E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of the study is to demonstrate that the administration of stem cells taken from fat in observing the annual improve regional myocardial contractility in patients with end-stage ischemic heart disease disqualified from traditional treatments of myocardial revascularization. |
Celem badania będzie wykazanie, iż podanie komórek macierzystych z pobranych z tkanki tłuszczowej w obserwacji rocznej poprawi regionalną kurczliwość mięśnia sercowego u chorych z krańcową postacia choroby niedokrwiennej serca zdyskwalifikowanych od tradycyjnych zabiegów rewaskularyzacji mięśnia sercowego. |
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E.2.2 | Secondary objectives of the trial |
Improvement in angina relief |
Zmniejszenie dolegliwosci wiencowych |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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% |
- krańcowa postać CHNS - brak możliwości PCI lub CABG - optymalna terapia medyczna - dolegliwości stenokardialne (CCS III lub IV) - żywotność przedniej i/lub bocznej ściany mięśnia sercowego - EF>30%
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E.4 | Principal 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 |
- niestabilna choroba niedokrwienna serca, - świeży zawał mięśnia sercowego, - wada zastawkowa, - wada serca wrodzona lub nabyta, - EF<30%, - ciężkie zaburzenia rytmu, - przeciwwskazania do znieczulenia ogólnego, - przeciwwskazania do operacji kardiochirurgicznej, - choroby w których oczekiwana długość życia jest poniżej 2 lat, - choroby naczyń obwodowych, ograniczające normalne funkcjonowanie., - uczelenie na kontrat, klaustrofobia
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of regional myocardial contractility - changes in fractional shortening of the treated area assessed cardiac MRI |
Poprawa regionalnej kurczliwość mięśnia sercowego - zmiany frakcji skracania leczonego obszaru serca oceniana w MRI |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
Poprawa perfuzji leczonego obszaru poprzez zwiększenie neoangiogenezy oceniana na podstawie poprawy jakości życia, 6-minutowego testu marszu, badania echokardiograficznego oraz zmniejszenia dolegliwości klasy CCS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months, 1 year |
6 miesiecy, 1 rok |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluate the use of stem cells in the ischemic area of the heart muscle |
Ocena zastosowania komorek macierzystych w niedokrwionym obszarze miesnia sercowego |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Pozostali pacjenci nie poddani terapii komorkami macierzystymi |
The remaining patients did not undergo stem cell therapy |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study can be finished by by researchers or institutional review boards if on the basis of results analyzed during the study, continuing the research can be harmful and dangerous to the research participants.
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Badanie moze zostac zakonczone przez badaczy lub komisja bioetyczna jezeli na podstawie wynikow analizowanych w trakcie badania, dalsze prowadzenie badania moze byc szkodliwe i niebezpieczne dla uczestnikow badania |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |