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    Summary
    EudraCT Number:2013-002015-98
    Sponsor's Protocol Code Number:CMMo/MD/2013
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-12
    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 number2013-002015-98
    A.3Full title of the trial
    Clinical trial phase III multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intracoronary infusion of autologous adult stem mononuclear bone marrow unexpanded on functional recovery in patients with dilated cardiomyopathy and heart failure.
    Ensayo clínico multicéntrico fase III, doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia de la infusión intracoronaria de Células Mononucleares troncales adultas autólogas de médula ósea no expandidas sobre la recuperación funcional en pacientes con miocardiopatía dilata e insuficiencia cardiaca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy of intracoronary infusion of autologous bone marrow mononuclear in patients with dilated cardiomyopathy
    ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA DE LA INFUSIÓN INTRACORONARIA DE CÉLULAS MONONUCLEADAS DE MÉDULA ÓSEA AUTÓLOGA EN PACIENTES CON MIOCARDIOPATÍA DILATADA E INSUFICIENCIA CARDIACA
    A.4.1Sponsor's protocol code numberCMMo/MD/2013
    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 supportFundación Progreso y Salud
    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 nº 1, 1º izda
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955019040NA
    B.5.5Fax number0034955019019NA
    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 Mononucleares troncales adultas autólogas de médula ósea no expandidas
    D.3.4Pharmaceutical form Solution for infusion
    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.3.8INN - Proposed INNcélulas mononucleares troncales adultas autólogas de médula ósea no expandidas
    D.3.9.2Current sponsor codeCMMo
    D.3.9.3Other descriptive namecélulas mononucleares troncales adultas autólogas de médula ósea no expandidas
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500000000 to 700000000
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    dilated cardiomyopathy
    Miocardiopatía dilatada
    E.1.1.1Medical condition in easily understood language
    dilated cardiomyopathy
    Miocardiopatía dilatada
    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 10007636
    E.1.2Term Cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10056419
    E.1.2Term Dilated cardiomyopathy
    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 evaluate the efficacy of intracoronary injection of autologous bone marrow progenitor, improving ventricular function in patients with idiopathic dilated cardiomyopathy.
    Valorar comparativamente la eficacia de la inyección intracoronaria de células progenitoras de médula ósea autóloga, en la mejora de la función ventricular, en pacientes con Miocardiopatía Dilatada de origen idiopático que reciben tratamiento médico convencional, frente a un grupo control al que se efectuará un tratamiento médico convencional exclusivamente.
    E.2.2Secondary objectives of the trial
    To analyze the clinical, functional and biological predictors of good response to treatment with adult stem cells autologous mononuclear bone marrow expanded in terms of functional recovery.
    Analizar los factores clínicos, funcionales y biológicos predictores de buena respuesta al tratamiento con células mononucleares troncales adultas autólogas de médula ósea no expandidas, en términos de recuperación funcional.
    Para ello se evaluarán los siguientes parámetros: grado funcional (NYHA), BNP, Prueba de esfuerzo (tiempo de ejercicio) y parámetros ecocardiográficos de función ventricular.

    Determinar, a la vista de los resultados obtenidos, el protocolo idóneo de aplicación de terapia celular al tratamiento de MD, tanto en lo relativo a las características ideales del injerto medular como a los pacientes más susceptibles de ser beneficiarios del mismo, con el fin de establecer una estrategia definitiva de inclusión de la terapia celular en el tratamiento estándar de la MD en un futuro cercano si los resultados así lo aconsejan.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with dilated cardiomiophaty

    2. Minimal evolution from the diagnosis of 6 months

    3.Absence of coronary injuries.

    4.Patients with pharmacological stable treatment for at least 6 months prior to enrollment.

    5.FEVI <40 % or FEVI 40 %-50 % if VTDVI> 110 ml/m2.

    6.Presence sinus rhythm.

    7.Patients who have given they informed consent for participation in the clinical trial.

    8.The women of childbearing potential must have a negative pregnancy test.
    1.Pacientes diagnosticados de MD establecida (1), con síntomas y/o signos de insuficiencia cardiaca de etiología idiopática.

