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    Summary
    EudraCT Number:2011-006270-13
    Sponsor's Protocol Code Number:XCEL-MEN-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:2012-08-23
    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 number2011-006270-13
    A.3Full title of the trial
    A phase I-IIa safety and efficacy pilot clinical trial of intraarticular administration of autologous mesenchymal stem cells in meniscus injury
    Estudio clínico piloto de fase I-IIa de seguridad y eficacia en la reparación de la lesión de menisco mediante infiltración intraarticular de células mesenquimales autólogas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial using intraarticular administration of stem cells in meniscus injury
    Estudio clinico sobre el uso de celulas madre intraarticulares en la lesión de menisco
    A.4.1Sponsor's protocol code numberXCEL-MEN-01
    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 supportMinisterio de Sanidad, Servicios Sociales e Igualdad
    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 number+34935573500
    B.5.5Fax number+34935573500
    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-M-ALPHA
    D.3.2Product code XCEL-M-ALPHA
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNCélulas mesenquimales autólogas
    D.3.9.2Current sponsor codeXCEL-M-ALPHA
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30000000 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) 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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Degenerative meniscal lesion
    Lesión degenerativa de menisco
    E.1.1.1Medical condition in easily understood language
    Degenerative meniscal lesion
    Lesión degenerativa de menisco
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10069364
    E.1.2Term Meniscal degeneration
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA by VAS for pain at 12 month follow-up.
    - Evaluar la eficacia de la infiltración intraarticular de XCEL-M-ALPHA objetivada por EVA del dolor a los 12 meses de seguimiento
    E.2.2Secondary objectives of the trial
    - To assess the safety of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury.
    - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury by RM 1.5 Tesla at 6 and 12 month follow-up.
    - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in cartilage injuries associated to degenerative meniscus injury by dGEMRIC and T2 mapping at 6 and 12 month follow-up.
    - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA by VAS for pain at 1, 3 and 6 month follow-up.
    - To assess the efficacy of intraarticular administration of XCEL-M-ALPHA in degenerative meniscus injury by IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up.
    - Evaluar la seguridad de la infiltración intraarticular de XCEL-M-ALPHA en la lesión degenerativa de menisco.
    - Evaluar la eficacia de la infiltración de XCEL-M-ALPHA en la lesión degenerativa de menisco mediante cambios en la imagen por RM de 1.5 Tesla a los 6 y 12 meses de seguimiento.
    - Evaluación cualitativa y cuantitativa de la infiltración de XCEL-M-ALPHA en la lesión del cartílago articular asociada a la lesión degenerativa de menisco mediante dGEMRIC y T2 mapping a los 6 y 12 meses de seguimiento.
    - Evaluar la eficacia de la infiltración intraarticular de XCEL-M-ALPHA objetivada por EVA del dolor a los 1, 3 y 6 meses de seguimiento.
    - Evaluar la eficacia de la infiltración de XCEL-M-ALPHA en la lesión degenerativa de menisco mediante criterios de evolución clínica objetivada por los tests de funcionalidad IKDC, KOOS y Lysholm y calidad de vida por el cuestionario SF-36, a los 3, 6 y 12 meses de seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient between 40 and 60 years of age
    2. Degenerative meniscus infjury grade 3 (Crues et al.)
    3. Indication of conservative treatment
    4. Normal alignment of the knee (between 3º varus and 10 º valgus)
    5.Patient is able to follow a rehabilitation program
    6. Informed consent given by the patient in writing
    7. Patient is able to understant the trial.
    1. Pacientes de 40 a 60 años de edad.
    2. Lesión degenerativa de menisco grado 3 según la escala de Crues et al.
    3. Tratamiento conservador indicado.
    4. Alineación normal de la rodilla (entre 3º de varo y 10ª de valgo).
    5. Paciente capaz de seguir tratamiento de rehabilitación.
    6. Consentimiento Informado por escrito del paciente.
    7. El paciente es capaz de entender la naturaleza del estudio.
    E.4Principal exclusion criteria
    1. Traumatic meniscus injury
    2. Surgical intervention to the affected knee
    3. Local or systemic infection
    4. Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
    5. Significant abnormal laboratory tests that contraindicates participation in the trial.
    6. Pregnant women or intend to become pregnant or breast-feeding
    7. The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
    8. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
    9. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
    1. Lesión de menisco de etiología traumática.
    2. Intervención quirúrgica en la rodilla afectada.
    3. Proceso séptico local o sistémico.
    4. Infiltración de corticoides o ácido hialurónico en los 3 últimos meses en la rodilla afectada.
    5. Análisis hematológicos y bioquímicos con alteraciones significativas que contraindiquen la participación en el estudio.
    6. Mujeres embarazadas o que pretenden estarlo en los siguientes 12 meses a la firma del consentimiento informado y mujeres en periodo de lactancia.
    7. Portador de marcapasos, alergia al contraste, insuficiencia renal severa o cualquier otra contraindicación para realizar RM con contraste.
    8. Otras patologías o circunstancias que puedan comprometer la participación del paciente en el estudio según criterio médico.
    9. Negación del paciente a ser seguido por un periodo que excede el ensayo clínico en sí.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in pain score by VAS at 12 months follow up
    Cambios en la escala de dolor mediante VAS a los 12 meses de seguimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months follow-up
    A los 12 meses de seguimiento
    E.5.2Secondary end point(s)
    - Safety: physical examination, vital signs, laboratory values and adverse events.
    -Imaging:
    - Qualitative and quantitative changes of the meniscus by magnetic resonance imaging 1.5 Tesla at 6 and 12 months.
    - Qualitative and quantitative changes in articular cartilage by T1 and T2 mapping at 6 and 12 months
    - Changes in pain score by VAS at 1, 3 and 6 months.
    - Changes in IKDC, KOOS and Lysholm tests at 3, 6, and 12 months.
    - Quality of life: changes in SF-36 at 3, 6, and 12 monts.
    - Histology in the event of knee surgery.
    - Seguridad: Exploración física, constantes vitales, resultados analíticos (bioquímica, hematología) y acontecimientos adversos.
    - Imagen:
    - Cambios cualitativos y cuantitativos del menisco por RM de 1.5 Tesla a los 6 y 12 meses.
    - Cambios cualitativos y cuantitativos en la intensidad de señal del cartílago articular mediante T1 y T2 mapping a los 6 y 12 meses
    - Cambios en la escala de dolor mediante EVA a los 1, 3 y 6 meses.
    - Cambios en los tests IKDC, KOOS y Lysholm a los 3, 6, y 12 meses.
    - Calidad de vida: cambios en el test de calidad de vida SF-36 a los 3, 6, y 12 meses.
    - Histología en caso de intervención quirúrgica de rodilla.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 months follow-up
    A los 12 meses de seguimiento
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Exploratory pilot study
    Estudio piloto exploratorio
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    El grupo control sigue tratamiento conservador basado en rehabilitación
    The control group follows conservative therapy based on rehabilitation
    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
    LVLS
    Ultima visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 20
    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 state20
    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)
    Patients who have been treated with XCEL-M-ALPHA should be followed up for at least 5 years to collect additional safety and efficacy data.
    Los pacientes que hayan sido infiltrados con XCEL-M-ALPHA deberán seguir un control específico hasta completar, al menos, los 5 años siguientes a la infiltración en los que se les seguirá de forma individualizada para obtener datos adicionales de seguridad y eficacia a largo plazo.
    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 Decision2013-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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