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    Summary
    EudraCT Number:2012-000734-19
    Sponsor's Protocol Code Number:XCEL-MS-02
    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:2014-01-10
    Trial results View 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 number2012-000734-19
    A.3Full title of the trial
    Treatment of autologous mesenchymal stem cells derived from bone marrow as a potential therapeutic strategy for the treatment of multiple sclerosis
    Tratamiento con Células Troncales Mesenquimales Autólogas Derivadas de Médula Ósea como Estrategia Terapéutica Potencial en la Esclerosis Múltiple
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bone marrow cell treatment as treatment of multiple sclerosis
    Células de médula ósea para el tratamiento de la esclerosis múltiple
    A.3.2Name or abbreviated title of the trial where available
    EMMES
    EMMES
    A.4.1Sponsor's protocol code numberXCEL-MS-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBanc de Sang i Teixits
    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 supportMSSSI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanc de Sang i Teixits
    B.5.2Functional name of contact pointRuth Coll
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Taulat, 116
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08005
    B.5.3.4CountrySpain
    B.5.4Telephone number3493557 35 00
    B.5.5Fax number3493557 35 03
    B.5.6E-mailrucoll@bst.cat
    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-MC-ALPHA
    D.3.2Product code XCEL-MC-ALPHA
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNAutologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved
    D.3.9.3Other descriptive nameMesenchymal Stem Cells
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800000 to 1200000
    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) Yes
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis
    Esclerosis múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    Esclerosis múltiple
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1 - To evaluate the safety and tolerability of XCEL-MC-ALPHA by:
    a. Overall incidence of adverse events by treatment
    b. Incidence of adverse events by organ system preferred term, by treatment.
    c. Severity of adverse events per treatment.
    d. Intensity of adverse events per treatment.
    e. Causation by treatment.
    Evaluar la seguridad y tolerabilidad de XCEL-MC-ALPHA mediante:
    a. Incidencia de acontecimientos adversos globales, por tratamiento
    b. Incidencia de acontecimientos adversos por órganos y sistemas según término preferente, por tratamiento.
    c. Gravedad de los acontecimientos adversos, por tratamiento.
    d. Intensidad de los acontecimientos adversos, por tratamiento.
    e. Relación de causalidad, por tratamiento.
    E.2.2Secondary objectives of the trial
    Assess the effectiveness of XCEL-MC-ALPHA determined by the cumulative number of lesions that enhance with gadolinium T1 in sequence magnetic resonance in both treatment periods, in the group
    initially assigned to placebo and the group initially assigned to XCEL-MC-ALPHA
    Evaluar la eficacia de XCEL-MC-ALPHA mediante el número acumulado de lesiones que se realzan con gadolinio en la secuencia T1 en ambos periodos de tratamiento, en el grupo
    asignado inicialmente a placebo y en el grupo asignado inicialmente a XCEL-MC-ALPHA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with MS (McDonald 2010)
    Clinical course of patients with relapsing-remitting MS or secondary progressive (Lublin and Reingold 1996)
    Age between 18 and 60
    Patients in whom is not indicated or are not in a position to begin treatment with drugs that modify disease available for MS, after the researcher has been informed of their benefits and potential adverse events, or who do not respond adequately to standard therapy or can not tolerate
    EDSS < o = 6.5
    At least nine T2 lesions
    Active MS, defined by: At least one outbreak in the last year or At least one Gd-enhancing lesion in the last 6 months
    Have signed the informed consent for participation in the stud
    Pacientes con EM (McDonald 2010)
    Pacientes con curso clínico de la EM Recurrente-Remitente o Secundariamente Progresivo (Lublin y Reingold 1996)
    Edad entre 18 y 60 años
    Pacientes en los que no esté indicado o no deseen iniciar tratamiento con fármacos modificadores de la enfermedad disponibles para la EM, después de que el investigador les
    haya informado de sus beneficios respectivos y de los posibles acontecimientos adversos, o que no responden adecuadamente al tratamiento habitual o no lo toleran.
    EDSS < o = 6.5
    Al menos nueve lesiones en T2
    EM activa, definida por: Al menos un brote en el último año, o Al menos una lesión realzada con Gd en los últimos 6 meses
    Haber firmado el consentimiento informado de participación en el estudio.
    E.4Principal exclusion criteria
    Patients pre-treated with:
    - Interferon beta or glatiramer acetate 3 months prior to screening
    - Natalizumab or fingolimod in the 6 months prior to screening
    - Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
    - Experimental treatment within 3 months prior to screening
    MS attack in the 4 weeks prior to randomization
    Serum creatinine> 2.0 mg / dl. If serum creatinine is> 1.2 mg / dl, measure glomerular filtration rate. Patients were excluded if the filtrate is <60 ml/minuto/1, 73 m2
    Infectious disease active or uncontrolled
    Fertile patients who are not using a suitable method of contraception (at the discretion of the investigator). If the patient is postmenopausal or sterile must be documented in the medical record.
    Tratamiento previo con:
    - Interferón beta o acetato de glatiramer en los 3 meses previos a la selección
    - Natalizumab o fingolimod en los 6 meses previos a la selección
    - Mitoxantrona, ciclofosfamida u otro tratamiento inmunosupresor en cualquier momento
    Tratamiento experimental en los 3 meses previos a la selección
    Brote de EM en las 4 semanas anteriores a la aleatorización
    Creatinina sérica > 2.0 mg/dl. Si la creatinina sérica es > 1.2 mg/dl, se debe medir el filtrado glomerular. Los pacientes se excluirán si el filtrado es <60 ml/minuto/1,73 m2
    Enfermedad infecciosa activa o no controlada
    Pacientes fértiles que no estén utilizando un método adecuado de anticoncepción (a criterio del investigador). Si la paciente es menopáusica o estéril debe estar documentado en la historia clínica.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability
    Seguridad y tolerabilidad
    E.5.1.1Timepoint(s) of evaluation of this end point
    4, 12, 24, 28, 36 and 48th weeks
    4, 12, 24, 28, 36 y 48 semanas
    E.5.2Secondary end point(s)
    Lesions that enhance with gadolinium T1 in sequence magnetic resonance
    Lesiones que se realzan con Gd en la RM
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 12, 24, 28, 36 and 48th weeks
    4, 12, 24, 28, 36 y 48 semanas
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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.
    Última visita del último sujeto incluido en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state8
    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)
    Expected normal treatment of that condition
    Tratamiento usual para la enfermedad
    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 Decision2014-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-25
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