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    The EU Clinical Trials Register currently displays   37537   clinical trials with a EudraCT protocol, of which   6155   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-002329-30
    Sponsor's Protocol Code Number:CX501/TCEB
    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:2010-03-15
    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 number2005-002329-30
    A.3Full title of the trial
    ENSAYO CLINICO COMPARATIVO, ABIERTO, MULTICENTRICO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE UNA NUEVA TERAPIA CON PIEL QUIMÉRICA CULTIVADA PARA EL TRATAMIENTO DE LAS LESIONES CUTÁNEAS DE LOS PACIENTES CON EPIDERMOLISIS BULLOSA
    A.4.1Sponsor's protocol code numberCX501/TCEB
    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 SponsorCELLERIX, S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/369
    D.3 Description of the IMP
    D.3.2Product code CX501
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCx501
    D.3.10 Strength
    D.3.10.1Concentration unit DF dosage form
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    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
    Epidermolisis Bullosa distrófica recesiva con sindactilia cutánea severa
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10014989
    E.1.2Term Epidermolysis bullosa
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia del tratamiento mediante la aplicación local de parches de piel quimérica cultivada, frente a la utilización de un apósito oclusivo no adherente.
    Se valorará el efecto de los queratinocitos autólogos del paciente cultivados con fibroblastos alogénicos (procedentes de donante) sobre el tiempo y el resultado histológico de la epitelización en niños con lesiones cutáneas de epidermolisis bullosa distrófica recesiva en comparación con un apósito oclusivo no adherente.
    E.2.2Secondary objectives of the trial
    Evaluar la persistencia de colágeno VII en la piel quimérica.
    Evaluar la seguridad de la terapia celular con parches de piel quimérica cultivada, en comparación con la utilización de un apósito oclusivo no adherente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes de ambos sexos mayores de 28 días.
    Pacientes con Epidermolisis Bullosa Distrófica Recesiva, diagnosticada por criterios clínicos e histológicos, con sindactilia cutánea severa en los que esté indicada cirugía reconstructiva.
    Pacientes cuyos tutores legales hayan otorgado el consentimiento informado por escrito para la participación en el estudio previo a la realización de cualquier procedimiento descrito en el mismo.
    Pacientes con edad ≥ 12 años que hayan otorgado el consentimiento informado por escrito para la participación en el estudio previo a la realización de cualquier procedimiento descrito en el mismo.
    E.4Principal exclusion criteria
    Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces (anticoncepción oral).
    Mujeres embarazadas o en periodo de lactancia.
    Hipersensibilidad conocida ó sospechada a cualquier de los agentes terapéuticos incluidos en el estudio, incluidos fármacos anestésicos.
    Pacientes con antecedente de tumor maligno en los últimos 5 años.
    Pacientes con diagnóstico de tuberculosis activa en el momento de la inclusión.
    Pacientes con marcadores positivos previos para cualquiera de los siguientes patógenos: hepatitis B y C, VIH-1, VIH-2.
    Pacientes con historia de enfermedad hepática, gastrointestinal, hematológica, pulmonar o neurológica, no relacionada directamente con la Epidermolisis Bullosa, clínicamente relevante.
    Cualquier otra situación médica que a juicio del investigador pueda interferir con la participación óptima en el estudio o producir un riesgo significativo para el paciente.
    Alcoholismo, drogadicción, patología psiquiátrica u otros factores presentes en los tutores legales que a juicio del investigador puedan complicar la participación del paciente en el estudio.
    Pacientes que hayan participado en otro estudio en los 30 días previos o en los que se haya planeado su participación simultáneamente en otro estudio.
    Pacientes menores de edad, cuyos tutores legales no hayan otorgado el consentimiento informado para participar en el estudio.
    Pacientes ≥ 12 años que no hayan otorgado el consentimiento informado para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Días hasta llegar al 100% de epitelización del área afectada.
    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 Information not present in EudraCT
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    Apósito estéril Allevyn
    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 concerned3
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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 Decision2006-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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