Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 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 kidney disease (CKD).
详细描述
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) 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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •CKD symptoms
- •CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
- •Patient's age between 25 - 60 years
- •Ability to understand and willingness to sign consent from
排除标准
- •Pregnant or lactating
- •Basis disease such as diabetes, malignancy and autoimmune
- •Unable to follow post-operative exercise regimen or return for evaluations
结局指标
主要结局
mass formation
时间窗: 6months
Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
Creatinin
时间窗: 1 month
Evaluation the rise of creatinin 1 month after cell transplantation.
次要结局
- GFR(6months)