EUCTR2011-005435-98-PL
进行中（未招募）
1 期
A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study. - REGENT VSE
Slaski Uniwersytet Medyczny w Katowicach0 个研究点2012年2月24日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Stable angina pectoris CCS II-IV
- 发起方
- Slaski Uniwersytet Medyczny w Katowicach
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Stable angina CCS II\-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
- •2\.Presence of \= 1 miocardium segment with ischemia features in Tc\-99m SPECT
- •3\.Patients disqualified from revascularization procedures by heart\-team
- •4\.Patient age \> 18 and \< 75 year old
- •5\.Patient must provide written informed consent for participation in study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 30
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •1\.acute coronary syndrome in less than 6 months prior to enrollment
- •2\.heart failure NYHA III\-IV
- •3\.LVEF\<35%
- •4\.presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
- •5\.status after cardioverter defibrillator or cardiac stimulator implantation
- •6\.allergy to contrast agents
- •7\.malignancy in medical interview
- •8\.HIV, HBV, HCV infection
- •9\.status associated with life expectancy less than 6 months
- •10\.bleeding diathesis
结局指标
主要结局
未指定
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