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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-71
SponsorPharmicell Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

At the time of screening, 19 or 70 years

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)

Those whose survival period is more than 1 year when judged by the tester

Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner

Disqualifiers

Those with a history of solid cancer including Hepatocellular Carcinoma (HCC) (within 5 years before screening), those who have been diagnosed with solid cancer and are currently undergoing chemotherapy or those whose hepatocellular carcinoma has been confirmed by screening tests

Patients who underwent portal systemic shunting in the jugular vein

Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening

Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening

Trial design

Treatments tested in this trial

  • Cellgram-LC

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators