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    The EU Clinical Trials Register currently displays   36095   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001495-11
    Sponsor's Protocol Code Number:BAMI-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-04-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-001495-11
    A.3Full title of the trial
    The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BMMNC) on all causemortality in acute myocardial infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised trial to see if injecting patients' own bone marrow derived stem cells through their coronary artery changes mortality rate in patients after suffering from a heart attack
    A.3.2Name or abbreviated title of the trial where available
    BAMI
    A.4.1Sponsor's protocol code numberBAMI-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01569178
    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 SponsorQueen Mary University London
    B.1.3.4CountryUnited Kingdom
    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 supportEuropean Commission FP7 programme
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Mary University London
    B.5.2Functional name of contact pointSheik Dowlut
    B.5.3 Address:
    B.5.3.1Street AddressSt James' Building, London Chest Hopsital, Bonner Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE2 9JX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402089832216
    B.5.5Fax number4402089832262
    B.5.6E-mails.dowlut@qmul.ac.uk
    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 nameautologous bone marrow derived progenitor cells
    D.3.2Product code t2c001
    D.3.4Pharmaceutical form Suspension for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary 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) No
    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 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 Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/626742/2000
    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
    Myocardial Infarction with reduced Left Ventricular ejection fraction
    E.1.1.1Medical condition in easily understood language
    Heart attack resulting in reduced pumping capacity of the heart
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to assess if the administration of a single injection of patient's own bone marrow derived stem cells into their coronary arteries will reduce all cause mortality.
    E.2.2Secondary objectives of the trial
    Looking at the time from randomisation to cardiac and cardiovascular events including cardiac death.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent
    2. Men and women of any ethnic origin aged ≥ 18 years
    3. Patients with acute STelevation
    myocardial infarction as defined by the universal definition of AMI.
    4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom
    onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention
    (PCI) within 24 hours after thrombolysis
    5. Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative
    echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy
    6. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
    E.4Principal exclusion criteria
    1. Participation in another clinical trial within 30 days prior to randomisation
    2. Previously received stem/progenitor cell therapy
    3. Pregnant or nursing women
    4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the
    study or to follow the protocol
    5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BMMNC
    infusion
    (additional revascularisations after primary PCI and before BMMNC
    cell infusion are allowed)
    6. Cardiogenic shock requiring mechanical support
    7. Platelet count <100,000/μl, or hemoglobin <8.5 g/dl
    8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl
    9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
    10. Clinically significant bleeding within 3 months prior screening
    11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
    12. Life expectancy of less than 2 years from any noncardiac
    cause or neoplastic disease
    E.5 End points
    E.5.1Primary end point(s)
    Time from Randomisation to all-cause-death
    E.5.1.1Timepoint(s) of evaluation of this end point
    The outcome will be assessed at 30 days and every 3 months until the end of the study or up to two years after
    randomisation with a minimum of 2 years follow up.
    E.5.2Secondary end point(s)
    Time from randomisation to cardiac death
    Time from randomisation to cardiovascular death or rehospitalisation due to heart failure
    Time from randomisation to cardiovascular rehospitalisation for:
    Recurrent myocardial infarction
    Coronary revascularization procedures
    Heart Failure
    Unplanned implantation of implantable cardioverter defibrillator (ICD)/cardiac resynchronisation therapy (CRT)
    device after the initial hospitalisation discharge
    Stroke
    Safety endpoints are:
    Incidence of adverse events
    Incidence of bleeding by bleeding academic research consortium (BARC) definitions Incidence of syncopes
    Incidence of arrhythmias (atrial fibrillation/ventricular tachycardia)
    Incidence of neoplastic diseases
    E.5.2.1Timepoint(s) of evaluation of this end point
    The outcome will be assessed at 30 days and every 3 months until the end of the study or up to two years after
    randomisation with a minimum of 2 years follow up.
    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) No
    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 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
    unspecified control group
    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 EEA40
    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
    This trial is designed as an event-driven trial. The study will be terminated after 450 events have been observed and this is estimated to happen at 2 year follow up for a total of 3000 patients recruited.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1200
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 3000
    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)
    This is not applicable as the intervention will be a one off treatment only
    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 Decision2013-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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