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    Summary
    EudraCT Number:2009-016449-24
    Sponsor's Protocol Code Number:XCEL-M-09-01
    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:2010-01-29
    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 number2009-016449-24
    A.3Full title of the trial
    Regeneración del cartílago articular en gonartrosis de IIº y IIIer grados mediante infiltración articular de Xcel-m-condro-alfa*

    *Células progenitoras mesenquimales de médula ósea autóloga, expandidas 'Ex Vivo' con procedimiento GMP de XCELIA- División Terapias Avanzadas del Banc de Sang i Teixits
    A.4.1Sponsor's protocol code numberXCEL-M-09-01
    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 SponsorBanc de Sang i Teixits (BST)
    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 nameXcel-m-condro-alfa
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSC
    D.3.10 Strength
    D.3.10.1Concentration unit EID50 50% Embryo Infective Dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number38000000 to 42000000
    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
    Gonartrosis grados II y III de Kellgren y Lawrence
    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
    Evaluar la viabilidad y la seguridad del producto Xcel-m-condro-alfa al aplicarse por inyección percutánea en la articulación de la rodilla como tratamiento de la degeneración artrosis, comprobando que es realizable cada uno de los procedimientos establecidos en el protocolo y registrando los posibles efectos adversos relacionados con la terapia celular y acontecimientos adversos surgidos durante el periodo del ensayo clínico ya sean o no relacionados con el mismo.
    E.2.2Secondary objectives of the trial
    Determinar los resultados clínicos y las variaciones de las imágenes RNM que denoten antiinflamación, regeneración o por el contrario progresión del proceso artrósico, después de 12 meses de haberse efectuado la implantación de Xcel-m-condro-alfa en la articulación afecta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Gonartrosis grado II o III de Kellgren y Lawrence valorada por dos observadores.

    2. Rodilla dolorosa crónica de características mecánicas.

    3. Ausencia de proceso séptico local o sistémico.

    4. Análisis hematológicas y bioquímicas sin alteraciones significativas que contraindiquen el tratamiento.

    5. Consentimiento Informado por escrito del paciente.

    6. El paciente es capaz de entender la naturaleza del estudio.
    E.4Principal exclusion criteria
    1. Paciente < 18 años, o legalmente dependiente

    2. Paciente > 65 años

    3. Intervención previa en rodilla afectada

    4. Tratamiento intraarticular en los últimos 6 meses.

    5. Rotura ligamentosa o meniscal visualizada en imagen de RNM

    6. Infección presente (para incluirse en el estudio no debe evidenciarse ningún signo infeccioso).

    7. Pacientes que presenten serología positiva frente a HIV, Hepatitis y Lúes.
    (Dependiendo de la historia clínica del paciente se realizarán test adicionales que pueden incluir: Trypanosoma cruzi, toxoplasma, EBV, CMV, malaria, HLA, Rhd.
    La obtención de un positivo en cualquiera de los tests anteriormente citados, con excepción de CMV y toxoplasma, implicará la exclusión del paciente del ensayo clínico. Se considera que al tratarse de una terapia orientada a pacientes de patologías traumatológicas no está justificada, en las etapas iniciales de evaluación de la terapia, la inclusión de este tipo de pacientes teniendo en cuenta los riesgos asociados).

    8. Enfermedades congénitas o evolutivas que traduzcan malformación y/o deformaciones significativas de la rodilla y condicionen dificultades de aplicación y de evaluación de los resultados.

    9. Sobrecarga ponderal expresada en índice de masa corporal (IMC) superior a 30,5 (obesidad grado II). Siendo IMC= masa (Kg): (altura (m))2

    10. Mujeres embarazadas o que pretenden estarlo o en periodo de lactancia

    11. Enfermedad neoplásica

    12. Estados inmunodepresivos

    13. Participación simultánea en otro ensayo clínico o tratamiento con otro producto en fase de Investigación en los 30 días previos a la inclusión en el estudio.

    14. Otras patologías o circunstancias que comprometan la participación en el estudio según criterio médico
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo es la evaluación de la eficacia mediante criterios clínicos, radiográficos y de RNM a los 6 y 12 meses de la implantación de Xcel-m-condro-alfa.
    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 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 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 months6
    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 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 state15
    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 Decision2010-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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