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 个研究点开始时间: 2012年2月24日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•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
•F.1.3.1 Number of subjects for this age range 30

•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
•11.renal insufficiency (GFR < 30 mL/min/1.73m2)
•12.pregnancy, lactation, or lack of effective contraception in women of childbearing age

发起方

Slaski Uniwersytet Medyczny w Katowicach