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    Summary
    EudraCT Number:2006-005628-17
    Sponsor's Protocol Code Number:TCC0205
    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:2007-02-19
    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 number2006-005628-17
    A.3Full title of the trial
    Estudio abierto con evaluador ciego de la eficacia de las células mononucleares autólogas de médula ósea en la regeneración muscular y vascular en pacientes con disfunción ventricular izquierda tras infarto de miocardio / Open estudy with blind regulator on the effectiveness of autologous bone marrow mononuclear cells in patients with left ventricular dysfunction after myocardia infarction.
    A.4.1Sponsor's protocol code numberTCC0205
    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 SponsorGRUPO DE TERAPIA CELULAR Y CARDIOVASCULAR DEL HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS
    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 nameSUSPENSIÓN CELULAR DE CÉLULAS MONONUCLEARES DE MÉDULA ÓSEA
    D.3.2Product code BMCs
    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 IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCÉLULAS MONONUCLEARES DE MÉDULA ÓSEA
    D.3.9.2Current sponsor codeBMCs
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU/ml million colony forming units/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 30
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeCÉLULAS MONONUCLEARES AISLADAS A PARTIR DE MÉDULA ÓSEA. NO HAY EXPANSIÓN, SÓLO AISLAMIENTO.
    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
    TRATAMIENTO DE ENFERMEDAD CORONARIA (IAM Y DISFUNCIÓN VENTRICULAR IZQUIERDA / TREATMENTOF CORONARY DISEASE (AMI AND LEFT VENTRICULAR DYSFUNTION)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011099
    E.1.2Term Coronary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la mejoría de la función sistólica del ventrículo izquierdo tras el trasplante intracoronario de células mononucleares de médula ósea en pacientes con disfunción ventricular severa postinfarto, y compararlo con el grupo control.
    E.2.2Secondary objectives of the trial
    - Valorar la eficacia del implante intracoronario de células mononucleares de médula ósea en pacientes con disfunción ventricular severa postinfarto mediante la determinación de NT-proBNP y realización de ergometría con consumo de oxígeno. Comparar con grupo control.
    - Valorar la incidencia de eventos cardiovasculares y de ingresos hospitalarios y/o atenciones en urgencias (estancias < 24 horas).
    - Valorar la seguridad del implante intracoronario de células mononucleares de médula ósea mediante coronariografía de control a los 12 meses. Comparar con grupo control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Edad comprendida entre 18 y 75 años.
    • Antecedentes de infarto agudo de miocardio de localización anterior
    • Stent en DA de más de 6 meses de antigüedad y permeable
    • Disfunción ventricular severa (FEVI < 35%)
    • Tratamiento farmacológico a dosis óptimas
    • Aceptar su inclusión en el ensayo y firmar el consentimiento informado
    E.4Principal exclusion criteria
    • Pacientes menores de 18 años y mayores de 75 años
    • Mujeres físicamente fértiles que no deseen utilizar métodos anticonceptivos eficaces, embarazadas o lactantes.
    • Shock cardiogénico.
    • Reestenosis significativa del stent en DA (> 50%) o lesiones en otras arterias coronarias susceptibles de revascularización .
    • Síntomas de cualquier enfermedad mental significativa que, a juicio del investigador, pueda interferir en la capacidad de los pacientes para cumplir con el protocolo, Antecedentes de abuso de alcohol o drogas durante el año previo a la visita basal.
    • Pacientes con cualquier enfermedad maligna previa (durante los últimos 5 años) o presente, excepto carcinoma de células basales o escamosas extirpado.
    • Contraindicación para el aspirado de médula ósea (sólo grupo experimental).
    • Obtención de material celular insuficiente para la realización del implante (sólo grupo experimental).
    • Hallazgos anormales físicos de laboratorio clínicamente significativos durante las 2 semanas previas al inicio del estudio que pudiesen influir en los objetivos del estudio.
    • Incapacidad para cooperar o comunicarse con el investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal

    El objetivo principal es averiguar si en los pacientes con necrosis miocárdica establecida existen diferencias en el cambio porcentual en la fracción de eyección global y regional antes y después del tratamiento con células mononucleares de médula ósea mediante implante intracoronario y comparar los resultados con los obtenidos del grupo control.
    Este objetivo se evaluará comparando la función sistólica global y regional a los 12 meses después del trasplante de células mononucleares de médula ósea mediante ecocardiograma.

    Variables secundarias

    Constituyen variables secundarias de eficacia todas aquellas que registran datos clínicos y evolutivos de la disfunción ventricular: NT proBNP, ergometría con consumo de oxígeno, eventos cardiovasculares e ingresos.
    Constituyen variables secundarias de seguridad el registro de constantes vitales (TA, Fc), parámetros analíticos (hemograma, ionograma, función renal, bioquímica) y presencia de complicaciones relacionadas con los procedimientos del ensayo, para el grupo experimental (punción de cresta iliaca, cateterismos, se determinarán CPK y troponina a las 6 horas y a las 24 horas del implante intracoronario de células mononucleares de médula ósea), además del registro de acontecimientos adversos.
    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
    CON EVALUADOR CIEGO DE LA EFICACIA DE LAS BMCs AUTÓLOGAS EN LA REGENERACIÓN MUSCULAR Y VASCULAR
    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 HABITUAL PARA IAM Y DISFUNCIÓN VENTRICULAR IZQUIERDA
    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 Information not present in EudraCT
    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 Decision2008-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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