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    Summary
    EudraCT Number:2015-005786-23
    Sponsor's Protocol Code Number:XCEL-SCI-01
    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:2016-03-31
    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 number2015-005786-23
    A.3Full title of the trial
    A phase I/IIa, randomized, double-blind, single-dose, placebo controlled, two-way crossover clinical trial to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton?s jelly mesenchymal stem cells in chronic traumatic spinal cord injury
    Estudio clínico piloto de fase I/IIa, aleatorizado, doble ciego, cruzado, de dos brazos de tratamiento, dosis única y controlado con placebo para evaluar la seguridad y obtener indicios de eficacia en la administración intratecal de células mesenquimales expandidas de gelatina de Wharton en la lesión medular traumática crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety assessment of cord blood mesenchymal stromal cells in chronic spinal cord injury
    Evaluación de la seguridad de células mesenquimales estromales de cordón umbilical en lesión medular crónica
    A.3.2Name or abbreviated title of the trial where available
    Wharton?s jelly mesenchymal stem cells for chronic traumatic spinal cord injury
    Células mesenquimales de gelatina de Wharton en la lesión medular traumática crónica
    A.4.1Sponsor's protocol code numberXCEL-SCI-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 supportBanc de Sang i Teixits
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportInstituto Guttmann
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFundació la Marató de TV3
    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 pointDirec Med División Terap Avanzadas
    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+3493557 35 006707
    B.5.5Fax number+3493557 35 02
    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 namecélulas mesenq troncales adultas alogénicas de gelatina de Wharton del CU expandidas criopreservadas
    D.3.2Product code XCEL-UMC-BETA
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdult allogeneic expanded and criopreserved umbilical cord WJ-derived mesenchymal stromal cells
    D.3.9.2Current sponsor codeXCEL-UMC-BETA
    D.3.9.3Other descriptive nameMESENCHYMAL STEM CELLS FROM WHARTON JELLY
    D.3.9.4EV Substance CodeSUB27304
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8000000 to 12000000
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion in pre-filled syringe
    D.8.4Route of administration of the placeboIntrathecal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic traumatic spinal cord injury
    Lesión medular traumática crónica
    E.1.1.1Medical condition in easily understood language
    Chronic traumatic spinal cord injury
    Lesión de médula espinal traumática crónica
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10041558
    E.1.2Term Spinal cord injury thoracic
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 safety of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution.
    Evaluar la seguridad de la infusión de XCEL-UMC-BETA en el tratamiento de la lesión medular traumática crónica completa y de nivel torácico, de 12 meses a 5 años de evolución.
    E.2.2Secondary objectives of the trial
    - To assess efficacy of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution, by:
    a) ASIA assessment
    b) Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves)
    c) Electrical pain threshold perception
    d) Urodynamic testing
    e) Anorectal manometry test
    - Clinical assessment of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution, by:
    a) Numerical scale for neuropathic pain assessment
    b) Modified Ashworth scale for spasticity
    c) SCIM III scale for functionality
    d) Quality of life questionnaire (EUROQOL-5D)
    e) Qualiveen questionnaire
    - Assessment of changes by magnetic resonance imaging
    Indicios de eficacia de la infusión de XCEL-UMC-BETA en el tratamiento de la lesión medular traumática crónica, de 12 meses a 5 años de evolución, mediante:
    a) Puntuación ASIA
    b) Pruebas electrofisiológicas (potenciales motores y somatosensoriales evocados, y ondas H y F)
    c) Umbral de percepción del dolor por corriente eléctrica.
    d) Pruebas funcionales de control de la vejiga mediante estudio urodinámico.
    e) Estudio funcional del intestino mediante manometría anorectal.
    - Evaluación clínica tras infusión de XCEL-UMC-BETA en el tratamiento de la lesión medular traumática crónica, de 12 meses a 5 años de evolución, mediante:
    a) Escala Numérica para el dolor neuropático
    b) Escala de Ashworth modificada para espasticidad
    c) Valoración funcional mediante la escala SCIM III
    d) Cuestionario de calidad de vida EUROQOL-5D
    e) Cuestionario Qualiveen
    - Evaluación de los cambios visualizados por resonancia magnética
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Single spinal cord injury lesion caused by trauma
