Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Liver function worsening
研究概览
简要总结
This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.
Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.
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
- •Chronic virus C hepatitis
- •Liver cirrhosis
- •Moderate liver disfunction
排除标准
- •Malignant disease
- •Pregnancy
- •Significant comorbidity
- •Portal vein thrombosis
结局指标
主要结局
Liver function worsening
时间窗: One year
次要结局
- Liver related mortality(One year)
- Hepatocellular carcinoma development accessed by ultrasound and CT scan(One year)
- BMMC kinetics accessed by total body scintigraphy(24 hours)
- Liver tissue changes evaluated by histopathology analysis and molecular biology(10 weeks)