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    Summary
    EudraCT Number:2004-001922-26
    Sponsor's Protocol Code Number:BMI-EU-02-008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-001922-26
    A.3Full title of the trial
    A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)
    A.3.2Name or abbreviated title of the trial where available
    SEISMIC
    A.4.1Sponsor's protocol code numberBMI-EU-02-008
    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 SponsorBioheart, Inc
    B.1.3.4CountryUnited States
    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 nameMyoCell
    D.3.4Pharmaceutical form Implant
    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.3.9.2Current sponsor codeMyoCell
    D.3.9.3Other descriptive nameAutologous Skeletal Muscle Myoblasts
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 million cells to 800 million
    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 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
    Patients with congestive heart failure who have had a previous myocardial infarction.
    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
    There is a primary safety objective and a primary efficacy objective. The primary safety objective is that the MyoCell™ implant will be considered safe if the number of serious adverse events at 3 months and 6 months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis plan. The primary efficacy objective is to demonstrate the response to MyoCell™ implantation on the change in LVEF at 3 and 6 months by MUGA compared to baseline.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objective will be defined in the statistical analysis plan and will include but not be limited to:

    - Six Minute Walk (6MW) distance, NYHA classification, average Quality of Life (QOL) score, hospitalization, readmissions or the need for medical treatment outside of hospitalizations.
    - Contrast aided-Dobutamine Stress Echo (using non-ionic contrast) and Tissue Doppler Imaging for all patients to show improvements in:
    - Global and regional contractility
    - Wall thickness improvements
    - Coronary perfusion (ICD patients only)
    - Cardiac MRI for patients without an ICD to show improvements in:
    - Coronary perfusion
    - A further optional objective will be to assess any changes in infarct size seen after 3 and 6 months, compared to baseline.

    An additional safety objective will be to investigate the safety of the use of the MyoCath™, when used as a means of delivery of MyoCells™ for intracardiac implantation
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    (i) Defined region of myocardial dysfunction related to previous myocardial infarction (between 90 days and 3 years of screening) involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q-wave on the ECG and a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography;

    (ii) New York Heart Association (NYHA) Symptom Class II or III;

    (iii) Patients on optimal medical drug therapy for at least 2 months prior to study entry - defined as following the most current “ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult” ;

    (iv) Age ≥ 18 and ≤ 75 years old;

    (v) Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing within 30 days of screening, assessed using Dobutamine Stress Echocardiography;

    (vi) Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts;

    (vii) Well demarcated transmural myocardial scar, assessed by either MRI (delayed contrast enhanced scan) or echocardiography. Patients must have a minimum myocardial wall thickness of 5mm;

    (viii) Left ventricular ejection fraction at screening of :
    ≥ 20% ≤ 45% (by MUGA scan) for ICD patients
    ≥ 20% ≤ 45% (by MUGA scan) for non-ICD patients;

    (ix) Willing and able to give written informed consent;

    (x) If a female of childbearing potential, serum or urine pregnancy test must be negative within 2 weeks of study treatment;
    E.4Principal exclusion criteria
    (i) Myocardial infarction within 90 days or in excess of 3 years of the patient’s screening visit;

    (ii) New York Heart Association Symptom Class I or IV;

    (iii) Coronary Artery Bypass Grafting (CABG) within 6 months (180 days) prior to scheduled MyoCell™ implantation;

    (iv) Percutaneous Coronary Intervention (PCI) within 3 months (90 days) prior to scheduled MyoCell™ implantation;

    (v) Aortic valve replacement;

    (vi) Heart failure secondary to valvular disease;

    (vii) Left ventricular mural thrombus;

    (viii) Known sensitivity to gentamicin sulfate and/or amphotericin-B;

    (ix) Previous experimental angiogenic therapy and/or myocardial laser therapy;

    (x) Previous severe adverse reaction to nonionic radiocontrast agents;

    (xi) Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in any concurrent study that may confound the results of this study;

    (xii) Serum creatinine > 2.5 mg/dL or end stage renal disease;

    (xiii) Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient’s infectious status;

    (xiv) Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study;

    (xv) Any illness which might affect patient’s survival over the study follow-up period or any illness which, in the Investigator’s judgment, will interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results;

    (xvi) Patients on chronic immunosuppressive transplant therapy;

    (xvii) ICDs implanted less than 6 months prior to cellular implantation procedure. ICD devices reprogrammed during the course of treatment and stable for less than 3 months. Patients fitted with a Bi-V pacer are excluded;

    (xviii) Patients who, in the opinion of the investigator, are not suitable to participate, following review of the catheter information given in the Instructions for Use - MyoCath Percutaneous MicroImplant Delivery System.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints

    (i) Defined Serious Adverse Events (SAE’s) and the comparison of these between the treatment arm and control arm. Pre-existing and concurrent illnesses will be defined and tabulated separately from cell therapy-related adverse events;

    (ii) Routine Clinical laboratory test results - development of clinically significant abnormal lab values will be tabulated and compared for both groups;

    (iii) 12-lead ECG data to evaluate clinically significant changes before and after cellular implantation and compare changes relative to the control group;

    (iv) Clinical status of patient for the duration of the study with comparison of the treatment group against the control group, including the number and mean length of stay for hospitalizations;

    (v) Resting ECHO data: to evaluate changes in pericardial effusion before and after cellular implantation and compare changes relative to the control group;

    (vi) Holter monitoring data: to evaluate clinically significant changes before and after cellular implantation and compare changes relative to the control group;

    (vii) Assessment of the safety of the use of the MyoCath™, when used as a means of delivery of MyoCells™ for intracardiac implantation will be assessed by recording and analyzing device-specific Adverse Events;

    Primary Efficacy Endpoints

    (i) The change in Left Ventricular Ejection Fraction (LVEF) at 3 and 6 months by MUGA compared to baseline;

    The following Secondary Endpoints will be evaluated to further demonstrate the effects of MyoCell™ treatment:

    (i) The results of the Six Minute Walk for patients in the treatment arm will be compared to the results for the control arm at 3 and 6 months;

    (ii) Change or stabilization of NYHA Classification for the treatment group will be compared to the control group at 3 and 6 months;

    (iii) Hospitalization, readmissions or the need for medical treatment outside of hospitalizations - number, length of stay and reasons [reasons segregated into “planned” or “unplanned”];

    (iv) Patient survival of the treatment group will be compared to survival of the control group;

    (v) Contrast aided-Dobutamine Stress Echo (using non-ionic contrast) and Tissue Doppler Imaging for all patients at 3 and 6 months to show improvements in:
    - Global and regional contractility
    - Wall thickness improvements
    - Coronary perfusion (ICD patients only);

    (vi) Cardiac MRI for patients without an ICD to show improvements in:
    - Coronary perfusion;

    (vii) The Quality of Life scores for patients in the treatment arm will be compared to scores in the control arm at 1, 3 and 6 months. Quality of Life will be assessed using the following:
    - Patients graded using the NYHA classification;
    - Patients will be asked to complete a Minnesota Living with Heart Failure Quality of Life (QOL) questionnaire;

    (viii) A further optional objective will be the assessment of any changes in infarct size seen after 3 and 6 months, compared to baseline, using delayed contrast enhanced MRI scans. This will be done on a patient by patient basis;
    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 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 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
    Standard medical therapy
    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
    The trial will end when the last patient recruited has completed their six month follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    All patients will continue with the standard medical treatment on completion of the study. Their therapy will be monitored and modified as necessary. There is not thought to be any increased risk other than that associated with the medical condition.
    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 Decision2005-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-23
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