Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults
Trial Parameters
Brief Summary
This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease. We previously generated proliferating human hepatocytes (ProliHH) through dedifferentiation of PHH and engineered them into encapsulated liver organoids (eLO), providing an unlimited cell source for hepatocyte transplantation.
Eligibility Criteria
Inclusion Criteria: A. Chronic liver failure (CLF) group: The progressive liver function decline or decompensation after liver cirrhosis: 1. Body weight\>40kg; 2. Aged between 18 to 65 years old; 3. Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN); 4. With or without significantly decreased serum albumin value, lower than 35; 5. With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded; 6. With or without refractory ascites or portal hypertension; 7. With or without a stage I or II hepatic encephalopathy; 8. No obvious improvement after more than 3 days' regular clinical treatments. OR B. Acute-on-chronic liver failure (ACLF) group: With known or unknown basic liver diseases, subjects undergoing acute liver failure syndrome (clinical manifestations indicated as an early stage liver failure). 1. Body weight\>40kg; 2.