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    Summary
    EudraCT Number:2011-000595-33
    Sponsor's Protocol Code Number:2011-01-01REPEAT
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-09-13
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-000595-33
    A.3Full title of the trial
    Randomized controlled trial to compare the effects of single versus repeated intracoronary application of autologous bone marrow-derived mononuclear cells on total and SHFM-predicted mortality in patients with chronic post-infarction heart failure

    REpetitive Progenitor cEll therapy in Advanced chronic hearT failure (REPEAT trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Repeated application of bone marrow-derived stem cells to treat chronic post-infarction heart failure
    A.3.2Name or abbreviated title of the trial where available
    REPEAT
    A.4.1Sponsor's protocol code number2011-01-01REPEAT
    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 SponsorGoethe University Frankfurt
    B.1.3.4CountryGermany
    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 supportGoethe University Frankfurt
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGoethe University
    B.5.2Functional name of contact pointCardiology
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+4906963015789
    B.5.5Fax number+4906963016374
    B.5.6E-mailzeiher@em.uni-frankfurt.de
    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 namet2c001
    D.3.2Product code t2c001
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codet2c001-DS
    D.3.9.3Other descriptive nameBone marrow-derived progenitor cells
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 500
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/626742/2010
    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
    Chronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-III; and with open vessel / bypass sullpying the previously infarcted area
    E.1.1.1Medical condition in easily understood language
    Chronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-III
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improve mortality in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells.
    E.2.2Secondary objectives of the trial
    Improve morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass
    • Left ventricular ejection fraction (LVEF) ≤ 45% on echocardiography
    • Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment
    • Age > 18 and expected to survive > 1 year
    • Written informed consent
    • Women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial
    E.4Principal exclusion criteria
    • Non-ischemic cardiomyopathy
    • Foreseeable necessity for revascularization in other vessel than the infarct vessel at the time of study therapy
    • Hemodynamic relevant severe valvular disease with indication for operative / interventional revision
    • Heart failure with preserved ejection fraction (diastolic heart failure),
    LVEF > 45%
    • Unstable Angina
    • Severe peripheral artery occlusive disease (≥ Fontaine stadium III)
    • Active infection (C-reactive protein > 10 mg/dl), any chronic inflammatory disease
    • Neoplastic disease without documented remission in the last 5 years
    • Stroke ≤ 3 months
    • Impaired renal function (Serum creatinine > 2,5 mg/dl or eGRF (MDRD) ≤30l/ min) at the time of study inclusion
    • Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR > 1,5).
    • Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 g/dl), thrombocytopenia < 100.000/µl)
    • Splenomegaly
    • Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin
    • History of bleeding disorder
    • Gastrointestinal bleeding ≤ 3 months
    • Major surgery or trauma ≤ 3 months
    • Uncontrolled hypertension
    • Pregnancy, lactation period
    • Mental retardation
    • Previous cardiac cell therapy within last 12 months
    • Participation in another clinical trial ≤ 30 days
    E.5 End points
    E.5.1Primary end point(s)
    2-year observed mortality is significantly lower in patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001) compared to patients receiving 1 intracoronary application of autologous bone marrow-derived cells (t2c001)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after inclusion into the trial
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    - In patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001), the observed mortality is significantly lower than the SHFM-predicted mortality at 2-year follow-up

    Comparison between the 2 treatment groups at 2-year and 5-year follow-up
    - Cardiac mortality, cardiovascular mortality
    - Rehospitalisation for heart failure
    - Ischemic cardiac events (STEMI, NSTEMI, ACS)
    - Coronary revascularisations (PCI / CABG)
    - Heart transplantation, Assist-device implantation
    - New resynchronization therapy, ICD implantation
    - NYHA-Status, NT-proBNP serum levels
    - Minnesota Living with Heart Failure Questionnaire

    Prespecified combined clinical endpoints:
    o Death and rehospitalisation for heart failure
    o Cardiac Death and rehospitalisation for heart failure
    o Cardiac and Cardiovascular Death and rehospitalisation for heart failure
    o Death and myocardial infarction
    o Death and myocardial infarction and rehospitalisation for heart failure
    o Death and any cardiovascular event

    Safety endpoints:
    - All in-hospital events (during hospitalization for cell therapy)
    - Life-threatening arrhythmias (sustained ventricular tachycardia; ventricular fibrillation and cardiopulmonary resuscitation)
    - Any new malignant disease
    - Bleeding events
    - Safety of intracoronary application of autologous bone marrow-derived cells (t2c001) (procedural complications, adverse events at 30 days, SAEs at 4 months after each cell application)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years after inclusion into the trial
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    single versus sequentential treatment
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 676
    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)
    Standard treatment of heart failure
    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 Decision2013-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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