Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
研究概览
简要总结
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.
The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.
In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes, type 1 or 2
- •Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
- •No options for target limb revascularization.
排除标准
- •Cancer antecedent in the last two years
- •Current limb infection or limb gangrene
研究组 & 干预措施
Mesenchymal stem cells 0,5 million * weight (kg)
Group of low dose of Mesenchymal stem cells.
干预措施: Autologous adipose derived mesenchymal stem cells (Drug)
Mesenchymal stem cells 1 million * weight (kg)
Group of mid dose of mesenchymal stem cells
干预措施: Autologous adipose derived mesenchymal stem cells (Drug)
结局指标
主要结局
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
时间窗: 6 months
Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Major adverse event (death, target limb amputation)
时间窗: 1 month, 6 months, 12 months
次要结局
- Ankle Brachial Index(1 month, 6 months, 12 months)
- University of Texas Classification at target limb(1 month, 6 months, 12 months)