    2. Affected cord segments between T2 and T11, confirmed by magnetic resonance
    3. Complete paraplegia (ASIA A)
    4. Chronic disease state (between 12 months and 5 years after the injury)
    5. Patients from 18 to 65 years of age, both sexes
    6. Life expectancy > 2 years
    7. Confidence that the patient will attend the follow-up visits.
    8. Given informed consent in writing
    9. Patient is able to understand the study and its procedures
    1. Lesión de médula espinal única de etiología traumática
    2. Afectación de los segmentos entre T2 y T11, confirmado por resonancia magnética
    3. Paraplejia completa (ASIA A)
    4. Estado crónico de la lesión (entre 12 meses y 5 años post lesión medular)
    5. Pacientes de ambos sexos entre 18 y 65 años (ambos incluidos)
    6. Paciente con expectativa de vida > 2 años
    7. Confianza en que el paciente podrá acudir a las visitas de seguimiento del estudio.
    8. Consentimiento Informado por escrito del paciente
    9. El paciente es capaz de entender la naturaleza del estudio
    E.4Principal exclusion criteria
    1. Mechanic ventilation
    2. Lesion affecting multiple levels
    3. Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance
    4. Penetrating trauma affecting the spinal cord
    5. Positive serology to HIV, HBV, HCV and or syphilis
    6. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
    7. Use of metal implants difficulting the MRI
    8. Planned spinal surgery within subsequent 24 month after entering the trial
    9. Intrathecal medication or immunossupresive drugs the previous 60 days.
    10. Neurodegenerative diseases
    11. Significant abnormal laboratory tests that contraindicates patient's participation in the study.
    12. Neoplasia within the previous 5 years, or without complete remission
    13. Patient with communication difficulties
    14. Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days
    15. Contraindication for lumbar punction
    16. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
    17. The patient does not accept to be followed-up for a period that could exceed the clinical trial length

    (*) Allowed anticonceptive methods are: hormones, intrauterine dispositive, barrier methods, voluntarily sterilization or menopause >1year duration.
    1. Ventilación mecánica
    2. Lesión afectando a múltiples niveles
    3. Longitud de la lesión de más de 3 segmentos medulares medido por resonancia magnética
    4. Traumatismo penetrante con afectación de la médula espinal
    5. Serología positiva para HIV, VHB, VHC y/o lúes
    6. Mujeres embarazadas o mujeres sin cobertura anticonceptiva eficaz según criterio del investigador (*), y mujeres en periodo de lactancia
    7. Instrumentación espinal compleja que dificulte la evaluación de la lesión por resonancia magnética
    8. Intervención quirúrgica planeada en la zona de la lesión dentro de los siguientes 24 meses de la inclusión en el estudio
    9. Tratamiento con medicación intratecal o inmunosupresora (incluidos los corticoides sistémicos) dentro de los 60 días anteriores a la inclusión en el estudio.
    10. Enfermedades neurodegenerativas
    11. Análisis hematológicos y bioquímicos con alteraciones significativas que contraindiquen la participación en el estudio.
    12. Enfermedad neoplásica detectada en los últimos cinco años o sin remisión completa.
    13. Dificultades de comunicación con los evaluadores
    14. Participación simultánea en otro ensayo clínico o tratamiento con otro producto en fase de Investigación en los 60 días previos a la inclusión en el estudio.
    15. Contraindicación para la punción lumbar
    16. Otras patologías o circunstancias que puedan comprometer la participación del paciente en el estudio según criterio médico.
    17. Negación del paciente a ser seguido por un periodo que excede el ensayo clínico en sí.
    (*) Los métodos anticonceptivos eficaces que se contemplaran en el protocolo son los hormonales, el dispositivo intrauterino (DIU), los métodos de barrera, la esterilización voluntaria o que la paciente tenga la menopausia de >1año de duración.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety assessment through adverse events, physical exam, vital signs and laboratory data.
    - Evaluación de la seguridad mediante exploración física, constantes vitales, datos de laboratorio y acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 12
    mes 12
    E.5.2Secondary end point(s)
    - Efficacy will be assessed though changes in respect to basal parameters for each period:
    a) ASIA punctuation at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study)
    b) Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves) at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study)
    c) Electrical pain threshold perception at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study)
    d) Urodynamic testing at 6 months (6 and 12 months of the trial)
    e) Anorectal manometry test at 6 months (6 and 12 months of the trial)
    - Assessment of clinical changes at 1, 3 and 6 months of each period (1, 3, 6, 7, 9 and 12 months of the study), in respect to basal parameters, for:
    a) Numerical scale for neuropathic pain assessment
    b) Modified Ashworth scale for spasticity
    c) SCIM III scale for functionality
    d) Quality of life questionnaire (EUROQOL-5D)
    e) Qualiveen questionnaire (at month 6 of each period) (6 and 12 months of the trial)
    - Changes by magnetic resonance imaging on the size and lesion characteristics at month 6 in respect to basal parameters, for each period (6 and 12 months of the trial)
    - La eficacia se evaluará mediante los cambios respecto al basal de las siguientes pruebas, en cada periodo:
    a) Puntuación ASIA al 1, 3 y 6 meses
    b) Pruebas electrofisiológicas (potenciales motores y somatosensoriales evocados, y ondas H y F) a los 1,3 y 6 meses
    c) Umbral de percepción del dolor por la corriente eléctrica a los 1, 3 y 6 meses
    d) Pruebas funcionales de control de la vejiga mediante estudio urodinámico a los 6 meses
    e) Estudio funcional del intestino mediante manometría anorectal a los 6 meses
    - Los cambios clínicos se evaluaran a los 1, 3 y 6 meses, respecto al basal, para los siguientes parámetros y para cada periodo:
    a) Escala numérica para el dolor neuropático
    b) Escala de Ashworth modificada para espasticidad
    c) Escala de valoración funcional SCIM III
    d) Test de calidad de vida EUROQOL-5D
    e) Cuestionario Qualiveen (a los 6 meses de cada periodo)
    - Los cambios en la neuroimagen se evaluarán con resonancia magnética mediante cambios en el tamaño y características de la lesión a los 6 meses, respecto al basal, para cada periodo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 12
    mes 12
    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 patient last visit
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 10
    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 state10
    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)
    All patients wil be periodically followed-up, at their standard point of care, after their participation in the trial to confirm long-term safety and effciacy
    Todos los pacientes seguirán controles periódicos por su médico, tras su participación en el estudio para confirmar la 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 Decision2016-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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