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    The EU Clinical Trials Register currently displays   44189   clinical trials with a EudraCT protocol, of which   7329   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:2007-007956-33
    Sponsor's Protocol Code Number:RESTORE-2
    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:2008-02-04
    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 number2007-007956-33
    A.3Full title of the trial
    A clinical evaluation of adipose derived Regenerative cells in the treatment of patients with brEast deformities post Segmental breast resection (lumpectomy) with Or without Radiation therapy. A phase IV post market study – the RESTORE 2 trial

    Evaluación clínica de células regenerativas derivadas de tejido adiposo para el tratamiento de pacientes con deformidades mamarias tras mastectomia segmentaria (cuadrantectomia) con o sin radioterapia. Un ensayo fase IV de farmacovigilancia – Ensayo RESTORE -2
    A.3.2Name or abbreviated title of the trial where available
    RESTORE-2
    A.4.1Sponsor's protocol code numberRESTORE-2
    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 nameAdipose Derived Regenerative Cells
    D.3.2Product code ADRC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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 deformidades mamarias tras mastectomía segmentaria (cuadrantectomía) con o sin radioterapia
    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
    Estudio de fase IV, de farmacovigilancia para evaluar el transplante de tejido adiposo autólogo con adición de células regenerativas derivadas de tejido adiposo (CRDTA) en pacientes con deformidades mamarias funcionales y cosméticas tras mastectomía segmentaria o cuadrantectomía, obtener coste-efectividad y calidad de vida dentro de los estados miembros de la EU.
    E.2.2Secondary objectives of the trial
    Obtener datos de satisfacion tanto del paciente como del medico tras el resultado del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Las pacientes se incorporarán al estudio sólo si cumplen TODOS los criterios siguientes (por mama, si corresponde):
    · Capaz de otorgar el consentimiento informado por escrito
    · Mujer
    · 18 a 75 años de edad
    · Si es fértil, prueba de embarazo en orina negativa
    · No es fértil (sometida a esterilización quirúrgica o posmenopáusica) o utiliza métodos anticonceptivos adecuados (anticonceptivos hormonales aprobados, como la píldora [si el investigador lo permite], métodos de barrera [como preservativo o diafragma usados con espermicida], o un dispositivo intrauterino [DIU])
    · Antecedentes de carcinoma mamario T2N0M0
    o Tumor ≤3 cm en su dimensión mayor
    o Mastectomía segmentaria o cuadrantectomía quirúrgica o endoscópica
    o Márgenes quirúrgicos limpios
    o Sin prótesis en las mamas que van a someterse al tratamiento
    · Capacidad de someterse a lipoaspiración
    · Último tratamiento contra el cáncer ≥12 meses antes del reclutamiento y ausencia de recidiva
    · Sin signos de recidiva del cáncer en la mamografía, la RMN (resonancia magnética nuclear) y la exploración mamaria antes del reclutamiento
    · Signos objetivos de lesiones mamarias importantes tras tratamiento de conservación mamaria (p. ej., cicatrices, deformidades)
    · Clasificación de secuelas cosméticas Tipo I
    · Se dispone de al menos 1 cm de tejido blando (p. ej., mama o tejido adiposo) entre la piel y la pared torácica en el lado receptor
    · Persisten al menos dos terceras partes de la mama después del tratamiento de conservación mamaria
    · No hay adherencias continuas de la piel al hueso >3 cm de diámetro
    · El volumen y forma de los defectos deben poder corregirse durante una sola sesión de tratamiento (volumen máximo del defecto ≤ 150 ml en la mama o mamas que se someterán al tratamiento)
    E.4Principal exclusion criteria
    Las participantes se incorporarán al estudio sólo si no cumplen NINGUNO de los siguientes criterios (por mama, si procede):
    · Trastorno autoinmunitario (p ej., lupus eritematoso sistémico [LES])
    · Antecedentes de enfermedades cutáneas atróficas, metabólicas o del tejido conectivo
    · Antecedentes de cicatrización queloidea
    · Uso crónico (>7 días consecutivos) de anticoagulantes (como ácido acetilsalicílico) o antiinflamatorios no esteroideos (AINE) en los 15 días anteriores al reclutamiento
    · Esperanza de vida ≤ 2 años
    · Recidiva o tumor maligno activo que exigió radioterapia o cirugía ≤12 meses antes del reclutamiento
    · Presencia de cualquier otro tumor maligno conocido
    · Índice de masa corporal (IMC) >30
    · Planear someterse a cirugía de adelgazamiento o prever variaciones significativas de peso durante el estudio (definidas como cambios en el IMC >5 en comparación con la situación inicial)
    · Enfermedades infecciosas agudas o crónicas, incluidas, entre otras, la infección por el virus de la inmunodeficiencia humana (VIH), la hepatitis B y la hepatitis C
    · Embarazo o lactancia
    · Alergias o sensibilidades de interés conocidas
    · Participación en cualquier otro estudio de investigación clínica que no ha alcanzado su criterio de valoración principal o que interferiría de algún otro modo la participación de la paciente en este estudio
    · Anterior participación en este estudio
    · Cualquier comorbilidad que, en opinión del investigador, haría que la paciente no fuera adecuada para participar en el estudio
    · Presencia de contraindicaciones para la RMN
    E.5 End points
    E.5.1Primary end point(s)
    Criterios de valoracion principales
    Satisfacción de la paciente con los resultados cosméticos y funcionales
    · Satisfacción del médico con los resultados cosméticos y funcionales
    · Mejoría en la deformidad mamaria general, evaluada por el médico y la paciente por separado, a los 12 meses en comparación con la visita basal

    Criterios de valoracion secundarios
    · Mejoría de las anomalías de la pigmentación cutánea, evaluadas por el médico y la paciente por separado, a los 6 y 12 meses en comparación con la situación inicial
    · Mejoría de la deformidad mamaria general, evaluada por el médico y la paciente por separado, a los 6 meses en comparación con la situación inicial
    · Acontecimientos adversos en todas las pacientes de la población por intención de tratar (IT) (por paciente)
    · Número de tratamientos necesarios para lograr cambios positivos en determinados criterios de valoración, como la satisfacción de la paciente y del médico
    · Mejoría de la puntuación de calidad de vida de la paciente (por paciente)
    · Número de tratamientos necesarios para reducir la puntuación de la escala LENT-SOMA
    · Datos de rentabilidad y utilización de recursos (por paciente)
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    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 Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 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 No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Patients will continue to receive standard follow up care with their physician and/or Oncologist.
    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 Decision2008-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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