CTRI/2010/091/000565已完成1/2 期
Induction of therapeutic Angiogenesis in Limb Ischemia by Intra-arterial delivery of Autologous bone marrow derived stem cells
Department of Biotechnology New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年1月15日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in the composite of clinical status and improvement in TcO2 and improvement in ABI
研究概览
简要总结
This is randomised controlled clinical trial to evaluate the feasibility, safety and therapeutic efficacy of angiogenesis induced by intra-arterial delivery of stem cells derived from autologous bone marrow in patients with critical limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical a)Rest pain requiring analgesia for > 2 weeks, and/or non healing ischemic ulcers b)Absent /weak peripheral pulses c)No response to smoking cessation for at least 3 months prior to evaluation d)Not suited for surgical/ endovascular revascularization d)Unilateral or bilateral involvement e) Claudication distance of <200 meters.
- •Hemodynamic a) Doppler study showing an occluded superficial femoral, popliteal, or infra-popliteal artery, with no or poor distal flow as evidenced by a monophasic, low velocity, collateralized flow pattern.
- •b) Contrast-enhanced magnetic resonance and digital subtraction angiography demonstrating the site of occlusion, status of distal run-off and the extent of collateralization c) Ankle systolic pressure < 50 mm Hg d) A resting ankle brachial pressure index <0.5 in the affected limb on 2 consecutive examinations done at least 2 days apart (normal range, 0.9-1.1).
排除标准
- •a)Poorly controlled diabetes mellitus b)Evidence of a malignancy during the last 5 year c)Renal dysfunction or other contraindication to injection of contrast media d)Continued smoking e)Limitation to exercise due to any reason other than claudication.
结局指标
主要结局
Changes in the composite of clinical status and improvement in TcO2 and improvement in ABI
时间窗: 1, 3 and 6 month
次要结局
- Improvement in the grade of collaterals or Improvement in the visualization of distal run-off vessels(1, 3 and 6 month)
研究者
研究点 (1)
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