NL-OMON20190招募中不适用
Efficacy assessment of repeat intramyocardial injection of autologous bone marrow cells in previously responding no-option patients with residual or recurrent refractory angina pectoris and documented ischemia.
eiden University Medical Center (LUMC), Department of Cardiology0 个研究点目标入组 23 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 23
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Having received intramyocardial bone marrow cell injection in study P02.051 (Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Refractory Angina Pectoris and Ischemia, a two-phased study of safety, feasibility and efficacy) or P05.025 (Efficacy assessment of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia, a randomized, double blind, placebo controlled study);
- •2. Disabling refractory angina pectoris despite optimal medical therapy;
排除标准
- •1. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) as bone marrow cell infusion might promote tumor growth through induction of angiogenesis in the tumor;
- •2. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the injection procedure;
研究者
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Efficacy assessment of repeat intramyocardial injection of autologous bone marrow cells in previously responding no-option patients with residual refractory angina pectoris and documented ischemia - Repeat cell therapy for refractory anginaIn coronary artery disease atherosclerosis leads to a decrease in lumen diameter of the large epicardial arteries, causing a deficit in blood flow known as ischemia. This ischemia can cause chest pain, referred to as angina pectoris. Refractory angina pectoris is a disabling condition with an adverse prognosis with a high mortality rate. This severe disorder has a significant morbidity and impact on quality of life. Many patients have very limiting complaints, despite optimal medical therapy.EUCTR2009-017924-18-NL23
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