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    Summary
    EudraCT Number:2018-000805-22
    Sponsor's Protocol Code Number:A20175CI03
    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:2019-04-30
    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 number2018-000805-22
    A.3Full title of the trial
    A multi-center, double-blind, randomized, placebo-controlled, delayed- start phase II/III study to assess the efficacy and safety of Neuro-Cells in (sub)acute spinal cord injury patients
    Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo, en fase de inicio retardado II/III para evaluar la eficacia y la seguridad de Neuro-Cells en pacientes con lesiones de la médula espinal (sub) agudas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of the effectiveness and safety of an autologous stem cell product (Neuro-Cells) in patients with a (sub) acute spinal cord injury.
    Ensayo clínico sobre la efectividad y seguridad de un producto autologous de células madre (células neuronales) en pacientes con una lesión de la médula espinal subaguda.
    A.3.2Name or abbreviated title of the trial where available
    Stem Cells in Spiral Cord injury (SCI2)
    A.4.1Sponsor's protocol code numberA20175CI03
    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 SponsorNeuroplast BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNeuroplast BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroplast BV
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressUrmonderbaan 22 (Gate 2)
    B.5.3.2Town/ cityGeleen
    B.5.3.3Post code6167 RD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)850761000
    B.5.6E-mailinfo@neuroplast.com
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/0000002559
    D.3 Description of the IMP
    D.3.1Product nameNeuro-Cells
    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 IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNepla-tem-cel
    D.3.9.3Other descriptive nameAUTOLOGOUS BONE MARROW CONTAINING HEMATOPOIETIC AND MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB194911
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7.5 to 9.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product/EMA/474951/2012 (original name was AMARCELL but this has changed into Neuro-Cells)
    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 injection
    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
    Traumatic Spinal cord injury
    Lesion medular Traumática
    E.1.1.1Medical condition in easily understood language
    Paralysis of the limbs and/or trunk caused by a trauma of the spinal cord
    Parálisis de las extremidades y / o del tronco causada por un traumatismo de la médula espinal
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety: Characterize and confirm safety of intrathecal intervention of Neuro-Cells
    Efficacy: Investigate the effect of early administration of Neuro-Cells on the neurological (motor) condition at day 180 (visit 7)
    Seguridad: Caracterizar y confirmar la seguridad de la intervención intrathecal de Neuro-Cells.

    Eficacia: Investigar el efecto de la administración temprana de Neuro-Cells en la condición neurológica (motora) en el día 180 (visita 7)
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    Investigate the effect of late administration of Neuro-Cells on the neurological (motor) condition
    Investigate the effect of Neuro-Cells on the autonomic and sensory neurological dysfunction, daily activity level, quality of life, pain perception, spasticity, use of pain-reducing and spasticity-reducing medication at day 180 (visit 7) for the early group and day 365 (visit 12) for both groups.
    Investigar el efecto de la administración tardía de Neuro-Cells en la condición neurológica (motora)

    Investigar el efecto de Neuro-Cells en la disfunción neurológica autonómica y sensorial, nivel de actividad diaria, calidad de vida, percepción del dolor, espasticidad, uso de medicamentos para reducir el dolor y reducir la espasticidad en el día 180 (visita 7) para el grupo temprano y el día 365 (visita 12) para ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age range: 18 - 65 years
    2. Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of
    enrolment
    3. Randomization can be done within 36-56 days (6-8 weeks) after the TSCI incident
    4. Level of injury between C6 to T12
    5. Voluntary signed informed consent by patients and Investigator before any trial-related
    procedures are performed
    1. Rango de edad: 18 - 65 años
    2. TSCI completo (grado AIS A) o incompleto (grado AIS B o C) (evaluado por ISNCSCI) en el
    momento de la inscripción
    3. La aleatorización se puede hacer dentro de los 36-56 días (6-8 semanas) después del incidente del TSCI
    4. Nivel de lesión entre C6 y T12
    5. Consentimiento voluntario firmado por pacientes e investigador antes de que se realicen
    procedimientos relacionados con el ensayo
    E.4Principal exclusion criteria
    1. SCI AIS grade D or E at the start of enrolment
    2. Allergic to mice antibodies and/or iron-dextran
    3. Level of SCI above C6 or below T12
    4. Positive HIV, hepatitis B or C serology
    5. Positive Lues test
    6. Total Nuclear Cell (TNC) count <1x109 TNC in bone marrow sample
    7. Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative
