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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2010-022909-18
    Sponsor's Protocol Code Number:COT-CPMO-3
    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:2010-11-15
    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 number2010-022909-18
    A.3Full title of the trial
    Ensayo clínico Fase II para evaluar la eficacia y seguridad de la aplicación de Células Progenitoras de Médula Ósea Autóloga expandidas en el tratamiento quirúrgico de pseudoartrosis no hipertróficas de fémur, tibia y húmero, tras un primer fracaso terapéutico.
    A.4.1Sponsor's protocol code numberCOT-CPMO-3
    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 SponsorHospital General de L’Hospitalet
    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-ALPHA, Calcibón&#61650;Granules, Tissucol&#61650;Baxter
    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 IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXCEL-M-ALPHA
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40000000 to 50000000
    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
    Pseudoartrosis no hipertróficas de fémur, tibia y húmero, tras un primer fracaso terapéutico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10017088
    E.1.2Term Fractura no consolidada
    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 eficacia y seguridad de la aplicación de células madre mesenquimales de médula ósea autóloga expandidas exvivo (XCEL-M-ALPHA) e incorporadas en una matriz sintética de trifosfato cálcico en el tratamiento de la pseudoartrosis no hipertrófica de fémur, húmero o tibia tras un primer fracaso terapéutico.
    E.2.2Secondary objectives of the trial
    1. Estimar el porcentaje de respuestas completas a los 12 meses de la intervención tras la aplicación de las células madre mesenquimales de médula ósea autóloga (XCEL-M-ALPHA) en el tratamiento de la pseudoartrosis no hipertrófica de fémur, húmero o tibia.
    2. Estimar el porcentaje de pacientes que requieren un segundo procedimiento quirúrgico por falta de respuesta tras los primeros 12 meses después de la intervención.
    3. Estimar el tiempo transcurrido hasta la obtención de una respuesta completa tras la intervención.
    4. Evaluar el número y tipo de complicaciones, tanto las relacionadas con la obtención del aspirado medular como las intra y postquirúrgicas.
    5. Evaluar la seguridad a 3 años de la aplicación de las células madre mesenquimales de médula ósea autóloga (XCEL-M-ALPHA).
    6. Describir los posibles cambios, antes y después del tratamiento, en la calidad de vida y la actividad laboral de los pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes mayores de 18 años que presenten pseudoartrosis no hipertrófica de fémur, tibia o húmero confirmada radiográficamente. Para el diagnóstico radiográfico se requerirán proyecciones de frente, perfil y oblicuas, y se aplicarán los criterios de Weber (Weber BG, 1986.), debiéndose cumplir las siguientes condiciones:
    - que, entre los fragmentos, no se evidencien puentes óseos suficientes para estabilizar el foco de fractura,
    - y que, además, no se observe suficiente actividad biológica regenerativa del tejido óseo.
    2. Falta de respuesta a un tratamiento quirúrgico previo con cualquiera de las técnicas habituales (osteosíntesis u osteotaxis, más injerto de hueso esponjoso autólogo, homólogo o biomateriales).
    3. Obtención del consentimiento informado por escrito del paciente.
    E.4Principal exclusion criteria
    1.Infección presente en el foco de fractura, diagnosticada mediante al menos uno de los siguientes signos y síntomas: inflamación, dolor, cultivo positivo, analítica sugestiva de infección o gammagrafía positiva.
    2. Pacientes con HIV, Hepatitis, Lúes.
    3. Mujeres embarazadas o en periodo de lactancia.
    4. Enfermedad neoplásica activa o paciente oncológico con un período libre de enfermedad inferior a 5 años.
    5. Estados inmunodepresivos.
    6. Enfermedades congénitas óseas (hipofosfatemia), enfermedad metabólica ósea asociada con hipoparatiroidismo primario o secundario.
    7. Insuficiencia renal crónica.
    8. 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.
    9. Intervención quirúrgica en los 30 días previos a la inclusión.
    10. Pacientes cuya comorbilidad desaconseje el tratamiento clásico con autoinjerto de cresta iliaca.
    11. Pacientes que por patología psiquiátrica grave, adicción a sustancias o lugar de residencia no garanticen el adecuado seguimiento a lo largo de todo el periodo de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Se considerará como la variable principal para evaluar la eficacia del tratamiento la respuesta obtenida a los 12 meses desde la intervención, evaluada radiológicamente y de forma independiente por al menos dos observadores aplicando los criterios de Hammer, Hammerby and Lindholm (Hammer, 1985). Se definirá una respuesta completa cuando, tras la evaluación de las distintas proyecciones radiológicas (AP, lateral, angulación 45º, oblicuas), tanto el cirujano responsable como el evaluador externo decidan que el grado de curación corresponde a un grado 1 ó 2. En caso de discrepancia de ambos observadores, se recurrirá a un tercer evaluador.
    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 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 years4
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-15. Yes
    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 state32
    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 Decision2011-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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