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    Summary
    EudraCT Number:2021-000346-18
    Sponsor's Protocol Code Number:BST-SCI-02
    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:2022-07-11
    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 number2021-000346-18
    A.3Full title of the trial
    A phase I/II, randomized, double-blind, placebo-controlled, parallel, 2-arms clinical trial to assess the safety and efficacy of intrathecal administration of WJ-MSC in chronic traumatic cervical incomplete spinal cord injury
    Ensayo clínico fase I/II, aleatorizado, doble ciego, paralelo, de 2 brazos y controlado con placebo para evaluar la seguridad y la eficacia de la administración intratecal de WJ-MSC en el tratamiento de la lesión medular cervical incompleta traumática crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy assessment of cord blood mesenchymal stromal cells in chronic cervical spinal cord injury
    Evaluación de la seguridad de células mesenquimales estromales de cordón umbilical en lesión medular cervical crónica
    A.4.1Sponsor's protocol code numberBST-SCI-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 supportSpanish Ministry of Science, Innovation and Universities
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportBanc de Sang i Teixits
    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 pointSponsor
    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 number349355735006707
    B.5.5Fax number34935573502
    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-UMC-BETA
    D.3.4Pharmaceutical form Infusion
    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 INNex vivo cultured human mesenchymal stem cells from Wharton jelly
    D.3.9.2Current sponsor codeXCEL-UMC-BETA
    D.3.9.3Other descriptive nameEX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB190865
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number700000 to 1000000
    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 placeboInfusion
    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
    Cronic traumatic spinal cord injury
    Lesión medular traumática crónica
    E.1.1.1Medical condition in easily understood language
    Cronic traumatic spinal cord injury
    Lesión medular 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10041554
    E.1.2Term Spinal cord injury cervical
    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 intratecal infusion of XCEL-UMC-BETA
    Evaluar la seguridad de la infusión intratecal de XCEL-UMC-BETA
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of the intrathecal infusion of XCEL-UMC-BETA, by:
    - ASIA punctuation
    - Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves)
    - Electrical pain threshold perception
    - Handgrip Strength by dynamometer
    - Walk test WISCIII
    - Numerical scale for neuropathic pain assessment
    - Modified Ashworth scale for spasticity
    - SCIM III scale for functionality
    - Quality of life questionnaire (WHOQOL-BREF)
    - Psychological examination (IBP, HAD)
    - Social work survey (CIQ-IG)
    - AntiHLA antibodies in cerebrospinal fluid (CSF)
    - Detection of donor cells in CSF
    Evaluar la eficacia de la infusión intratecal de XCEL-UMC-BETA, mediante:
    - Puntuación ASIA
    - Pruebas electrofisiológicas (potenciales motores y somatosensoriales evocados, y ondas H en músculo soleos y F de músculo AH bilateral)
    - Umbral de percepción del estímulo eléctrico y de percepción del dolor inducido por corriente eléctrica.
    - Fuerza de prensión mediante dinamómetro
    - Test de caminar WISCIII
    - Escala Numérica para el dolor neuropático
    - Escala de Ashworth modificada para espasticidad
    - Valoración funcional mediante la escala SCIM III
    - Cuestionario de calidad de vida WHOQOL-BREF
    - Exploración psicológica (IBP, HAD)
    - Encuesta trabajo social (CIQ-IG)
    - Detección de Ac-AntiHLA en LCR
    - Detección de células del donante en LCR
    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 C1 and T1, confirmed by magnetic resonance
    3. Incomplete lesion (ASIA B, C or D)
    4. Chronic disease state (between 1 and 5 years after the injury)
    5. Patients from 18 to 70 years of age, both sexes
    6. Life expectancy > 2 years
    7. Residence near the center during study participation and 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 única de médula espinal de etiología traumática
    2. Afectación de los segmentos cervicales C1-T1, confirmado por resonancia magnética
    3. Lesión incompleta (ASIA B, C o D)
    4. Lesión medular de 1 a 5 años de evolución
    5. Pacientes de ambos sexos entre 18 y 70 años (ambos incluidos)
    6. Paciente con expectativa de vida > 2 años
    7. Residencia cercana al centro durante la participación en el estudio y confianza en que el paciente podrá acudir a las visitas de seguimiento del estudio.
    8. Consentimiento Informado por escrito
    9. El paciente es capaz de entender la naturaleza del estudio
    E.4Principal exclusion criteria
    1. Mechanic ventilation
    2. Penetrating trauma affecting the spinal cord
    3. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
    4. Planned spinal surgery within subsequent 12 month after entering the trial
    5. Neurodegenerative diseases
    6. Significant abnormal laboratory tests that contraindicates patient's participation in the study
    7. Neoplasia within the previous 5 years, or without complete remission
    8. Patient with communication difficulties
    9. Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
    10. Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
    11. Contraindication for lumbar punction
    12. Contraindication or inability to follow a rehabilitation program
    13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
    14. 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. Traumatismo penetrante con afectación de la médula espinal
    3. Mujeres embarazadas o mujeres sin cobertura anticonceptiva eficaz según criterio del investigador (*), y mujeres en periodo de lactancia
    4. Intervención quirúrgica planeada en la zona de la lesión dentro de los siguientes 12 meses de la inclusión en el estudio
    5. Enfermedades neurodegenerativas
    6. Análisis hematológicos y bioquímicos con alteraciones significativas que contraindiquen la participación en el estudio.
