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    The EU Clinical Trials Register currently displays   43628   clinical trials with a EudraCT protocol, of which   7211   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2015-002929-19
    Sponsor's Protocol Code Number:SCIENCE
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2015-002929-19
    A.3Full title of the trial
    Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE
    Stammzelltherapie bei ischämischer, nicht behandelbarer Herzerkrankung - SCIENCE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem cell therapy in heart failure
    Stammzelltherapie bei Herzinsuffizienz
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSCIENCE
    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 SponsorDepartment of Cardiology, Rigshospitalet
    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 supportRigshospitalet
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Cardiology, 2014, Rigshospitalet
    B.5.2Functional name of contact pointJens Kastrup
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen OE
    B.5.3.3Post code2100
    B.5.4Telephone number004535452819
    B.5.5Fax number004535452705
    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 nameAllogeneic adipose tissue-derived stromal cells
    D.3.2Product code CSCC_ASC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCSCC_ASC
    D.3.9.2Current sponsor codeSCIENCE
    D.3.9.3Other descriptive nameEx vivo cultured human mesenchymal stem cells
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110 mill in 5 ml
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntracardiac use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischemic heart disease and heart failure
    Ischämische Herzerkrankung und Herzinsuffizienz
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure have reduced cardiac pump function, physical
    functional capacity and quality of life in spite of maximal tolerated
    therapy and are candidates for stem cell therapy
    Patienten mit Herzinsuffizienz haben trotz maximal verträglicher Therapie eine reduzierte kardiale Pumpfunktion, Leistungsfähigkeit und Lebensqualität und sind Kandidaten für Stammzelltherapie
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To perform at clinical double-blind placebo-controlled CSCC_ASC
    multicentre study in heart failure patients to investigate the
    regenerative capacity of the CSCC_ASC treatment.
    Durchführung einer doppelblinden, Placebo-kontrollierten CSCC-ASC multizentrischen Studie bei Patienten mit Herzinsuffizienz, um die regenerativen Eigenschaften der CSCC-ASC Therapie zu untersuchen
    E.2.2Secondary objectives of the trial
    Improvement in cardiac function and clinical symptoms
    Verbesserung der kardialen Funktion und der klinischen Symptome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. 30 to 80 years of age
    2. Signed informed consent
    3. Chronic stable ischemic heart disease
    4. Heart failure (NYHA II-III)
    5. LVEF ≤45%
    6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm
    7. Maximal tolerable heart failure medication
    8. Medication unchanged two months prior to inclusion
    9. No option for percutaneous coronary intervention (PCI) or coronary
    artery bypass graft (CABG)
    10. Patients who have had PCI or CABG within six months of inclusion
    must have a new angiography less than one month before inclusion or at
    least four months after the intervention to rule out early restenosis
    11. Patients cannot be included until three months after implantation of
    a cardiac resynchronisation therapy device
    1. Alter 30 – 80 Jahre
    2. Schriftliche Einverständniserklärung
    3. Stabile chronische ischämische Herzerkrankung
    4. Herzinsuffizienz (NYHA II III)
    5. lVEF < 45 %
    6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) bei Sinusrhytmus
    7. Maximal verträgliche Medikation
    8. unveränderte Medikation mindestens 2 Monate vor Einschluss
    9. Keine Option für Percutane Koronarintervention (PCI) oder Koronar-Bypass-Graft (CABG)
    10. Patienten, bei denen innerhalb von 6 Monaten vor Einschluss eine PCI oder CABG durchgeführt wurde, müssen eine neue angiographische Untersuchung längsten eines Monats vor Einschluss oder mindestens 4 Monate nach PCI oder CABG erhalten, um eine frühe Restenose auszuschließen
    11. Patienten, bei denen ein Gerät zur Kardiale Resynchronisierung implantiert wurde, können frühestens 3 Monate nach Implantation eingeschlossen werden.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Heart Failure (NYHA I or IV)
    2. Acute coronary syndrome with elevation of CKMB or troponins,
    stroke or transitory cerebral ischemia within six weeks of inclusion
    3. Other revascularisation treatment within four months of treatment
    4. If clinically indicated the patient should have a coronary angiography
    before inclusion
    5. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or
    valvular disease with option for surgery.
    6. Diminished functional capacity for other reasons such as: obstructive
    pulmonary disease (COPD) with forced expiratory volume (FEV) <1
    L/min, moderate to severe claudication or morbid obesity
    7. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia
    (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or
    thrombocytopenia (thrombocytes < 50 109/L)
    8. Anticoagulation treatment that cannot be paused during cell
    9. Patients with reduced immune response
    10. History with malignant disease within five years of inclusion or
    suspected malignity – except treated skin cancer other than melanoma
    11. Pregnant women
    12. Other experimental treatment within four weeks of baseline tests
    13. Participation in another intervention trial
    1.Herzinsuffizienz (NYHA I oder IV)
    2. Akutes Koronarsyndrom mit erhöhtem CKMB oder Troponin, Schlaganfall oder transitorische ischämische Zerebralischämie innerhalb von 6 Wochen vor Einschluss
    3. Andere Revaskularisierungstherapie innerhalb von 4 Monaten vor Behandlungsbeginn
    4. Wenn klinisch indiziert, sollte bei Patienten vor Einschluss eine Koronarangiographie durchgeführt werden
    5. Moderate bis schwere Aortenstenose (Klappenbereich < 1,3 cm2) oder einer Herzklappenerkrankung mit chirurgischer Indikation
    6. Aus anderen Gründen verminderte Leistungsfähigkeit, z.B. durch COPD mit einer provozierten FEV < 1 L/Min., moderate bis schwere Claudicatio oder morbide Adipositas.
