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    Summary
    EudraCT Number:2007-004906-28
    Sponsor's Protocol Code Number:TECAM-QUIRÚRGICO
    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:2007-11-05
    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 number2007-004906-28
    A.3Full title of the trial
    Estudio aleatorizado del efecto del trasplante de células madre mononucleadas autólogas derivadas de la médula ósea mediante inyección directa intramiocárdica en asociación con revascularización quirúrgica convencional sobre el remodelado ventricular postinfarto de miocardio en fase subaguda.
    A.3.2Name or abbreviated title of the trial where available
    TECAM-QUIRÚRGICO
    A.4.1Sponsor's protocol code numberTECAM-QUIRÚRGICO
    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 SponsorFundación General de la Universidad de Valladolid
    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 nameCélulas Madre Mononucleadas derivadas de la Médula Ósea (CMMO)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntracardiac 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) 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 No
    D.3.11.8Extractive medicinal product No
    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
    Pacientes con Infarto Agudo de Miocardio con un máximo de 10 días de evolución.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028597
    E.1.2Term Myocardial infarction acute
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Demostrar que en los pacientes con IAM, sometidos a trasplante autólogo de CMMO en fase subaguda (entre 10 y 15 días desde el infarto) en asociación con cirugía de revascularización coronaria, se produce un aumento de la F.E., una disminución de los volúmenes ventriculares y una mejoría de la contractilidad en las regiones infartadas a los 9 meses de la cirugía superior a lo observado en pacientes sometidos al tratamiento de revascularización quirúrgica convencional habitual
    •Comparar los cambios en la F.E., los volúmenes ventriculares y la contractilidad en la región del infarto entre los pacientes que han sido sometidos a un trasplante autólogo de CMMO en fase subaguda (entre 10 y 15 días desde el infarto) en asociación con cirugía de revascularización coronaria, y los que han recibido tratamiento de revascularización quirúrgica convencional a los 9 meses de la cirugía.
    E.2.2Secondary objectives of the trial
    Demostrar mediante RMN que, a los 9 meses, el grosor del miocardio en el área infartada aumenta, en los pacientes que han recibido trasplante de CMMO en fase subaguda, más que en los pacientes del grupo control.
    Analizar las diferencias entre el grupo de tratamiento activo y el grupo control, respecto a la evolución al 9º mes del grosor del miocardio en el área infartada.
    Demostrar mediante RMN con realce tardío con Gadolinio que, a los 9 meses, la viabilidad miocárdica en el área infartada es mayor en los pacientes que han recibido el trasplante de CMMO, más que en los pacientes del grupo control.
    Analizar las diferencias entre el grupo que ha recibido el trasplante de CMMO y el grupo control, respecto a su impacto sobre la evolución al 9º mes de la viabilidad miocárdica en el área infartada.
    Comparar la incidencia de eventos cardíacos y totales cardíacos y no cardíacos entre el grupo que recibe trasplante de CMMO y el grupo control.
    Tipaje y selección de progenitores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Edad comprendida entre 30 y 80 años.
    •Infarto de miocardio previo, con un máximo de 10 días de evolución, con las siguientes características:
    -Curva enzimática típica de necrosis miocárdica.
    -Presencia de onda Q patológica (200 mseg, voltaje superior al 25% de la onda R en la misma derivación) en al menos 2 derivaciones el ECG de superficie correspondientes al área infartada.
    •Alteración en la motilidad en la región del infarto (detectada en ventriculografía en el cateterismo previo a la cirugía).
    •Indicación quirúrgica de revascularización coronaria sin realización previa de revascularización percutánea. Dicha indicación se realizará durante la primera sesión médico-quirúrgica posterior al cateterismo.
    •Fracción de eyección ventricular izquierda entre el 20 y 50%, determinada por ventriculografía.
    E.4Principal exclusion criteria
    •Clase clínica IV de la NYHA o Killip IV en el caso de infarto agudo de miocardio previa a la indicación quirúrgica.
    •Complicación mecánica del infarto.
    •Historia de taquicardia ventricular sostenida ó fibrilación ventricular posterior a las primeras 24 horas del infarto.
    •Portador de marcapasos o de desfibrilador cardíaco implantable
    •Cirugía cardiaca previa de cualquier tipo.
    •Tratamiento en las 4 semanas previas con cualquier fármaco en investigación.
    •Uso actual o potencial de drogas antineoplásicas.
    •Historia de cáncer en los últimos 5 años.
    •Uso actual ó potencial de drogas inmunosupresoras.
    •Tratamiento previo con revascularización transmiocárdica con Láser.
    •Mujeres en edad fértil a no ser que exista un test de embarazo negativo.
    •Cualquier enfermedad que puede afectar la supervivencia del paciente durante la duración del estudio.
    •Imposibilidad de retirada del tratamiento con anticoagulantes.
    •Insuficiencia renal previamente conocida con creatinina > 2,5 mg/dL.
    •No firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Aumento de la fracción de eyección, disminución de los volúmenes ventriculares y mejoría de la contractilidad en las regiones infartadas a los 9 meses de la cirugía
    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) 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
    Procedimiento habitual
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-11-05. Yes
    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 state22
    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 Decision2008-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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