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    Summary
    EudraCT Number:2013-005371-40
    Sponsor's Protocol Code Number:JP2-171560
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-005371-40
    A.3Full title of the trial
    Medical laser and stem cells in treatment ischemic heart disease
    Użycie lasera medycznego i komórek macierzystych w leczeniu krańcowej
    postaci choroby niedokrwiennej serca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem cells in Heart disease
    Użycie lasera medycznego i komórek macierzystych w leczeniu krańcowej
    postaci choroby niedokrwiennej serca
    A.4.1Sponsor's protocol code numberJP2-171560
    A.5.4Other Identifiers
    Name:Decyzja Narodowego Centrum NaukiNumber:DEC-2013/03/B/NZ5/01437
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSzpital im. Jana Pawla II
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNarodowe Cantrum Nauki
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSzpital im. Jana Pawla II
    B.5.2Functional name of contact pointBIURO WSPIERANIA BADAŃ I ROZWOJU
    B.5.3 Address:
    B.5.3.1Street AddressPradnicka 80
    B.5.3.2Town/ cityKrakow
    B.5.3.3Post code31-202
    B.5.3.4CountryPoland
    B.5.4Telephone number4812614 33 84
    B.5.5Fax number4812614 35 57
    B.5.6E-maila.piwowarczyk-bargiel@szpitaljp2.krakow.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameStem cells
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischemic heart disease
    E.1.1.1Medical condition in easily understood language
    Ischemic heart disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Improvement in angina relief
    Zmniejszenie dolegliwosci wiencowych
    E.2.3Trial contains a sub-study No
    E.3Principal 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%
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 rok
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months, 1 year
    6 miesiecy, 1 rok
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other 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
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pozostali pacjenci nie poddani terapii komorkami macierzystymi
    The remaining patients did not undergo stem cell therapy
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    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.
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No different from the expected normal treatment of that condition

    Nie różni się od standardowego leczenia w tego typu przypadkach
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
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