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This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.
To evaluate the efficacy and efficacy for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Best Supportive care | |
| Injection group: Cellgram-LC | Experimental | Within 1 month after extracting bone marrow, directly inject 7X10^7 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellgram-LC | Biological | Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | month 24 and 36 |
| Change amount of Child-Pugh score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week -6, month 3, 6, 9, 12, 18, 24 |
Inclusion Criteria:
Exclusion Criteria:
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
Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
Those whose medical history or accompanying diseases following the screening time is confirmed
serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
Patients unable to collect bone marrow due to bone marrow disease
Those with a history of gentamicin hypersensitivity reaction
Pregnant or lactating women
Those with substance abuse experience within 1 year before screening
Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)
Those who previously participated in clinical trials related to cell therapy
Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIYEOUN JEONG | Contact | 82-2-3496-0134 | jyjeong@pharmicell.com |
| Name | Affiliation | Role |
|---|---|---|
| Moonyoung Kim | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital | Recruiting | Bucheon-si | South Korea |
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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. |
| week -6 and 0 |
| 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. | week -6 and 0 |
| 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. | month 0, 1, 3, 6, 9, 12, 18 and 24 |
| Change amount of Fibrosis-4 | 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. | month 0, 6, 12, 18 and 24 |
| Change amount of FibroScanⓇ | 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. | week -6 and 0 |
| Change amount of EQ-5D | 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 quality of life. | month -1, 6, 12, 18 and 24 |
| Change amount of EQ-VAS | 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 quality of life. | month -1, 6, 12, 18 and 24 |
| Soonchunhyang University Hospital | Recruiting | Cheonan | South Korea |
|
| Gangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Hallym Univ. Medical Center | Recruiting | Chuncheon | South Korea |
|
| Gangneung Asan Hospital | Recruiting | Gangneung-si | South Korea |
|
| Eunpyeong St. Mary's Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Soonchunhyang University Hospital | Recruiting | Seoul | South Korea |
|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
|
| ID | Term |
|---|---|
| D008104 | Liver Cirrhosis, Alcoholic |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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