NCT05106972招募中不适用
A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ishak Inflammation Rating System
研究概览
简要总结
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
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
- •Aged between 20 and 60 (male or female)
- •Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
- •Not suitable for liver transplantation or there is no donor liver source
- •No serious bleeding tendency or active bleeding
- •No hepatic encephalopathy
- •After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score
- •Subjects voluntarily participate in this study and sign informed consent
排除标准
- •Be less than 20 years old or more than 60 years old
- •Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
- •Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
- •Patients with hypersplenism who need splenectomy
- •History of tumors in other organs
- •PT prolongation is greater than 3 seconds
- •Use of human serum albumin within 3 weeks prior to clinical registration
- •Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
- •Spontaneous peritonitis
- •Active infection (viral or bacterial)
- •Pregnant or lactating women
- •The researcher considers it inappropriate to participate in this study
研究组 & 干预措施
UC-MSC infusion
Experimental
UC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks)
干预措施: UC-MSC infusion (Drug)
结局指标
主要结局
Ishak Inflammation Rating System
时间窗: Changes from baseline to 72 weeks
Number of Participants with abnormal Total bilirubin
时间窗: Changes from baseline to 72 weeks
Number of Participants with abnormal albumin
时间窗: Changes from baseline to 72 weeks
Ishak Fibrosis Score
时间窗: Changes from baseline to 72 weeks
次要结局
- Number of Participants with abnormal immunoglobulin(Changes from baseline to 72 weeks)
- portal vein width(Changes from baseline to 72 weeks)
- abdominal volume(Changes from baseline to 72 weeks)
- Number of Participants with abnormal coagulation function(Changes from baseline to 72 weeks)
- Overall survival (OS)(Changes from baseline to 72 weeks)
- HBV-DNA(Changes from baseline to 72 weeks)
- incidence of liver cancer(Changes from baseline to 72 weeks)
- portal vein flow rate(Changes from baseline to 72 weeks)
研究者
研究点 (1)
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