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Recruiting Phase 3 NCT04689152

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

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Trial Parameters

Condition Alcoholic Cirrhosis
Sponsor Pharmicell Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 200
Sex ALL
Min Age 20 Years
Max Age 71 Years
Start Date 2021-03-02
Completion 2027-08-02
Interventions
Cellgram-LC

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Brief Summary

This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.

Eligibility Criteria

Inclusion Criteria: 1. At the time of screening, 19 or 70 years 2. Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging and pathological examination results, and clinical symptoms at screening, and belonging to Child-Pugh grade B or C (Child-Pugh score of 7 or more) 3. Those whose survival period is more than 1 year when judged by the tester 4. Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner 5. In the case of women of childbearing potential, a person who was confirmed negative in the pregnancy test at screening and agreed to use contraception\* by the method permitted for this clinical trial during the clinical trial 6. Those who can conduct clinical trials according to the clinical trial protocol 7. A person who has consented in writing to voluntarily participate in this clinical trial Exclusion Criteria: 1. Those with a history of solid cancer including Hepatocellular Car

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