Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
Pharmicell Co., Ltd.
200 participants
Apr 19, 2021
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis. The main questions it aims to answer are: * Is Cellgram-LC superior to best supportive care (BSC) in patients with alcoholic cirrhosis? * What medical problems do participants have after receiving Cellgram-LC compared with BSC? Participants will: * Receive a single dose of Cellgram-LC at Week 0 or receive best supportive care according to their assigned study group. * Attend clinic visits for scheduled assessments at Week 4 and Months 3, 6, 9, 12, 18, and 24. * Complete scheduled telephone follow-up at Months 2, 4, 5, 7, 8, 10, 11, 15, 21, 27, 30, 33, and 36. * Be followed for transplant-free survival and other study outcomes.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
Participants receive best supportive care.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT04689152