EUCTR2011-005435-98-PL
Active, not recruiting
Phase 1
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 sitesFebruary 24, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stable angina pectoris CCS II-IV
- Sponsor
- Slaski Uniwersytet Medyczny w Katowicach
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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