Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- BUN
研究概览
简要总结
In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney failure. The potential for stem cells to treat kidney failure was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function and alleviating renal injury in these patients. Therefore, the investigators propose a hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis patients, particularly reducing the decompensated conditions in these patients.
详细描述
Kidney fibrosis represents the common pathway to end-stage kidney failure.The potential for stem cells to treat kidney failure was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, kidyney injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs (MSC) can improve the disease conditions in patients with kidney fibrosis. This study will also look at safety in these patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Glomerular sclerosis ratio ≤ 50%.
- •Renal tubulointerstitial fibrosis ratio ≤ 50%.
- •Negative pregnancy test.
- •Moderately active disease under standard treatment.
排除标准
- •Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
研究组 & 干预措施
Conventional plus MSC treatment
干预措施: MSC (Biological)
结局指标
主要结局
BUN
时间窗: 24 months
The evaluation of serum levels of BUN
Cr
时间窗: 24 months
The evaluation of serum levels of Cr
eGFR
时间窗: 24 months
The evaluation of serum levels of eGFR
Cystatin C
时间窗: 24 months
The evaluation of serum levels of Cystatin C
Urine protein
时间窗: 24 months
The evaluation of serum levels of Urine protein
次要结局
- Hb(24 months)
- Hct(24 months)
- Ca(24 months)
- P(24 months)
- ALT(24 months)
- PTH(24 months)
- VitD(24 months)
- ALB(24 months)
- TC(24 months)
- TG(24 months)
研究者
Ling Lu
Principal Investigator
Nanjing Medical University