Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- UACR
研究概览
简要总结
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.
详细描述
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(in brief):
- •Type 2 diabetes mellitus
- •Diabetes duration≤20 years
- •18.5kg/m^2 ≤ BMI< 30 kg/m^2
- •7.5%≤HbA1C≤10%
- •UACR≥30mg/gCr
- •eGFR ≥45/milliliter/1.73m^2
排除标准
- •(in brief):
- •Type 1 diabetes mellitus
- •tumor history
- •Other causes of chronic kidney disease
- •Abnormal liver function
结局指标
主要结局
UACR
时间窗: 48weeks after treatment
urinary albumin creatinine ratio
次要结局
- HbA1c(48weeks after treatment)
- eGFR(48weeks after treatment)
- insulin/C peptide(48weeks after treatment)
- insulin dosage(48weeks after treatment)