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
干预措施
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
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.
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
盲法说明
This is an open-label study in which investigators and participants are aware of the assigned treatment.
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
Active Comparator
Best supportive care.
干预措施: Best Supportive Care (BSC) (Other)
Cellgram-LC
Experimental
Participants receive a single dose of Cellgram-LC through the hepatic artery.
干预措施: Cellgram-LC (Biological)
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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