Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial
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: 12 week mortality rate
研究概览
简要总结
Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be blinded to participant, care provider, investigator and outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years old
- •Meeting the criteria of ACLF defined as:
- •definitive chronic liver diseases, acute decompensation within 4 weeks;
- •Significant GI symptom as such fatigue, jaundice,;
- •total bilirubin (TBIL) ≥170 µmo1/L or daily increase of TBIL ≥17.1 µmo1/L;
- •PTA≤40% or INR≥ 1.5;
- •Decompensation of liver functions such as ascites or hepatoencephalopathy;
- •MELD score between 17-
- •(MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643)
- •Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
- •Informed consent
排除标准
- •Sever complications with 30 days ( GI bleeding, severe infection)；
- •-liver cancer or other malignancies
- •patients on liver transplantation list
- •patients with uncontrolled infections
- •severe renal failure
- •Severe chronic obstructive pulmonary disease COPD (GOLD III-IV)
- •Extrahepatic cholanstasis patients due to biliary obstruction.
- •HIV infection
- •Pregnant or breast-feeding females.
- •Enrolled in other clinical trials with 3 months
- •other conditions considered inappropriate for the study
研究组 & 干预措施
MSC group
mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks
干预措施: mesenchymal stem cell transplantation or placebo infusion via peripheral vein (Procedure)
control
placebo infusions (placebo infusion differs from the experimental infusion in only that placebo has no mesenchymal stem cells) will be administered via peripheral vein at week 0, 1, 2
干预措施: mesenchymal stem cell transplantation or placebo infusion via peripheral vein (Procedure)
结局指标
主要结局
Efficacy: 12 week mortality rate
时间窗: 12 weeks
mortality rate assessed at week 12
次要结局
- Clinical remission rate at week 12(12 weeks)
研究者
Han Ying
Prof. Dr.
Xijing Hospital of Digestive Diseases