Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults
Acute-On-Chronic Liver Failure, Chronic Liver Failure
About this trial
This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring Acute-On-Chronic Liver Failure, Chronic Liver Failure, cell transplantation, hepatocyte transplantation, micro-encapsulate
Eligibility Criteria
Inclusion Criteria: A. Chronic liver failure (CLF) group: The progressive liver function decline or decompensation after liver cirrhosis: Body weight>40kg; Aged between 18 to 65 years old; Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN); With or without significantly decreased serum albumin value, lower than 35; With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded; With or without refractory ascites or portal hypertension; With or without a stage I or II hepatic encephalopathy; 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). Body weight>40kg; Aged between 18 to 65 years old; With obvious fatigue, accompanied by other gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension; Complicated with ascites and/or hepatic encephalopathy within 4 weeks after being diagnosed; Progressive aggravation of jaundice, total serum bilirubin≥85umol/L; Coagulation disorders, INR>1.5 or PTA<40%; No obvious improvement after more than 3 days' regular clinical treatments. Exclusion Criteria: With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage; Diagnosed or suspected as primary or metastatic liver cancer; With uncorrectable oxygenation index (PaO2/FiO2)<200; With disseminated intravascular coagulation; Active hemorrhage; Uncontrollable infection, including ascites infection such as spontaneous bacterial peritonitis; Uncorrectable decrease in PLT (<20×109/L); HIV and/or SARS-CoV-Ⅱ positive; Drug abuse within 1 year; Systemic hemodynamic instability; Combined with pregnancy or lactation; Other situations excluded by clinician;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 1
Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 2
Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 3
Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 4
Participants will each be administered the dosage of 0.15×10^9 for one time, with 60 days follow-up after the cell infusion.
Participants will each be administered the dosage of 0.5×10^9 for one time, with 60 days follow-up after the cell infusion.
Participants will each be administered the dosage of 1.5×10^9 for one time, with 60 days follow-up after the cell infusion.
Participants will each be administered the dosage of 4.5×10^9 for one time, with 60 days follow-up after the cell infusion.