The Ameliorative Effect of C-Kit (+) Hepatic Endothelial Cells With Mertk Deficiency on Nonalcoholic Steatohepatitis

NCT06913699 | Active Not Recruiting DMC

• 1 other identifier: Approval No.2024YS-050
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of non-alcoholic fatty liver disease (NAFLD) has been steadily increasing, with 10-20% of affected individuals progressing to non-alcoholic steatohepatitis (NASH). NASH is pathologically characterized by hepatic inflammation, steatosis, and hepatocyte injury. Furthermore, this condition carries a significant risk of progression to advanced hepatic fibrosis (pathological Scheuer fibrosis stage F≥3), cirrhosis, and even hepatocellular carcinoma (HCC). In recent years, NASH has emerged as the leading contributor to the growing burden of cirrhosis worldwide, representing a major public health challenge. Despite the high incidence and clinical severity of NAFLD, there are currently no FDA-approved therapeutic agents for its management. Therefore, elucidating the molecular mechanisms underlying NAFLD-associated NASH progression is critical for developing targeted pharmacological interventions capable of preventing, ameliorating, or potentially reversing disease progression.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (2)

• Mertk expression levels of liver tissues

  1. Liver Biopsy and Tissue Collection: Ultrasound-guided liver biopsy in 6 NAFLD patients. Histopathological evaluation (HE, Masson staining) for NASH and fibrosis (NAS and Scheuer scoring). Clinical data collection and liver tissue storage (-80°C). 2. Expression Analysis of Mertk: Immunofluorescence staining of liver tissues. 3. Statistical Analysis: Compare Mertk expression levels between mild and severe NAFLD patients.

  From enrollment to the end of treatment at 4 weeks

• C-Kit expression levels of liver tissues

  1. Liver Biopsy and Tissue Collection: Ultrasound-guided liver biopsy in 6 NAFLD patients. Histopathological evaluation (HE, Masson staining) for NASH and fibrosis (NAS and Scheuer scoring). Clinical data collection and liver tissue storage (-80°C). 2. Expression Analysis of C-Kit: Immunofluorescence staining of liver tissues. 3. Statistical Analysis: Compare C-Kit expression levels between mild and severe NAFLD patients.

  From enrollment to the end of treatment at 4 weeks

Interventions

Ultrasonund-guided percutaneous liver biopsy PROCEDURE

All patients completed blood routine, coagulation function and liver biochemical indexes before surgery, and informed the patients and their families about the purpose and risks of surgery, and signed an informed consent. During the procedure, the patient was placed in the left lateral decubitus position. After locating by ultrasound and routine disinfection, 0.5% lidocaine was used for local anesthesia. Under the guidance of ultrasound, a 16G disposable biopsy needle (SC1620) was inserted into the liver parenchyma, and the biopsy gun was started and fired for sampling. The removed liver tissue was fixed in 4% formaldehyde solution and sent to the pathology department. The patient's puncture site was disinfected and covered with sterile dressing, and the abdominal band was bandaged. The patients were instructed to stay in bed for 24 hours after operation, closely observe whether there was pain and bleeding after operation, and monitor electrocardiogram for 24 hours.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comprised adults with NAFLD confirmed by imaging (ultrasound, CT, or MRI), excluding secondary causes (e.g., alcohol consumption \>30/20 g/day for men/women, viral hepatitis, or steatogenic medications). . Exclusion criteria included Cirrhosis (compensated or decompensated), hepatocellular carcinoma, primary biliary cholangitis, primary sclerosing cholangitis, recent history of illicit drug use, current pregnancy or breastfeeding, severe comorbidities. NAFLD severity was categorized using non-invasive fibrosis scores (NFS) or liver biopsy (steatosis, inflammation, fibrosis staging).

You may qualify if:

• Clinical diagnosis of Non-Alcoholic Fatty Liver Disease
• Age 18-65 years

You may not qualify if:

• Cirrhosis (compensated or decompensated)
• Hepatocellular carcinoma
• Active viral hepatitis (HBV, HCV)
• Primary biliary cholangitis
• Primary sclerosing cholangitis
• Recent history of illicit drug use
• Alcohol intake≥20 g/day for women and ≥30 g/day for men
• Current pregnancy or breastfeeding
• Severe comorbidities.

Sponsors & Collaborators

• Shanghai East Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Shanghai East Hospital (East Hospital Affiliated To Tongji University)

Shanghai, Shanghai Municipality, 200120, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)