Pilot Clinical Trial (Phase I/II) to Evaluate Safety and Therapeutic Effects of the Administration of Autologous Bone Marrow-derived EPCs in Patients With Advanced Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and tolerability
研究概览
简要总结
Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and peripheral blood cells. EPCs are recruited into injured tissues and play an important role in regeneration and reparation. Experimental and clinical data suggest that EPCs have hepatoprotective activity and could improve liver regeneration during acute and chronic liver injury. The aim of this project is to evaluate the safety and therapeutic effects of autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients with advanced liver 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis (Child-Pugh 8 or above).
- •Ability to sign informed consent
排除标准
- •Age <18 or >75
- •Variceal bleeding or severe infection within the past 30 days before screening
- •Chronic encephalopathy preventing the ability to sign informed consent (it could be done by legal representant of the patient) and/or the ability to follow the study protocol
- •Hepatocellular carcinoma (previous or current)
- •Any current or previous malignancy (within 5 years before the inclusion) except "in situ" tumors or skin basal cell carcinomas
- •Any severe extrahepatic disease during the past 30 days before the inclusion
- •Any current decompensated chronic disease
- •Any contraindication for the examinations of the clinical protocol (medullar aspiration, arteriography, HVPG measurement)
- •Any other condition that could negatively affect the compliance with the protocol
- •Pregnant or breast-feeding women
- •Participation in a trial of an experimental drug or device within 30 days before screening
研究组 & 干预措施
Endothelial Progenitors Cells
Autologous bone marrow-derived endothelial progenitor cells
干预措施: Autologous bone marrow-derived endothelial progenitor cells (Other)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and tolerability
时间窗: 12 months
The safety of the administration of autologous bone marrow-derived EPC in patients with advanced cirrhosis will be evaluated by anamnesis, physical examination, hematological and biochemical variables and imaging examination.
次要结局
- Effect on complications of liver cirrhosis(12 months)
- Effect on portal hypertension(12 months)
- Changes of liver function test as a measure of the effect on liver function(12 months)