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    Summary
    EudraCT Number:2007-000339-24
    Sponsor's Protocol Code Number:APOLLO_01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-02
    Trial results Removed from public view
    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 number2007-000339-24
    A.3Full title of the trial
    “Ensayo clínico aleatorizado de células madre provenientes de tejido adiposo en el tratamiento de pacientes con infarto de miocardio de ST elevado: el ensayo APOLLO”
    A.3.2Name or abbreviated title of the trial where available
    Apollo
    A.4.1Sponsor's protocol code numberAPOLLO_01
    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 SponsorCytori Therapeutics, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 namecelulas regenerativas del tejido adiposo
    D.3.2Product code ADRCs
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntracardiac use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pacientes con infarto de miocardio de ST elevado
    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
    Determinar la seguridad y factibilidad de células madre provenientes de tejido adiposo y colocadas por vía intracoronaria (IC) en el tratamiento de pacientes con infarto de miocardio de ST elevado (STEMI).
    E.2.2Secondary objectives of the trial
    Se analizara tras 12,18,24 y 36 meses de tratamiento la función ventricular izquierda
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Capaces de proporcionar un consentimiento informado.
    ·Hombres o mujeres de 20 a 85 años de edad, inclusive.
    ·Síntomas clínicos concordantes con un AMI (dolor, etc.) con un intervalo de 2 a 12 horas desde la aparición de síntomas y la PCI, y que no responden a la nitroglicerina.
    ·AMI
    ·Revascularización de la lesión involucrada en el vaso epicárdico principal dentro de las 12 horas de la aparición de síntomas de AMI (definida como (1) PCI primaria o facilitada con implante stent, que produce un flujo TIMI 3 y (2) estenosis residual no superior al 10% por evaluación visual o no superior al 20% por angiografía coronaria cuantitativa en línea)
    ·Zona de hipocinesia o acinesia que corresponde a la lesión involucrada, determinada por ventriculograma izquierdo en el momento de la PCI primaria
    ·Fracción de eyección del ventrículo izquierdo (LVEF) ³30% y £50%; determinada por angiografía del ventrículo izquierdo después de PCI. Se puede evaluar la LVEF por ecocardiografía si no se puede analizar o no se dispone del angiograma ventricular izquierdo.
    ·Capacidad de someterse a una lipoaspiración.
    ·Prueba negativa de embarazo, en orina (solamente mujeres).
    E.4Principal exclusion criteria
    ·MI previo, cardiomiopatía conocida previa o ingreso hospitalario previo por insuficiencia cardíaca congestiva (CHF)
    ·Más de 24 horas después de PCI aguda
    ·Patología importante de las válvulas
    ·Más de 12 horas o menos de 2 horas entre los primeros síntomas de AMI y la revascularización, definida como la recuperación de flujo de por lo menos TIMI 3
    ·Imposibilidad de completar la infusión de ADRC dentro de las 24 horas de la PCI
    ·Tratamiento programado de la patología de las coronarias, o algún otro procedimiento de intervención o cirugía para tratar la cardiopatía (por ejemplo, reemplazo de válvula, PCI o CABG) planificados o programados dentro de 6 meses después del procedimiento del estudio
    ·Necesidad de ventilación mecánica
    ·Choque cardiogénico
    ·Inestabilidad hemodinámica dentro de las 24 horas anteriores a la aleatorización, definida por la presencia de cualquiera de los siguientes problemas:
    ·Necesidad de apoyo inotrópico
    ·presión arterial sistólica <90 mm Hg
    ·Frecuencia cardíaca >100 lpm durante más de 1 hora
    ·Fibrilación ventricular previa, o taquicardia ventricular sostenida
    ·Fibrilación auricular persistente
    ·Neoplasia
    ·Enfermedad infecciosa aguda o crónica por bacterias o virus
    ·Marcapasos, desfibrilador automático implantado (ICD) o cualquier otra contraindicación para MRI
    ·LVEF <30% o >50% por angiografía del ventrículo izquierdo en el momento de la PCI primaria
    ·Enfermedad pulmonar obstructiva crónica (COPD) moderada o grave (consulte el Apéndice 16 para ver los códigos de clasificación)
    ·Mujeres embarazadas o que estén dando pecho
    ·Alergias o sensibilidades conocidas y pertinentes
    ·Creatinina sérica >2.0 mg/dL
    ·Participación en cualquier otro estudio de investigación clínica que no ha alcanzado su criterio de valoración primario de la eficacia o que de alguna otra forma interferiría con la participación del paciente en este estudio
    ·Expectativa de vida <1 año
    ·Cualquier enfermedad o condición concurrente que a criterio del investigador significaría que el paciente no es apto para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Los criterios de valoración de la seguridad se evaluarán después del procedimiento a los 30 días, y luego a los 3, 6, 12, 18, 24 y 36 meses después del procedimiento:
    ·Incidencia de acontecimientos adversos importantes cardíacos o cerebrales (MACCE)·Incidencia de acontecimientos adversos graves (SAE) / acontecimientos adversos (AE)
    ·Criterio de valoración clínico compuesto: muerte, MI, ataque cerebrovascular
    ·Nueva hospitalización debido a insuficiencia cardíaca
    ·Angina de pecho según la define la Canadian Cardiovascular Society (CCS) y clasificaciones de Braunwald
    ·Clase según la New York Heart Association (NYHA)
    ·Monitorización electrocardiográfica durante 6 días después del procedimiento de inyección de células (continua), seguida de la monitorización semanal durante las cuatro semanas iniciales (durante 48 horas) y a los 2 , 3, 4 , 6, 12 y 18 meses (durante 24 horas).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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
    Los criterios de valoración primaria para todos los pacientes inscritos en este ensayo se evaluarán a los 6 meses después del procedimiento; sin embargo, el estudio también incluye un período de seguimiento a largo plazo de hasta 36 meses después del procedimiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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 Information not present in EudraCT
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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 Decision2007-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-19
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