NCT02166489已完成1 期
Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass formation
研究概览
简要总结
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).
详细描述
The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •ADPKD symptoms
- •ADPKD confirmed with sonography and genetic testing
- •Patient's age between 18 - 60 years
- •GFR GFR 25-60 mL/min/1.73 m2
- •Ability to understand and willingness to sign consent from
排除标准
- •Pregnancy or breastfeeding
- •Associated Cardiovascular disease
- •Diabetes requiring medical intervention
- •Other systemic diseases involving the kidneys, such as cancer, autoimmune diseases, blood diseases, liver disease, etc.
- •Hospitalization due to illness in the last two months
- •Life expectancy of less than two years
- •Any allergies to the ingredients used in the cell culture
结局指标
主要结局
Mass formation
时间窗: 1 month
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
次要结局
- Glomerular Filtration Rate (GFR)(6 months)
研究者
研究点 (1)
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