Micro-encapsulated Hepatocytes Intraperitoneal Transplantation Therapy for Adult Liver Failure: A Phase I Dose Escalation Safety and Tolerability Study

What this Trial Is About

Researchers are evaluating the safety and maximum tolerated dose of microencapsulated hepatocyte therapy in adults with liver failure, including chronic liver failure and acute-on-chronic liver failure. The study aims to explore the use of engineered encapsulated liver organoids derived from proliferating human hepatocytes as a new treatment option. This phase 1 dose escalation study seeks to determine the appropriate dosage and preliminary effectiveness of this therapy. Participants receive a single intraperitoneal transplantation of microencapsulated hepatocytes at escalating doses, ranging from 0.15 billion to 4.5 billion cells. The trial uses an accelerated titration design followed by a 3+3 design to carefully increase dosage while minimizing exposure to ineffective doses. After receiving the treatment, participants are monitored closely over 60 days for safety and clinical response. Regular clinical treatments, including liver transplantation if needed, remain available throughout the study. During the study, participants undergo safety assessments and efficacy evaluations at multiple time points: days 1, 3, 7, 14, 28, and 60 after treatment. Researchers measure adverse events, maximum tolerated dose, liver function scores, survival rates compared to historical controls, antibody formation against the transplant cells, and clinical improvements. This comprehensive monitoring ensures detailed data collection on treatment effects and participant well-being throughout the follow-up period.

Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults