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评估 Cellgram-LC 在酒精性肝硬化患者中的疗效和安全性的临床试验 (Cellgram-LC)

2026年9月16日 更新者：Pharmicell Co., Ltd.

评估 Cellgram-LC 在酒精性肝硬化患者中的疗效和安全性的多中心、随机、开放标签 III 期临床试验

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 韩国
      • Ansan、韩国
        • 招聘中
        • Korea University Ansan Hospital
        • 接触：
      • Bucheon-si、韩国
        • 招聘中
        • Soonchunhyang University Hospital
        • 接触：
      • Cheonan、韩国
        • 终止
        • Soonchunhyang University Hospital
      • Chuncheon、韩国
        • 终止
        • Gangwon National University Hospital
      • Chuncheon、韩国
      • Gangneung-si、韩国
        • 招聘中
        • Gangneung Asan Hospital
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Seoul National University Hospital
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Korea University Anam Hospital
        • 接触：
      • Seoul、韩国
        • 尚未招聘
        • Severance Hospital
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Gangnam Severance Hospital
        • 接触：
          • Hyun-Woong Lee
          • 电话号码：+82-2-2019-3315
          • 邮箱：LHWDOC@yuhs.ac
      • Seoul、韩国
        • 招聘中
        • Soonchunhyang University Hospital
        • 接触：
      • Seoul、韩国
      • Seoul、韩国
        • 招聘中
        • Seoul St. Mary's Hospital
        • 接触：
      • Wŏnju、韩国
        • 招聘中
        • Wonju Severance Christian Hospital
        • 接触：
        • 副研究员：
          • Sun-gu Baek
      • Yŏngin、韩国
        • 招聘中
        • Yongin Severance Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 71年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. At the time of screening, 19 or 70 years
  2. 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)
  3. Those whose survival period is more than 1 year when judged by the tester
  4. Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
  5. 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
  6. Those who can conduct clinical trials according to the clinical trial protocol
  7. A person who has consented in writing to voluntarily participate in this clinical trial

Exclusion Criteria:

  1. 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

  2. Patients who underwent portal systemic shunting in the jugular vein

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

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

  5. Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening

  6. Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening

  7. 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; 1. bleeding predisposition, 2. coagulation, 3. platelet≤50,000/mm3 and INR≥1.5)

  8. serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor

  9. Patients unable to collect bone marrow due to bone marrow disease

  10. Those with a history of gentamicin hypersensitivity reaction

  11. Pregnant or lactating women

  12. Those with substance abuse experience within 1 year before screening

  13. Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)

  14. Those who previously participated in clinical trials related to cell therapy

  15. Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control group

Best supportive care.
其他：Best Supportive Care (BSC)

Participants receive best supportive care.
实验性的：Cellgram-LC

Participants receive a single dose of Cellgram-LC through the hepatic artery.
生物：Cellgram-LC

Participants receive a single injection of 7 × 10^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Transplant free survival (TFS)
大体时间：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.
For 3 years

次要结果测量

结果测量
措施说明
大体时间
Survival rate
大体时间：month 24 and 36

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
大体时间：week -6 and 0

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
大体时间：week -6 and 0

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
大体时间：month 0, 1, 3, 6, 9, 12, 18 and 24

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
大体时间：month 0, 6, 12, 18 and 24

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Ⓡ
大体时间：week -6 and 0

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
大体时间：month -1, 6, 12, 18 and 24

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
大体时间：month -1, 6, 12, 18 and 24

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

其他结果措施

结果测量
措施说明
大体时间
α-fetoprotein test
大体时间：week -6, month 3, 6, 9, 12, 18, 24

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pharmicell Co., Ltd.

调查人员

  • 首席研究员：Moonyoung Kim、Wonju Severance Christian Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月19日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2020年12月21日

首先提交符合 QC 标准的

2020年12月28日

首次发布 (实际的)

2020年12月30日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PMC-P-07

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made available to other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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