ISRCTN76049483已完成不适用
Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischaemia
eiden University Medical Centre (LUMC) (The Netherlands)0 个研究点目标入组 25 人开始时间: 2007年7月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
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
- 性别
- All
入选标准
- •1. Disabling claudication (Fontaine?s stages IIb/III or Rutherford?s categories 3/4) or critical limb ischaemia (Fontaine?s stages IV or Rutherford?s categories 5/6) despite greater than six months optimal medical therapy
- •2. Ineligibility for angioplasty or bypass procedures
- •3. Male of female, greater than 18 years old
- •4. Life expectancy greater than one year
- •5. Written informed consent
排除标准
- •1. Candidates for angioplasty or bypass procedures
- •2. Inability to undergo bone marrow harvesting
- •3. Life threatening co-morbidity
- •4. International Normalised Ratio (INR) greater than 2
- •5. History of malignant disease in five years prior to treatment
- •6. Inability to undergo arterial catheterisation
- •7. Inability to follow the protocol and to comply with the follow up requirements
- •8. Any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated
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