies accelerate the progression of PSC. Our hypothesis is that the loss of function of cilia in cholangiocytes may represent a link between cellular senescence, development of inflammation, fibrosis and finally liver cancer. The variants related to ciliopathies could lead to an incomplete maturation of cholangiocytes with consequent malfunction that can therefore lead to a chronic inflammation of ductal cells and therefore to a persistent and uncontrolled activation of stromal cells and infiltration of immune cells. Furthermore, the generation of assemblyloids capable of reproducing native tissue as faithfully as possible will provide a new in vitro model for testing new pharmacological approaches aimed at correcting genetic mutations for improved precision medicine.
- Conditions
- PSC
- Being tested
- Use of assembloids as in vitro models to test new pharmacological approaches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of assembloids as in vitro models to test new pharmacological approachesOther
Using extracellular vesicles containing the CRISPR/Cas9 genome editing system that by faithfully reproducing the in vivo part will allow a more faithful response than the use of conventional 2D model, organoids or animal model.
| Study group | Role | What they receive |
|---|---|---|
| Behaviour of the genetic variants involved in ciliopathies. | Experimental | Study of the onset and progression of aPSC by analyzing in three-dimensional models called assembloids:
* Morphology of primary eyelashes
* Differentiation of cholangiocytes
* Activation of fibrogenesis
* Infiltration of immune cells Receives: Other: Use of assembloids as in vitro models to test new pharmacological approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantify the impact of genetic risk factors for PSC and the role genetic variants
The different inclusion criteria are able to identify the number of individuals at risk for PSC among patients. Understand the impact of individual genetic variants on PSC risk and rates variants associated with ciliopathies on aPSC phenotype within the variant carrier group compared to the non-carrier group.
Measured: 48 months
Secondary outcomes (1)
The quantify the impact of pharmacological tests on extracellular vesicles
The impact of genetic risk factors for PSC and their interaction will be realized by evaluating the extracellular vesicles of the CRISPR/Cas9 genome editing system to correct mutations involved in ciliopathies.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSCStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Valenti:, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865924
- Sponsor's protocol ID
- CILIA
- Acronym
- CILIA
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT06865924
- Acronym / sponsor ID
- CILIA / CILIA
- Conditions
- PSC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1/10,000. Biliary disease in PSC is represented by cholestasis, chronic inflammation of the bile ducts, the small tubes through which bile passes, progressive concentric fibrosis around the bile ducts2. This results in an obstruction to the passage of bile, which can lead to the development of cirrhosis with complications related to portal hypertension, cholangitis and often progress to bile duct cancer (cholangiocarcinoma). The only curative therapy in patients with PSC is liver transplantation, since no drug has been shown to be effective in preventing disease progression. The etiology is most likely multifactorial immune-mediated, where the onset of PSC is triggered by environmental factors in a genetically susceptible host2Genome-wide association studies (GWAS) have identified variations at the human leukocyte antigen (HLA) complex on chromosome 6 and several other loci, but these explain only a small part of the heritability of PSC. In most cases, PSC occurs in men in their 30s and 40s who have inflammatory bowel disease (IBD) suggesting a key role of altered intestinal permeability and inflammation. However, approximately 30% of patients do not present colonic inflammation, which is consistent with the heterogeneity of the disease. Preliminary data obtained in our laboratory analyzing a cohort of Italian individuals with atypical PSC (aPSC), identified a suggestive enrichment of rare variants in genes involved in cilia morphogenesis (CEP120 and AHI1). These data are consistent with previous findings, showing the correlation between gene variants involved in ciliopathies, including the DCDC26 gene, and chronic cholestatic disorders that can mimic PSC. Primary cilia are organelles present on the outer membrane of ductal cells, called cholangiocytes. These organelles function as antennas that detect stimuli from bile and transmit information to cells by regulating various signaling pathways involved in secretion, proliferation and apoptosis. Therefore, the alteration of primary cilia plays an important role in the de-differentiation of cholangiocytes and therefore in the development of cholangiopathies, in the invasion of inflammatory cells and in the fibrotic process. However, to date little is known about the contribution of genetic variants to the severity and progression of PSC, perhaps also due to the lack of a reliable model of bile duct. Recently, three-dimensional cell cultures, called organoids, have been proposed as a revolutionary tool in the field of cell biology, as they are able to mimic the corresponding organ in vivo.Organoids can be derived from either induced pluripotent stem cells (iPSCs) or tissue-resident adult stem cells. Compared to conventional 2D cultures and animal models, organoids allow to reproduce the genetic background of the patient in the model, recapitulating in vitro structures and functions similar to in vivo tissues. For this reason, organoids have been exploited in different applications, including drug discovery and testing, precision medicine and cell therapy 9311. However, organoids still show several limitations to model liver diseases. Indeed, they are only able to recapitulate the hepatic epithelial component, cholangiocytes and/or hepatocytes and above all they lack the 3D hepatic microenvironment, such as stromal and immune cells, which play an important role in the pathogenesis of several liver diseases. The present study is part of a project funded by the Regional Foundation for Biomedical Research (FRRB) whose general objective is to generate three-dimensional models of primary sclerosing cholangitis (PSC), called assemblyloids, and to study the cellular and molecular mechanisms through which genetic variants associated with genes involved in ciliopathies accelerate the progression of PSC. Our hypothesis is that the loss of function of cilia in cholangiocytes may represent a link between cellular senescence, development of inflammation, fibrosis and finally liver cancer. The variants related to ciliopathies could lead to an incomplete maturation of cholangiocytes with consequent malfunction that can therefore lead to a chronic inflammation of ductal cells and therefore to a persistent and uncontrolled activation of stromal cells and infiltration of immune cells. Furthermore, the generation of assemblyloids capable of reproducing native tissue as faithfully as possible will provide a new in vitro model for testing new pharmacological approaches aimed at correcting genetic mutations for improved precision medicine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behaviour of the genetic variants involved in ciliopathies. | Experimental | Other: Use of assembloids as in vitro models to test new pharmacological approachesStudy of the onset and progression of aPSC by analyzing in three-dimensional models called assembloids: * Morphology of primary eyelashes * Differentiation of cholangiocytes * Activation of fibrogenesis * Infiltration of immune cells |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between 18 and 90 years of age
- Of both sexes
- willingness to sign informed consent for the study; Additional criteria group 1
- Patients with a confirmed aPSC diagnosis Additional criteria group 2
- patients with suspected PSC liver biopsy candidates Additional criteria group 3
Key exclusion criteria (1 listed)
- -Positive for chronic viral hepatitis (HCV-RNA and HBsAg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of assembloids as in vitro models to test new pharmacological approachesUsing extracellular vesicles containing the CRISPR/Cas9 genome editing system that by faithfully reproducing the in vivo part will allow a more faithful response than the use of conventional 2D model, organoids or animal model. | Other | Behaviour of the genetic variants involved in ciliopathies. |
Primary outcome
The quantify the impact of genetic risk factors for PSC and the role genetic variants
Time frame: 48 months
The different inclusion criteria are able to identify the number of individuals at risk for PSC among patients. Understand the impact of individual genetic variants on PSC risk and rates variants associated with ciliopathies on aPSC phenotype within the variant carrier group compared to the non-carrier group.
1 secondary outcome
The quantify the impact of pharmacological tests on extracellular vesicles
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of assembloids as in vitro models to test new pharmacological approaches in people with PSC, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Vittorio Carlo Valenti, Doctor (02 5503 6595 ext. 56595, luca.valenti@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quantify the impact of genetic risk factors for PSC and the role genetic variants (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.