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    Summary
    EudraCT Number:2013-000915-26
    Sponsor's Protocol Code Number:CMMo-OCC-2012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2013-04-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-000915-26
    A.3Full title of the trial
    Clinical Trial Phase III single-center, open-label efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with occlusion Autologous chronic coronary revascularization and ventricular dysfunction previously
    Ensayo Clínico Fase III Unicéntrico, Abierto, Aleatorizado sobre eficacia de la Infusión Intracoronaria de células Mononucleadas de Médula Ósea Autóloga en Pacientes Con Oclusión Coronaria Crónica y Disfunción Ventricular previamente revascularizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To determine the efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with autologous chronic coronary occlusion previously revascularized with stents in terms of improvement of ventricular function determined by magnetic resonance image.
    Determinar la eficacia de la infusión intracoronaria de células mononucleadas de médula ósea autóloga en pacientes con oclusión coronaria crónica previamente revascularizada con stent en términos de mejoría de la función ventricular determinada por resonancia magnética.
    A.4.1Sponsor's protocol code numberCMMo-OCC-2012
    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 SponsorFUNDACIÓN PROGRESO Y SALUD
    B.1.3.4CountrySpain
    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 supportConsejeria de Salud de Andalucia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN PROGRESO Y SALUD
    B.5.2Functional name of contact pointAna Cardesa Gil
    B.5.3 Address:
    B.5.3.1Street Addressc/ Maese Rodrigo, nº1, 1º Izq
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955019040
    B.5.5Fax number0034955019019
    B.5.6E-mailana.cardesa@juntadeandalucia.es
    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 nameCélulas Mononucleadas de Médula Ósea Autóloga
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameMononuclear bone marrow cells
    D.3.10 Strength
    D.3.10.1Concentration unit kg kilogram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500000000 to 1000000000
    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 Yes
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic coronary occlusion
    Oclusión coronaria crónica
    E.1.1.1Medical condition in easily understood language
    Chronic coronary occlusion
    Oclusión coronaria crónica
    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 10011086
    E.1.2Term Coronary artery occlusion
    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
    To determine the efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with autologous chronic coronary occlusion previously revascularized with stents in terms of improvement of ventricular function determined by magnetic resonance image.
    Determinar la eficacia de la infusión intracoronaria de células mononucleadas de médula ósea autóloga en pacientes con oclusión coronaria crónica previamente revascularizada con stents en términos de mejoría de la función ventricular determinada por resonancia magnética.
    E.2.2Secondary objectives of the trial
    1. - To design, in view of the results obtained, a protocol best suited for the treatment of chronic coronary occlusion.
    2. - To study the changes in the functional status of these patients.
    3 - Analysis of potential cardiac events during follow-up (death, myocardial infarction, repeat revascularization).
    4. - Study of changes in global and segmental function of the left ventricle through the study of myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography comparatively amongst patients and between groups
    1.- Diseñar, a la vista de los resultados obtenidos, un protocolo más idóneo de tratamiento de la oclusión coronaria crónica.
    2.- Estudiar lo cambios en el grado funcional de estos pacientes.
    3- Análisis de posibles eventos cardiacos durante el seguimiento (mortalidad, infarto, necesidad de nueva revascularización).
    4.- Estudio de los cambios en la función global y segmentaria del ventrículo izquierdo mediante el estudio de la deformación miocárdica con ecocardiografía Speckle tracking bidimensional (EST2D) y ecocardiografía tridimensional de forma comparativa entre los mismos pacientes y entre grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. - Patients of both sexes with atherosclerotic coronary disease and chronic occlusions older than 3 months that has been achieved successful recanalization, medicated stents implanted, and where it persists despite ventricular dysfunction.
    2.-Age between 18 and 80 years.
    2. - The baseline ventricular function recanalization catheterization (performed approximately 3 months earlier) should be less than 45% ejection fraction.
    3. - In the magnetic resonance image performed at 3 months of recanalization, the ejection fraction of the patient should remain below 45%.
    1.- Pacientes de ambos sexos con enfermedad coronaria arteriosclerótica y oclusiones crónicas de más de 3 meses en los que se haya conseguido la recanalización con éxito, implantandose stents medicados, y en los que a pesar de ello persista la disfunción ventricular.