    7. Klinisch signifikante Anämie (Hämoglobin < 6 mmol/L), Leukopenie (Leukozyten < 2 109/L), Leukozytose (Leukozyten >14 109/L) oder Thrombozytopenie (Thrombozyten < 50 109/L)
    8. Antikoagulationstherapie, die während der Zelltransplantation nicht unterbrochen werden kann.
    9. Patienten mit reduzierter Immunreaktion
    10. Patienten mit einer malignen Vorerkrankung innerhalb der letzten 5 Jahre vor Einschluss oder dem Verdacht auf eine maligne Erkrankung einschließlich Melanoma, mit Ausnahme von behandeltem Hautkrebs
    11. Schwangere Frauen
    12. Andere experimentelle Therapien weniger als 4 Wochen vor dem Baseline-Test
    13. Teilnahme an einer anderen interventionellen Studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in left ventricle end-systolic volume
    (LVESV) at 6 months follow-up between CSCC_ASC and placebo patients
    Der primäre Endpunkt ist die Veränderung LVESV (left ventricle end-systolic volume) nach 6 Monaten zwischen CSCC-ASC-und Placebo-Behandlungsarm
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after treatment
    6 Monate nach Behandlung
    E.5.2Secondary end point(s)
    The secondary endpoints are safety evaluated by development of
    allogeneic antibodies and laboratory safety measurements 1 and 6
    months after treatment and changes in left ventricular ejection fraction
    (LVEF), end-diastolic volume and myocardial mass at 6 months followup.
    The changes in left ventricle function will be measured by echocardiography
    (ECHO) or computed tomography (CT). Other secondary endpoints are changes in NYHA, CCS,
    Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 min walking test and NT-pro-
    BNP. In addition, safety of allogeneic CSCC_ASCs with respect to
    incidence and severity of serious adverse events and suspected
    unrelated serious adverse events will be evaluated at 12 months followup.
    A combined endpoint of
    1. death, hospitalization for worsening heart failure including inserting
    of a bi-ventricular pacemaker, hospitalization because of ventricular
    tachycardia or fibrillation and increased heart failure medical treatment
    1, 2 and 3 years after treatment
    2. death, hospitalization for any cardiovascular reason, hospitalization
    for worsening heart failure including inserting of a bi-ventricular
    pacemaker, hospitalization because of ventricular tachycardia or
    fibrillation and increased heart failure medical treatment 1, 2 and 3
    years after treatment.
    Die sekundären Endpunkte sind Sicherheit, evaluiert anhand der Entwicklung von allogenen Antikörpern und Laborparametern jeweils 1 und 6 Monate nach Behandlung sowie Veränderungen in der linksventrikulären Ejektionsfraktion, end-diastolisches Volumen und Myokardmasse nach 6 Monaten.
    Die Veränderungen der linksventrikulären Funktion wird mittels echokardiographischer oder CT-Untersuchung gemessen.
    Weitere sekundäre Endpunkte sind Veränderungen der NYHA-Klassifikation, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-Minuten-Gehtest und NT-proBNP.
    Zusätzlich wird die Sicherheit der allogenen Stammzellgabe CSCC_ASCs in Bezug auf Häufigkeit und Schweregrad von SAEs und SUSARs im 12 Monats-Follow-up bewertet.
    Kombinierter Endpunkt nach 1,2, und 3 Jahren nach Stammzellgabe:
    1. Tod, Hospitalisierung aufgrund verschlechterter Herzinsuffizienz einschließlich der Implantation eines bi-ventrikulären Herzschrittmachers, Hospitalisierung aufgrund von ventrikulärer Tachykardie oder Kammerflimmern und zusätzlicher Behandlung der zugrundliegenden Herzinsuffizienz.
    2. Tod, Hospitalisierung aufgrund kardialer Erkrankung, verschlechterter Herzinsuffizienz einschließlich der Implantation eines bi-ventrikulären Herzschrittmachers, Hospitalisierung aufgrund von ventrikulärer Tachykardie oder Kammerflimmern und zusätzlicher Behandlung der zugrundliegenden Herzinsuffizienz.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 6 months after treatment and 1, 2 and 3 years
    1 und 6 Monate nach Behandlung und nach jeweils 1,2, und 3 Jahren
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Yes
    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 patients will have four follow-up visits the first year after treatment, then the
    safety of the study will be follow year 2 and 3 after the therapy in hospital registries
    Patienten werden im ersten Jahr nach der Behandlung in 4 Follow-up Visiten untersucht, die Sicherheit der Stammzellgabe wird anschließend im Rahmen von Registern im Jahr 2 und 3 untersucht
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 79
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state139
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 139
    F.4.2.2In the whole clinical trial 139
    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 Decision2016-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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