ISRCTN58194927已完成不适用
Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischaemia
eiden University Medical Centre (LUMC) (The Netherlands)0 个研究点目标入组 40 人开始时间: 2006年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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. Severe refractory angina despite optimal medical therapy
- •2. Reversible ischaemia on gated-single photon emission computed tomography (SPECT)
- •3. Not a candidate for (repeat) revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI])
- •4. Male or female, greater than 18 years old
- •5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure)
- •6. Written informed consent
排除标准
- •1. Acute myocardial infarction, PCI or CABG within 6 months of enrolment in the study
- •2. History of malignancy (except low grade and fully resolved non-melanoma skin malignancy)
- •3. Unexplained haematological or biochemical abnormalities
- •4. Concurrent participation in a study using an experimental drug or an experimental procedure within 6 months before the injection procedure
- •5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure)
- •6. Bleeding diathesis or human immunodeficiency virus (HIV) infection
- •7. Inability to follow the protocol and comply with follow-up requirements
研究者
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