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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-017966-21
    Sponsor's Protocol Code Number:TMR-SC-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-017966-21
    A.3Full title of the trial
    ENSAYO CLÍNICO PROSPECTIVO, CONTROLADO Y ALEATORIZADO DE REGENERACIÓN CELULAR CARDIACA CON LÁSER Y CÉLULAS MADRES AUTÓLOGAS DE MÉDULA ÓSEA, EN PACIENTES CON ENFERMEDAD CORONARIA Y ANGINA REFRACTARIA
    A.4.1Sponsor's protocol code numberTMR-SC-02
    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 SponsorDr. Guillermo Reyes Copa
    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 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 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 nameRevascularización transmiocárdica (TMR) con láser YAG Holmium más células madre del propio paciente
    D.3.4Pharmaceutical form
    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 INNCéluas madre autólogas de médula ósea
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.8Extractive medicinal product Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeCelulas madre de médula ósea autólogas extraídas del propio paciente. Dichas células se aplican en los bordes de los canales que genera la sonda.
    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
    Enfermedad coronaria difusa no susceptible de intervencionismo coronario y con angina a pesar de un correcto tratamiento médico
    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
    Comparar los resultados clínicos y funcionales que la terapia de revascularización transmiocárdica en combinación con la implantación de células madre autólogas de médula ósea frente a la revascularización transmiocárdica aislada en pacientes con enfermad coronaria difusa y angina refractaria.
    E.2.2Secondary objectives of the trial
    Analizar de forma objetiva mediante un estudio de captación de isótopos y resonancia cardiaca magnética las variaciones anatomofisiológicas que la terapia pueda producir.
    Analizar mediante un estudio inmunofenotípico de poblaciones celulares infundidas la composición de las células extraídas e implantadas en el miocardio y su correlación con los resultados clínicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pacientes mayores de 18 años de edad.
    • Pacientes con al menos una zona de isquemia miocárdica o de infarto de miocardio crónico del ventrículo izquierdo demostrado mediante alguna prueba de imagen no susceptibles de revascularización convencional y angina refractaria al tratamiento médico.
    • Fracción de Eyección > 25% medida en los seis meses previos al procedimiento.
    • Los participantes deben ser competentes mentalmente dando su consentimiento para la inclusión en el ensayo clínico.
    E.4Principal exclusion criteria
    • Pacientes con angina inestable definida como la necesidad de nitritos intravenosos en el momento de la cirugía.
    • Infarto de miocardio reciente (dentro de los 15 días previos al procedimiento).
    • Pacientes con insuficiencia cardiaca descompensada en el momento de la cirugía.
    • Arritmia severa o que amenace la vida (ej: taquicardia o fibrilación ventricular) en la semana previa al procedimiento.
    • Pacientes que requieran algún tipo de cirugía valvular concomitante.
    • Pacientes con criterios de enfermedad pulmonar obstructiva severa que se considere por parte del equipo médico que no son capaces de soportar una anestesia general.
    E.5 End points
    E.5.1Primary end point(s)
    Se recopilaran las variables demográficas e historia cardiovascular de los pacientes (anexo 1). Se recogerán todas las variables intra y postoperatorias y los datos obtenidos por citometría en cuanto al resultado de número de células inyectadas en cada paciente (células mononucleares totales, CD34+ y CD133).
    Se realizará antes de la cirugía y a los 12 meses posteriores a esta una prueba de provocación de isquemia mediante isótopos para medir el porcentaje de territorio isquémico (SPECT o Tomografía Computerizada por Emisión de Fotones Individuales) así como la capacidad de esfuerzo máxima antes de la aparición de la angina.
    Mediante un ecocardiograma y una resonancia cardiaca pre y postoperatoria se estudiara la fracción de eyección del ventrículo izquierdo, el volumen telesistólico y el volumen telediastólico del ventrículo izquierdo.
    La mejora clínica de los pacientes se estudiará según la clasificación de la NYHA para la angina y se recogerán como variables anexas la cantidad de medicación cardiovascular y número de nitratos sublinguales mensuales, número de ingresos por dolor torácico en urgencias, número de ingresos hospitalarios por dolor torácico. La variable principal a estudio es el porcentaje de pacientes que alcanzan una disminución en dos niveles de la clasificación NYHA para la angina.
    Para la valoración subjetiva de la calidad de vida que el paciente percibe tener se realizará el cuestionario EQ-5D.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Ciego para algunos evaluadores del estudio
    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
    Revascularización transmiocárdica con láser
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 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 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 state20
    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 Decision2010-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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