Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficacy: Change of liver functions as assessed by MELD score
研究概览
简要总结
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.
This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blind to the randomization results of the participants.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •HBV -related liver cirrhosis
- •Child-Pugh score ≥7
- •With presentations of decompensation
- •Written consent
排除标准
- •Hepatocellular carcinoma or other malignancies
- •Severe problems in other vital organs(e.g.the heart,renal or lungs)
- •Pregnant or lactating women
- •Severe bacteria infection
- •Anticipated with difficulty of follow-up observation
- •Coinfection with HIV or other viral hepatitis.
- •Drug abuse or alcohol abuse
- •History of severe allergy to biological products
- •Other candidates who are judged to be not applicable to this study by doctors -
研究组 & 干预措施
control
Standard medication for viral hepatitis and cirrhosis
MSC group
mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.
干预措施: mesenchymal stem cell transplantation via peripheral vein (Procedure)
MSC group
mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.
干预措施: mesenchymal stem cell (Other)
结局指标
主要结局
Efficacy: Change of liver functions as assessed by MELD score
时间窗: 1 year
Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43)
Safety: Adverse events as assessed according to CTCAE 4.03
时间窗: 1 year
Adverse events as assessed according to CTCAE 4.03
次要结局
- Histological change of the liver: Histological scores assessed by liver biopsy(1 year, 2 year and 5 years)
- Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy(1, 2 and 5 years)
- Survival Benefit: Survival Rate at different time points(1 year, 2 year and 5 years)
研究者
Han Ying
Consultant Physician, Professor
Xijing Hospital of Digestive Diseases