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ID05093881

Long-term Safety Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC

Led by Pharmicell Co., Ltd. · Updated on 2024-03-21

100

Participants Needed

11

Research Sites

83 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received the treatment in the PMC-P-07 clinical trial. The study focuses on monitoring safety outcomes over a 60-month period following a single dose of Cellgram-LC to understand its effects over time. Participants include those with alcoholic liver cirrhosis who had been administered Cellgram-LC in the earlier PMC-P-07 study. This follow-up study does not involve new treatments but observes the long-term safety of the previously given Cellgram-LC dose. During the 5-year follow-up, researchers will assess the rate of adverse events of special interest and the rate of liver transplants among participants. The study involves regular monitoring for up to 60 months to gather safety data and observe participants health outcomes related to their previous Cellgram-LC treatment.

CONDITIONS

Brief Title

Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

Research Team

J

JIYEOUN JEONG

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