Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Angiographic evaluation of angiogenesis and vasculogenesis at target limb
研究概览
简要总结
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
详细描述
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.
After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes.
Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of:
- Changes in below-the-knee angiography from baseline to 3 months follow-up.
- Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients under treatment (type I or II)
- •Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index < 0,8)
- •Not suitable to be revascularized (surgical and interventional consensus)
排除标准
- •Neoplastic disease and/or hematologic disease during the last 2 years
- •Diabetic retinopathy
- •Ischemic ulcer greater than 10 cm2
- •Major amputation at target limb
- •Life expectancy > 2 years
结局指标
主要结局
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
时间窗: 3 months
次要结局
- Ankle-Brachial pressure index(3 months)