NL-OMON45407撤回2 期
Allogeneic mesenchymal Stromal cells for Angiogenesis and neovascularization in no-option Ischemic Limbs - SAIL Trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 18 至 64（—）
入选标准
- •-age >18 years
- •-severe peripheral artery disease (PAD) (Fontaine class III or IV)
- •(Rutherford 4 or 5)
- •-persistent, recurring rest pain requiring analgesia, and/or non-healing
- •ulcers present for >4 weeks without evidence of improvement in
- •response to conventional therapies
- •-ankle brachial index (ABI) <0.6 or non-compressible/ unreliable
- •-not eligible for surgical or endovascular revascularization
- •-written informed consent.
排除标准
- •-history of neoplasm or malignancy in the past 10 years
- •-serious known concomitant disease with life expectancy <1 year
- •-Rutherford 6 in which amputation on the short term (within 1-2 weeks)
- •is inevitable
- •-Pregnancy or unwillingness to use birth control measures such as oral
- •contraceptives or other (hormonal, uterine implant, barrier method)
- •precautions during study
- •-uncontrolled infection with systemic symptoms
- •-follow-up impossible
研究者
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