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    Summary
    EudraCT Number:2005-004034-41
    Sponsor's Protocol Code Number:21267983
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-10-14
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-004034-41
    A.3Full title of the trial
    Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure Phase 2 Study Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) Study
    A.3.2Name or abbreviated title of the trial where available
    MAGIC
    A.4.1Sponsor's protocol code number21267983
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenzyme Europe B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameCultured Autologous Skeletal Myoblast Cells
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameAutologous cultured skeletal myoblasts, cultured from biopsy
    D.3.10 Strength
    D.3.10.3Concentration numberN/A to N/A
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSuspension 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 Failure
    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
    The coprimary objectives of this study are to assess the recovery of contractility in akinetic myocardial segments that have received transplanted skeletal myoblasts as measured by echocardiogram, and to evaluate the change in left ventricular ejection fraction (LVEF).
    E.2.2Secondary objectives of the trial
    •Assess freedom from Major Adverse Cardiac Events (MACE).

    •Monitor the evolution of overall left ventricular function as measured by echocardiogram and assessed by ejection fraction and diastolic and valvular function.

    •Monitor recovery of metabolic viability and blood flow in the transplant area as evaluated by positron emission tomography (PET) in a subset of patients and at selected sites.

    •Assess change in functional state, assessed using the New York Heart Association (NYHA) classification.

    •Evaluate change in quality of life, assessed using the SF-36® Health Survey.

    •Evaluate the safety and efficacy of 2 different doses of skeletal myoblasts for further testing in a confirmatory Phase 3 trial.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients must meet the following criteria to be enrolled in this study:
    1. Patient must be > = 18 and < = 80 years of age.
    2. Patient must have a recommendation for a coronary bypass, preferably with cardiopulmonary bypass support. All patients meeting this criterion may be included, including those with target injection areas that may or may not be amenable to revascularization.
    3. Patient must have an alteration in left ventricular function, defined as an ejection fraction (EF) of < = 35% and > = 15% (determined by echocardiography and confirmed by the core laboratory).

    4.Patient must have significant myocardial dysfunction from a previous myocardial infarction demonstrated by the existence of akinesia affecting more than 2 accessible, contiguous left ventricular segments (out of 16) on a basal state echocardiogram, with no viability after stimulation with low dose dobutamine.

    5.The left ventricular myocardial infarction (Q wave or positive enzyme) targeted for study injections must have occurred > = 4 weeks prior to screening.

    6.Patient must qualify for insertion of an ICD device. Patient must have an ICD upon enrollment, receive an ICD before CABG surgery and study treatment or receive an ICD prior to discharge from the hospital following CABG surgery.

    7.Patient should be a NYHA functional class I-III, who is receiving optimal contemporary medical management (e.g., ACE inhibitors, beta-blockers, diuretics, etc.). In Canada, only patients classified as NYHA Class II or III will be eligible for enrollment.

    8.Fertile female patients with negative urine pregnancy test at screening and on the day of treatment prior to autologous skeletal myoblast administration.

    9.Fertile female patients who have agreed to follow an approved method of contraception to avoid pregnancy for 60 days after receiving autologous skeletal myoblast administration (or longer if required by concomitant medication (e.g., amiodarone).

    10.Patient must be committed to following the protocol requirements for 2 years as evidenced by written informed consent.
    E.4Principal exclusion criteria
    1.Need for a rapid surgical coronary revascularization (< = 21 days)

    2.Need for any other related cardio-surgical measure during coronary surgery (e.g., mitral valve repair or valve replacement)

    3.Patient with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery

    4.Patients receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)

    5.Patient with cardiomyopathy presumed to be of non-ischemic origin (e.g., hypertrophic cardiomyopathy)

    6.Patient for whom adequate echocardiography, or other required study procedures, cannot be performed for technical reasons

    7.Patient for whom low dose of dobutamine, required for the identification of non-viable, scarred myocardium, is contra-indicated (e.g., recent sustained ventricular tachycardia and ventricular fibrillation)

    8.Patient with advanced heart failure (e.g., NYHA IV heart failure symptoms, or in need of a heart transplant) who does not respond to optimal medical therapy and does not improve to at least Class III symptoms 30 days prior to skeletal muscle biopsy

    9.Patient infected with the hepatitis C virus; the hepatitis B virus (HBs + antigen); patient who is HIV-1 or HIV-2 positive; HTLV-1 positive; Ag P24 positive (this exclusion criteria refers only to regions where this testing is required (e.g. France)

    10.Patient with hemophilia; long-term immunosuppressive treatment, including with corticosteroids; stage III-IV arteriopathy of the lower limbs; significant muscular amyotrophia; peripheral muscular illness; serious intellectual deterioration or neuro-psychiatric disorders that would make follow-up difficult

    11.Patient with allergies to gentamicin or other aminoglycosides, allergies to study required medications or imaging agents

    12.Female patient who is pregnant, nursing, or fertile and using either no or an inadequate form of contraception

    13.Illness other than ischemic heart failure that makes the short-range prognosis for survival questionable

    14.Simultaneous participation in another study with an investigational study agent
    E.5 End points
    E.5.1Primary end point(s)
    The coprimary efficacy endpoints are:

    •the recovery of contractility in within previously akinetic myocardial segments at Month 6

    •the absolute change from baseline to Month 6 in LVEF.
    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 No
    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 Information not present in EudraCT
    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) 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 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 Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years6
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2005-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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