    2.Evolución mínima desde el diagnóstico de 6 meses (2),

    3.Ausencia de lesiones coronarias comprobadas mediante TAC multicorte y/o estudio hemodinámico.

    4.Pacientes con tratamiento farmacológico estable durante al menos 6 meses previos a su inclusión (de forma individualizada ajustándose según BNP y grado funcional).

    5.FEVI< 40% o FEVI 40%-50% si VTDVI > 110 ml/m2.

    6.Presencia de ritmo sinusal.

    7.Pacientes que otorguen su consentimiento informado para la participación en el ensayo clínico.

    8.Parámetros analíticos normales

    9.Las mujeres en edad fértil deberán obtener resultados negativos en una prueba de embarazo realizada en el momento de la inclusión en el estudio y comprometerse a usar un método anticonceptivo médicamente aprobado mientras dure el estudio.
    E.4Principal exclusion criteria
    1. Dilated cardiomyopathy of toxic origin, or ischemic diseases.
    2. Recent history of myocarditis.
    3. Patients suceptible of treatment with resynchronization
    4. Patients in active waiting-list of cardiac Transplant
    5. Coexistence of other systemic serious diseases.
    6. Coexistence of any type of hematologic disease.
    7. Pregnant women, Breast-Feeding, or in fertile age that they are not using a contraceptive effective method.
    8. Patients with malignant or pre-malignant tumors.
    9. Positive serology for HBV, HCV or HIV.
    10. Patients who at the time of inclusion in the trial are taking any medications prohibited by the protocol. We define a "washout period" of two months in order to be included in the trial.
    1.MD de origen tóxico, enfermedades por depósito o isquémicas.

    2.Antecedentes recientes de miocarditis.

    3.Pacientes susceptibles de tratamiento con resincronización. Serán pacientes susceptibles de resincronización aquellos pacientes con IC que tengan un QRS > 150 y que tengan un grado funcional III, IV, que no respondan al tratamiento farmacológico.

    4.Pacientes en lista de espera activa de Trasplante cardiaco.

    5.Coexistencia de otras enfermedades sistémicas graves.

    6.Coexistencia de cualquier tipo de enfermedad hematológica.

    7.Mujeres embarazadas, en periodo de lactancia, o en edad fértil que no estén usando un método anticonceptivo eficaz.

    8.Pacientes que estén actualmente participando o hayan finalizado su participación en un ensayo clínico en un periodo inferior a 3 meses.

    9.Pacientes con tumores malignos o pre-malignos.

    10.Serología positiva para HBV, HCV o HIV.

    11.Pacientes que en el momento de la inclusión en el ensayo estén tomando algún medicamento prohibido por protocolo. Se define un ?periodo de lavado? de 2 meses para poder ser incluido en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Clinical evaluation and determination of NYHA functional class
    2 - Determination of B-type natriuretic peptide
    3 - Echocardiogram
    4 - Evaluation of functional capacity.
    7 - cardiac catheterization.
    1- Evaluación clínica y determinación del grado funcional de la NYHA
    2- Determinación de BNP (péptido Natriurético)
    3- Ecocardiograma
    4- Evaluación de la capacidad funcional mediante prueba de esfuerzo sin medición de consumo de oxígeno, determinándose en ellos el real, el teórico esperado y el tiempo de ejercicio.
    7- Cateterismo cardiaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    -The degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up.
    -The presence or absence of symptoms or arrhythmias during the first 12 months and clinical functional class.
    -Time of evolution from diagnosis of dilated cardiomiophaty to the enrrolment of the patient in the clinical trial
    Se analizará el grado de mejoría clínica basado en la ausencia de eventos cardiacos mayores (MACE) durante el seguimiento, definidos como muerte de causa cardiaca, empeoramiento clínico que indique la inclusión del paciente en programa de trasplante cardiaco, necesidad de ingreso hospitalario o presencia de arritmias mayores.
    Se valorará la presencia o ausencia de síntomas o arritmias durante los primeros 12 meses y grado funcional clínico. 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.
    También se define como variable secundaria el tiempo de evolución desde el diagnóstico de la MD idiopática hasta la inclusión del paciente en el ensayo clínico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years3
    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: 51
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state51
    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)
    NA
    No aplica
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-23
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