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Clinical Trials/EUCTR2011-005435-98-PL
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.

Registry
who.int
Start Date
February 24, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Slaski Uniwersytet Medyczny w Katowicach

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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