NCT01499459Unknown不适用
Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- clinical improvement
研究概览
简要总结
This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiological, clinical and histopathological diagnosis of liver cirrhosis
- •absence of hepatocellular carcinoma or any malignancies
- •no psychiatric disorder
- •no serous cardiovascular and pulmonary comorbidities
- •serum total bilirubin levels less than 5 mg/dL
- •platelet counts more than 30.000 mm3
- •more than one year follow up period after initiation of antiviral drugs
排除标准
- •alcohol intake in last one year
- •initiation of antiviral medication in last one year
- •systemic diseases
结局指标
主要结局
clinical improvement
时间窗: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation
biochemical and hematologic parameters
次要结局
- liver regeneration(6.th month after MSC transplantation)
研究者
Murat Kantarcioglu
Gulhane Military Medical Academy
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
研究点 (2)
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