Phase 2a Study of Safety and Effectiveness of Hepatocyte Transplantation into Lymph Nodes for Adults with End-Stage Liver Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of transplanting hepatocytes into lymph nodes for people with end-stage liver disease ESLD. This Phase 2a open-label dose escalation study aims to find the right dose and assess how well the transplanted cells engraft in subjects with ESLD caused by various liver conditions. The study includes up to 12 participants and is sponsored by LyGenesis, Inc. Participants receive allogenic hepatocytes suspended in a preservation solution, which are transplanted into periduodenal lymph nodes using endoscopic ultrasound. The study uses a dose-escalation approach, gradually increasing the number of lymph nodes treated. Subjects also receive immune-suppressing medications including tacrolimus capsules and a short course of prednisone to support the transplant. During the study, participants are monitored closely for safety and how well the hepatocytes engraft at 12 weeks, along with liver function tests assessed up to 52 weeks. Researchers evaluate dosage selection, safety, and efficacy at week 12, and the treatments effect on liver function over one year. Participants must comply with study requirements and avoid alcohol during the trial, which lasts over a year including follow-up visits and assessments.

Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes