Mesenchymal stem cell therapy in patients with severe myocardial ischemia - Stem celle therapy in ischemic heart disease
Phase 1
- Conditions
- Chronic coronary artery disease
- Registration Number
- EUCTR2005-002657-45-DK
- Lead Sponsor
- Cardiovascular laboratory 2014, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Age between 30 and 80 years
Modrate to severe angina pectoris CCC class > II
Reversible ischemia on SPECT
Reduced exercise capacity due to angina
No further revascularization options
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnant women
Abnormal blood tests
Reduced kidney function (serum Creatinine > 1,7 mg/dl)
Proliferativ retinopati
Left ventricle ejektions fraction < 25%
NYHA-klasse III-IV
Valvular heart disease
Malignant disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To induce vasculogenesis and improve blood flow in ischemic myocardium by treatment with autologous mesenchymal stem cells.;Secondary Objective: ;Primary end point(s): Improvement in myocardial blood flow by SPECT
- Secondary Outcome Measures
Name Time Method