Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Survival rate on day 28 after treatment
研究概览
简要总结
The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 65 years old;
- •Patients with acute liver failure in the early and intermediate stages caused by various reasons;
- •Total bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
- •Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);
- •No hepatic encephalopathy or encephalopathy below grade II (including grade II);
- •Elevated inflammatory markers (IL-6 / TNF-α / CRP, etc.);
- •The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;
- •The subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment.
排除标准
- •Patients with severe active bleeding or diffuse intravascular coagulation;
- •Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
- •Patients with circulatory failure;
- •Patients with a MELD score > 30;
- •Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;
- •Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
研究组 & 干预措施
Blood purification with mesenchymal stem cells therapy group
干预措施: It is loaded with a mesenchymal stem cells reaction device for blood purification (Device)
结局指标
主要结局
Survival rate on day 28 after treatment
时间窗: From enrollment to day 28 after treatment.
researchers record all participators' survival condition from enrollment to day 28 after treatment.
次要结局
- conversion rate to liver transplantation(From enrollment to day 28, 56, 84 after treatment.)
- Interleukin-6(IL-6)(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- Survival rate on day 7, 14, 56, 84 after treatment(From enrollment to day 7, 14, 56, 84 after treatment.)
- lactic aicd(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- Model for End-Stage Liver Disease score(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- Chinese group on the study of severe hepatitis B-acute-on-chronic liver failure score(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- tumor necrosis factor α (TNF-α)(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- C-reactive protein (CRP)(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- blood ammonia(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- Alpha-fetoprotein (AFP)(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- ferritin(From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.)
- Incidence rate of adverse events (AE incidence rate)(Throughout the entire course of MSC-based blood purification therapy.)
研究者
Kebo Zhong
doctor
Zhujiang Hospital