Phase 2 Trial of Human Umbilical Cord Mesenchymal Stem Cells to Treat Decompensated Cirrhosis in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells MSCs therapy for patients with decompensated cirrhosis, a serious liver condition with a high death rate. Liver transplantation remains the most effective treatment, but challenges like limited donor availability, high costs, and rejection restrict its use. Given these issues, this study aims to explore MSCs as a potential alternative therapy through a phase 2, multicenter, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either three intravenous doses of MSCs or a placebo at days 1, 8, and 15, alongside standard care. The trial will include 140 patients with decompensated cirrhosis, split evenly between the MSC treatment group and the placebo group. The study treatments are given through IV transfusions, and the trial will be conducted at multiple centers to assess both safety and treatment effects. During the trial, patients will undergo regular assessments including laboratory tests, clinical evaluations, and quality-of-life questionnaires over a period of up to 24 months. The main outcome measured is the change in the Model for End-Stage Liver Disease MELD score from baseline to day 28. Secondary outcomes include longer-term changes in MELD scores, incidence of complications, liver transplant-free survival, liver function tests, and monitoring of treatment-emergent adverse events. This comprehensive monitoring will help determine the potential benefits and risks of MSC therapy for this condition.

Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)