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.
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
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
Parallel
Cellgram-LC
Biological/VaccineParticipants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
Best Supportive Care (BSC)
Other interventionParticipants receive best supportive care.
Transplant free survival (TFS)
Transplant free survival (TFS), the median survival time and 95% confidence interval for each group were presented using the Kaplan-Meier method, and the difference in the survival distribution between the two groups was used as a Cox proportional hazards model corrected for stratification Black.
Survival rate
For the survival rate, the survival rate and 95% confidence interval at each time point are presented using the Kaplan-Meier method, and the difference in survival rate between the two groups is tested using the Z statistic.
Change amount of Child-Pugh score
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable. CP score was calculated using five factors: hepatic encephalopathy, prothrombin time, bilirubin, serum albumin, and ascites, and the score range was 5-15 points. In the Child-Pugh grade, scores of the five factors are summed and evaluated as A if it is less than 7 points, B if it is 7-9, and C if it exceeds 9 points.
Change amount of MELD score
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable. The higher the score, the higher the mortality rate.
Change amount of Liver function test
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
α-fetoprotein test
Two sample t-test or Wilcoxon rank-sum test is performed to test the difference between the two groups for the results of tumor marker test (AFP) at each time point.
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