Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and evaluate the dose-limiting toxicities (DLTs).

The Secondary Objective: To observe the therapeutic efficacy of allogeneic hepatocyte transplantation for liver cirrhosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital

Criteria

Key Inclusion Criteria:

• The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;

• Clinical diagnosis of liver cirrhosis;

• Be able to understand and sign informed consent.

Key Exclusion Criteria:

• Combined with liver cancer or other malignant tumors;

• Patients who can't cooperate;

• Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;

• International normalized ratio (INR) >1.5;

• PLT<60×109/L；

• Recently use of anticoagulant or antiplatelet drugs (last 7 days);

• Recently (last 4 weeks) had upper gastrointestinal bleeding or spontaneous celiac inflammation;

• Moderate or large amount of ascites;

• The investigator assesses that the patient is unable or unwilling to comply with the protocol.