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临床试验/CTRI/2010/091/000565
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

发起方
Department of Biotechnology New Delhi

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