    7. Enfermedad neoplásica detectada en los últimos cinco años o sin remisión completa.
    8. Dificultades de comunicación con los evaluadores
    9. 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, que pueda interferir en los resultados del estudio.
    10. Tratamiento previo con medicación de terapia avanzada (terapia celular)
    11. Contraindicación para la punción lumbar
    12. Contraindicación o imposibilidad de seguir un programa de rehabilitación
    13. Otras patologías o circunstancias que puedan comprometer la participación del paciente en el estudio según criterio médico.
    14. 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 will be assessed by physical examination, vital signs, laboratory data, and adverse events
    La seguridad se evaluará mediante exploración física, constantes vitales, datos de laboratorio, y acontecimientos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months follow-up
    A los 12 meses de tratamiento
    E.5.2Secondary end point(s)
    - Changes from baseline in ASIA score at 1, 3, 4, 6 and 12 m, compared with placebo
    - Changes from baseline in electrophysiological tests at 6 and 12 m, compared with placebo
    -Changes with respect to the baseline in the threshold of perception of the electrical stimulus and of perception of pain by electrical current (in 7 levels: 1 level above, and -1, -2, -3, -4, -5 and -6 for below the lesion) at 3, 6, and 12 m, compared with placebo.
    - Changes from baseline in grasping, pressing and pinching strength by dynamometer at 6 and 12 m, compared with placebo.
    - Changes from baseline in the WISCIII Walk test at 6 and 12 m, compared with placebo.
    - Changes from baseline in the numerical scale for neuropathic pain at 6 and 12 m, compared with placebo.
    -Changes from baseline in the modified Ashworth Scale for spasticity at 6 and 12 m, compared with placebo.
    -Changes from baseline in the SCIM III scale at 6 and 12 m, compared with placebo.
    -Changes from baseline in the WHOQOL-BREF questionnaire at 6 and 12 m, compared with placebo.
    -Changes from baseline in the psychological examination at 12 m, compared with placebo.
    -Changes from baseline in the social work survey at 12 m, compared with placebo.
    - Presence or absence of ab-antiHLA in CSF after infusion of WJ-MSC (1 and 4 months).
    - The detection of donor cells in CSF will be assessed by detecting the presence or absence of donor cells (product infused) in the recipient CSF at 7 days after each infusion of WJ-MSC.
    - Cambios respecto al basal en la puntuación ASIA a 1,3, 4, 6 y 12 m, comparado con placebo
    - Cambios respecto al basal en las pruebas electrofisiológicas a los 6 y 12 m, comparado con placebo.
    - Cambios respecto al basal en el umbral de percepción del estímulo eléctrico y de percepción del dolor por corriente eléctrica (en 7 niveles: 1 nivel por encima, y -1,-2,-3,-4,-5 y -6 por debajo de la lesión) a los 3, 6, y 12 m, comparado con placebo.
    - Cambios respecto al basal en la fuerza de agarre, prensión y pinza (grasping, pressing and pinching) mediante dinamómetro a los 6 y 12 m, comparado con placebo.
    - Cambios respecto al basal en el Walk test WISCIII a los 6 y 12 m, comparado con placebo.
    - Cambios respecto al basal en la Escala Numérica para el dolor neuropático a 6 y 12 m, comparado con placebo.
    - Cambios respecto al basal en la escala de Ashworth modificada para espasticidad a los 6 y 12 m, comparado con placebo
    - Cambios respecto al basal en la escala SCIM III a los 6 y 12 m, comparado con placebo
    - Cambios respecto al basal en el cuestionario WHOQOL-BREF a los 6 y 12 m, comparado con placebo
    - Cambios respecto al basal en la exploración psicológica a los 12 m, comparado con placebo.
    - Cambios respecto al basal en la encuesta de trabajo social a los 12 m, comparado con placebo.
    - Presencia o ausencia de ac-antiHLA en LCR tras la infusión de WJ-MSC (1 y 4 meses).
    - La detección de células del donante en LCR se evaluará mediante la detección de presencia o ausencia de células del donante (producto infundido) en el LCR del receptor a los 7 días de cada infusión de WJ-MSC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 7 days and at 1, 3, 4, 6 and 12 months follow-up.
    A los 7 días y a 1,3, 4, 6 y 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
    Safety study
    Estudio de seguridad
    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 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 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 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 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state18
    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 followed up to 24 month after their participation in the trial to confirm long-term safety and effciacy
    Todos los pacientes seguirán controles periódicos por su médico hasta 24 meses 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 Decision2021-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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