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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-022988-35
    Sponsor's Protocol Code Number:FIBHGM-ECNC013-2010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-17
    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 number2010-022988-35
    A.3Full title of the trial
    TRATAMIENTO DE LA CISTITIS HEMORRÁGICA SEVERA POST-TRASPLANTE ALOGÉNICO CON CÉLULAS MESENQUIMALES
    A.4.1Sponsor's protocol code numberFIBHGM-ECNC013-2010
    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 para la Investigación Biomédica del Hospital Gregorio Marañón
    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 nameCELULAS MADRE MESENQUIMALES DE MEDULA OSEA
    D.3.2Product code CME
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1.000.000 U/ kg
    D.3.9.3Other descriptive nameCELULAS MADRE MESENQUIMALES DE MEDULA OSEA
    D.3.10 Strength
    D.3.10.1Concentration unit EID50 50% Embryo Infective Dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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
    Cistitis Hemorragica Servera Post-transplante
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10011793
    E.1.2Term Cistitis hemorrágica
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Evaluar la respuesta clínica (se considerará respuesta clínica completa a la desaparición de todos los síntomas) de la cistitis hemorrágica severa que no responde a tratamiento de soporte convencional tras infusión de CME, en dosis mínima de 1x106 CME/kg.
    - Evaluar la toxicidad de la infusión de CME, en términos de reacciones adversas, infecciones y afectación tóxica de órganos específicos. Se aplicarán las disposiciones sobre seguridad de la Ley del Medicamento 29/2006 y del R.D. 223/2004 sobre los Ensayos clínicos.
    E.2.2Secondary objectives of the trial
    - Evaluar la evolución clínica (supervivencia global, supervivencia libre de enfermedad, recaídas) de los pacientes con cistitis hemorrágica severa post-AloTPH tratados con CME
    - Evaluar dosis-respuesta.
    - Analizar el efecto inmunomodulador de las CME infundidas mediante estudio secuencial de poblaciones linfocitarias y su modificación en los patrones de secreción de citocinas y polarización de respuesta Th1/Th2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pacientes a los que se haya realizado un trasplante de progenitores hematopoyéticos alogénico en nuestro centro, que desarrollen cistitis hemorrágica severa (grados II a IV), persistente tras 5 días de tratamiento conservador habitual (hidratación forzada IV, lavados por sondaje vesical, levofloxacino y hemoderivados).
    -El tratamiento con CME estará siempre condicionado a la disponibilidad de al menos 1x106 CME/kg.
    - Consentimiento informado del paciente
    - Seguro de responsabilidad civil del paciente, suscrito por el promotor del ensayo, la Fundación para la Investigación Biomédica del HGUGM de Madrid
    E.4Principal exclusion criteria
    Descartadas otras posibles causas de cistitis hemorrágicas (cálculos, infecciones bacterianas o fúngicas, neoplasias).
    Grupo de donantes de médula ósea para generación de CME. Criterios de inclusión.
    - Donantes emparentados de aquellos pacientes a los que se vaya a realizar un TPH alogénico en nuestro centro con alto riesgo de desarrollar cistitis hemorrágica (acondicionamiento mieloablativo, donante no familiar o con disparidad HLA, presencia de EICH).
    - Consentimiento informado del donante.
    - Seguro de responsabilidad civil del donante, suscrito por el promotor del ensayo, la Fundación para la Investigación Biomédica del HGUGM de Madrid
    - Los donantes deben ser sanos y cumplir los requisitos para la donación de progenitores hemopoyéticos según el Real Decreto 1301/2006 sobre las normas de calidad y seguridad para la donación, la obtención, el procesamiento, la preservación, el almacenamiento y la distribución de células y tejidos humanos y sobre las normas de coordinación y funcionamiento para su uso en humanos.
    - Respecto al manejo de las CME criopreservadas se contemplarán las disposiciones del vigente R.D. 1301/2006 arriba mencionado.
    E.5 End points
    E.5.1Primary end point(s)
    Relacionadas con los pacientes:
    Fecha de nacimiento; Sexo; Diagnóstico y estado de la enfermedad al trasplante; Tipo de trasplante; Fecha de trasplante; esquema de acondicionamiento; profilaxis de EICH.
    Evolución post-TPH: Fecha prendimiento plaquetario (plaquetas >20.000/mm3 y plaquetas > 50.000/mm3) y neutrófilos (neutrófilos >500/mm3, neutrófilos >1000/mm3); fecha quimerismo completo en SP/MO; Complicaciones relevantes ocurridas hasta la infusión de CME; EICH: Fecha y grado de severidad, descripción de efectos adversos; Fecha último seguimiento, estado del paciente y de la enfermedad de base.
    Cistitis hemorrágica e infusión de CME: Monitorización de la función renal y características de la orina; Fecha aparición hematuria; grado clínico de la misma, días de duración de la hematuria, tratamiento concomitante realizado, dosis y duración; dosis de CME infundida y fechas de infusión; días hasta respuesta clínica y máximo grado de respuesta; Quimerismo de las CME en médula ósea post-infusión; Poblaciones linfocitarias, patrón de secreción de citocinas y polarización de respuesta Th1/Th2 tras la infusión ; Efectos adversos: Fecha y gradación.
    Donación y generación de CME: Fecha de nacimiento y sexo del donante; parentesco donante-receptor; Volumen de médula ósea extraído; células mononucleadas obtenidas; número de resiembras para obtener la dosis suficiente de CME; número de CME obtenidas al final del proceso.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 Decision2011-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-07-31
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