The Evaluation of Effectiveness and Safety for New Therapy With Bone Marrow Derived Autologous Mesenchymal Stem Cell for Hepatic Failure Caused by Alcoholic Liver Cirrhosis
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The improvement of Liver Histologic grade
研究概览
简要总结
Background & Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study was done in humans with alcoholic liver cirrhosis. The researchers investigated the anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.
Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in patients' histology Aim :
The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver cirrhosis.
详细描述
Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcoholic liver cirrhosis(child Pugh class B or C, ≥ 7 scores),confirmed by clinically or biopsy.
- •Stop drinking over past 6months.
- •Patients agree with informed consent Patients must satisfy all inclusion criteria.
排除标准
- •Patients who did not satisfy inclusion criteria
- •Hepatocellular carcinoma
- •Pregnancy or breast feeding
- •Infective disease(HIV, HBV, HCV..)
- •Other incurable malignancy
研究组 & 干预措施
MSC injection
This study is designed as single interventional arm without comparative arm. MSC injection means hepatic artery catheterizations and mesenchymal stem cell injection through catheter.
干预措施: mesenchymal stem cell injection (Biological)
结局指标
主要结局
The improvement of Liver Histologic grade
时间窗: 6 months later
according to Metavir and Laennec fibrosis scoring system
次要结局
- The evaluation of hepatic dendritic cells activity by immunohistochemistry(baseline and 6 months later)
- Liver stiffness measurement with transient elastography(baseline and 6 months later)
- Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue(baseline and 6 months later)
- Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9(baseline and 6 months later)
- Hepatic venous pressure gradient(HVPG)(baseline and 6 months later)
- Hepatic vein arrival time using microbubble contrast enhanced ultrasonography(baseline and 6 months later)
- Child-Pugh score(baseline and 6 months later)
- MELD score(baseline and 6 months later)
研究者
Moon Young Kim
Associate Professor
Yonsei University