Phase III Study Evaluating Safety and Effectiveness of Cellgram-LC Injection for Alcoholic Liver Cirrhosis

What this Trial Is About

Researchers are evaluating the efficacy and safety of autologous Mesenchymal Stem Cells MSC injected into the hepatic artery for patients with alcoholic liver cirrhosis. This phase III clinical trial aims to assess the effects of a single dose of Cellgram-LC on patients with this condition, focusing on outcomes up to 60 months after treatment. The study is sponsored by Pharmicell Co., Ltd. and involves patients diagnosed with alcoholic cirrhosis who meet specific clinical criteria. Participants are randomly assigned to one of two groups one receiving best supportive care without intervention, and the other receiving a single injection of 7x107 autologous bone marrow-derived mesenchymal stem cells Cellgram-LC delivered directly into the liver through the hepatic artery. The injection is performed within one month after bone marrow extraction. This open-label study monitors patients over several years to evaluate long-term outcomes. During the trial, participants undergo various assessments including survival evaluations, liver function tests, fibrosis measurements, and quality of life questionnaires at multiple time points up to 36 months. Researchers monitor transplant-free survival as the primary outcome over three years. Secondary outcomes include changes in liver severity scores, liver enzyme levels, fibrosis indicators, and health status measures. Safety and efficacy are evaluated throughout the study period, which extends up to five years from treatment.

Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis