Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with End-stage Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Proportion of patients with Child A
研究概览
简要总结
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.
详细描述
Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •End-stage liver disease
- •Signed informed consent
排除标准
- •Tumours of the liver or other organs
- •Liver transplantation recipients
- •Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
- •Other diseases that may seriously affect the survival
- •Human immunodeficiency syndrome
- •Interferon or glucocorticoid therapy within 1 year
- •Treated for mental illness
- •Participation in other clinical trials within 30 days
- •Pregnant or breastfeeding subjects
- •Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
- •Other circumstances that are unsuitable for participation in this study
研究组 & 干预措施
Single-infusion group
Single peripheral venous infusion of stem cells
干预措施: umbilical cord-mesenchymal stem cells (Biological)
Double-infusion group
Repeated peripheral venous infusion of stem cells within one month
干预措施: umbilical cord-mesenchymal stem cells (Biological)
结局指标
主要结局
Proportion of patients with Child A
时间窗: 24 weeks
Patients with Child A
次要结局
- Change in liver function parameters(24 weeks)
- Incidence of hepatic decompensation events(24 weeks)
- Survival rate and liver transplant rate(24 weeks)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region