Stem cells in Heart disease

Conditions: Ischemic heart disease
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-005371-40-PL

Lead Sponsor: Szpital im. Jana Pawla II

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- End stage CHNS
- no possibility PCI or CABG
- Optimal medical therapy
- Symptoms (CCS III or IV)
- viability front and / or side wall of the myocardium
- EF> 30%
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Unstable ischemic heart disease,
- Acute myocardial infarction,
- Valvular heart disease,
- Heart defect congenital or acquired,
- EF <30%,
- Severe arrhythmias,
- Contraindications to general anesthesia,
- Contraindications to cardiac surgery,
- A disease in which life expectancy is less than 2 years,
- Peripheral vascular disease, restrictive normal functioning.,
- allergic for high-osmolar contrast media, claustrophobia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to demonstrate that the administration of stem cells taken from fat in observing the annual improve<br>regional myocardial contractility in patients with end-stage ischemic heart disease disqualified from<br>traditional treatments of myocardial revascularization.;Secondary Objective: Improvement in angina relief;Primary end point(s): Improvement of regional myocardial contractility - changes in fractional shortening of the treated area assessed cardiac MRI;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Improved perfusion of the treated area through increased angiogenesis assessed on the basis of the quality of life, 6-minute walk test, echocardiography and reduce discomfort CCS class;Timepoint(s) of evaluation of this end point: 6 months, 1 year