NCT04689152招募中3 期
A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Transplant free survival (TFS)
研究概览
简要总结
This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.
详细描述
To evaluate the efficacy and efficacy for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Those who can conduct clinical trials according to the clinical trial protocol
- •A person who has consented in writing to voluntarily participate in this clinical trial
排除标准
- •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
- •If you have not been diagnosed with a malignant blood disease (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy)
- •Severe aplastic anemia
- •Liver transplant history
- •Liver diseases of other causes besides alcoholic cirrhosis: hepatitis B and C, autoimmune liver disease (primary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liver disease , NAFLD), Wilson's disease, iron excess, alpha-1-antitrypsin deficiency, etc.)
- •Extrahepatic biliary stenosis
- •Active portal vein or hepatic vein thrombosis
- •Heart failure or respiratory failure
- •Severe renal impairment (when the result of serum creatinine test exceeds 1.5 times the upper limit of normal)
- •Acute or chronic infection requiring systemic treatment
- •Severe coagulation disorder (if the tester judges it as a severe coagulation disorder or one of the following 1 to 3;
- •bleeding predisposition,
- •coagulation,
- •platelet≤50,000/mm3 and INR≥1.5)
- •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
研究组 & 干预措施
Control group
No Intervention
Best Supportive care
结局指标
主要结局
Transplant free survival (TFS)
时间窗: For 3 years
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.
次要结局
- Change amount of Fibrosis-4(month 0, 6, 12, 18 and 24)
- Survival rate(month 24 and 36)
- Change amount of Liver function test(month 0, 1, 3, 6, 9, 12, 18 and 24)
- Change amount of Child-Pugh score(week -6 and 0)
- Change amount of EQ-5D(month -1, 6, 12, 18 and 24)
- Change amount of MELD score(week -6 and 0)
- Change amount of FibroScanⓇ(week -6 and 0)
- Change amount of EQ-VAS(month -1, 6, 12, 18 and 24)
研究者
研究点 (15)
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