CTRI/2010/091/000565已完成1 期
Induction of therapeutic Angiogenesis in Limb Ischemia by Intra-arterial delivery of Autologous bone marrow derived stem cells
Department of Biotechnology New Delhi0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)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.
- •2) 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
研究者
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