    2.-Edad comprendida entre 18 y 80 años.
    2.- La función ventricular basal en el cateterismo de recanalización (realizado aproximadamente 3 meses antes) deberá ser inferior al 45% de fracción de eyección.
    3.- En la resonancia magnética realizada a los 3 meses de la recanalización, la fracción de eyección del paciente deberá continuar siendo inferior al 45%.
    E.4Principal exclusion criteria
    1. - Patients with chronic occlusion recanalizadas not successful.
    2. - Patients with improvement of ejection fraction to values ??above 45% at 3 months after recanalization ..
    3. - Positive serology for HIV, HCV or HBV.
    4. - Coexistence of other serious systemic diseases or contraindications to dual antiplatelet therapy (clopidogrel and aspirin).
    5. - Coexistence of any blood disease.
    6. - Pregnant women, lactating, or of childbearing potential not using effective contraception.
    7. - Patients who are currently participating or have completed their participation in a clinical trial in a period of less than three months.
    8. - Patients with malignant or pre-malignant.
    9. - Patients who can not perform a magnetic resonance device being metallic carrier (prosthesis, defibrillators, pacemakers etc.).
    1.- Pacientes con oclusiones crónicas no recanalizadas con éxito.
    2.- Pacientes con mejorías de la fracción de eyección hasta valores superiores al 45% a los 3 meses tras la recanalización..
    3.- Serología positiva para VIH, VHC o VHB.
    4.- Coexistencia de otras enfermedades sistémicas graves o contraindicación para la doble antiagregación (clopidogrel y aspirina).
    5.- Coexistencia de cualquier tipo de enfermedad hematológica.
    6.- Mujeres embarazadas, en periodo de lactancia, o en edad fértil que no estén usando un método anticonceptivo eficaz.
    7.- Pacientes que estén actualmente participando o hayan finalizado su participación en un ensayo clínico en un periodo inferior a 3 meses.
    8.- Pacientes con tumores malignos o pre-malignos.
    9.- Pacientes en los que no se puede realizar una resonancia magnética por ser portador de dispositivos metálicos (prótesis, desfibriladores, marcapasos, etc).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change in ejection fraction measured by magnetic resonance image between inclusion and at 6 months follow-up
    La variable principal del estudio será el cambio en la fracción de eyección medida por resonancia magnética entre la inclusión y a los 6 meses de seguimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    E.5.2Secondary end point(s)
    1. Grade Changes NYHA functional comparatively between groups.
    2. Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization).
    3. Need for hospitalization or major arrhythmias. It will assess the presence or absence of symptoms or arrhythmias during the 6 month follow-up. To do this, patients will be followed from the clinical point of view so close, with frequent phone calls and periodic revisions of an outpatient hospital.
    4. Changes in global function and left ventricular segmental by studying myocardial deformation dimensional speckle tracking echocardiography (EST2D) and three-dimensional echocardiography in a comparison between the conditions for monitoring in each patient and between groups.
    1. Cambios de Grado funcional de la NYHA de forma comparativa entre los grupos.
    2. Posibles eventos cardiacos durante el seguimiento (mortalidad, infarto, necesidad de nueva revascularización).
    3. Necesidad de ingreso hospitalario o presencia de arritmias mayores. Se valorará la presencia o ausencia de síntomas o arritmias durante los 6 meses de seguimiento. Para ello, los pacientes serán seguidos desde el punto de vista clínico de forma estrecha, con llamadas telefónicas frecuentes y revisiones hospitalarias periódicas de forma ambulatoria.
    4. Cambios en la función global y segmentaria del ventrículo izquierdo mediante el estudio de la deformación miocárdica con ecocardiografía Speckle tracking bidimensional (EST2D) y ecocardiografía tridimensional de forma comparativa entre las condiciones de seguimiento en cada paciente y entre grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    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 No
    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
    Tratamiento médico convencional
    Conventional medical treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 total duration of approximately 36 months from the inclusion of the first patient.
    La duración total será de aproximadamente 36 meses desde la inclusión del primer paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    Not applicable
    No aplicable
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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