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Active, not recruiting Observational

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

NCT06913699 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-04-01
Last updated
2025-04-08

Condition(s) studied

Non-alcoholic Fatty Liver Disease (NAFLD)

Investigational drug(s) / intervention(s)

Ultrasonund-guided percutaneous liver biopsy

Ultrasonund-guided percutaneous liver biopsy: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Clinical diagnosis of Non-Alcoholic Fatty Liver Disease * Age 18-65 years Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Mertk expression levels of liver tissues — From enrollment to the end of treatment at 4 weeks
    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.
  • C-Kit expression levels of liver tissues — From enrollment to the end of treatment at 4 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital (East Hospital Affiliated To Tongji University) Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06913699 on ClinicalTrials.gov ↗ ← All trials in China