    disorder (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis etc.), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator’s discretion
    8. Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti- inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed)
    9. Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g., heroin, cocaine, XTC)
    10. Individuals that belong to vulnerable population groups
    11. Females with childbearing potential without using adequate birth control methods (e.g.,
    contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged release), subdermal implantation, vaginal ring, or transdermal patches), and/or being pregnant or in the lactation period
    12. Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial
    13. Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
    14. Patients who are unable to comply with the requirements of this clinical trial
    1. SCI AIS grado D o E al inicio de la inscripción
    2. Alérgico a anticuerpos de ratones y/o hierro-dextrano
    3. Nivel de SCI por encima de C6 o por debajo de T12
    4. Serología positiva del VIH, hepatitis B o C
    5. Prueba positiva de Lues
    6. Recuento total de células nucleares (CNC) <1x109 TNC en la muestra de médula ósea
    7. Cáncer, lesión cerebral, alteración de la conciencia, signos/síntomas del trastorno
    neurodegenerativo (por ejemplo, accidente cerebrovascular, esclerosis lateral amiotrófica, esclerosis múltiple, etc.), diabetes mellitus tipo 1, insuficiencia renal o cardíaca basada en antecedentes de anamnesis y a discreción del investigador
    8. Cualquier tratamiento o medicamento concomitante que interfiera con la conducción del ensayo, como medicamentos inmunorresupresores u otros medicamentos (especialmente metotrexato, ciclosporina y corticosteroides deben evitarse) conocido por interactuar con las acciones antiinflamatorias e inmunomoduladoras de las células madre (no esteroides antiinflamatorios (AINE) están permitidos)
    9. Abuso de alcohol (consumo diario de más de 2 unidades de alcohol que contienen bebidas) o drogas ilícitas (por ejemplo, heroína, cocaína, XTC)
    10. Individuos que pertenecen a grupos de población vulnerables
    11. Hembras con potencial fértil sin utilizar métodos anticonceptivos adecuados (por ejemplo,
    píldoras anticonceptivas, dispositivos intrauterinos (DIU), inyecciones anticonceptivas (liberación prolongada), implantación subdérmica, anillo vaginal o parches transdérmicos), y/o estar embarazadas o en el período de lactancia
    12. Participación en cualquier ensayo clínico (con exención de estudios descriptivos con cuestionarios y sin intervención activa) dentro de los 30 días anteriores antes de la inscripción, o participación simultánea en dicho ensayo
    13. Los pacientes con comorbilidad extrema antes o después de la TSCI quedan excluidos a discreción de la PI
    14. Pacientes que no pueden cumplir con los requisitos de este ensayo clínico
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety
    90 days after treatment (visit 6 for early group, visit 11 for late group):
    - Physical examination status (checklist)
    - Biochemical changes in blood and urine Adverse events incidences and severity reported during the study (first to last visit)
    Primary efficacy:
    Increase in the American Spinal Injury Association motor scores (ASIAms) with additional 5 points. Baseline measurements (day 0, visit 2) are compared to day 180 (visit 7) for both early and late administration groups.
    Seguridad primaria
    90 días después del tratamiento (visita 6 para grupos tempranos, visite 11 para grupos tardíos): - Estado del examen físico (lista de
    verificación)
    - Cambios bioquímicos en sangre y orina Incidencias adversas y gravedad notificadas durante el estudio (primero a última visita)
    Eficacia primaria:
    Aumento en las puntuaciones motoras de la Asociación Americana de Lesiones Espinales (ASIAms) con 5 puntos adicionales. Las mediciones de la línea B (día0, visita 2) se comparan con el día 180 (visita 7) para grupos de administración temprana y tardía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, 90 and 180 of the study
    Dia 0, 90 y 180 del estudio.
    E.5.2Secondary end point(s)
    Secondary efficacy:
    Increase in the American Spinal Injury Association motor scores (ASIAms) with additional 5 points. Baseline measurements (day 0, visit 2) are compared to day 180 (visit 7) for the early group and day 365 (visit 12) for the late administration group.
    In the early group the following secondary endpoints will be studied at baseline, day 180 and day 365 compared to the late administration group:
    - Increase in ASIA sensory scores ASIAss
    (pinprick and light touch),
    - Functional outcome using Spinal Cord
    Independence Measure (SCIM) III assessments
    - Pain perception and pain-reducing medication,
    - Spasticity measurements of the knee and hip
    flexor and extensor muscles using the Modified Ashworth Scale (MAS) and actual spasticity- reducing medication, General wellbeing: 3 question items QoL
    In the late group the following secondary endpoints will be studied at baseline and day 365 compared to the early administration group:
    - Increase in ASIA sensory scores ASIAss (pinprick
    and light touch),
    - Functional outcome using Spinal Cord
    Independence Measure (SCIM) III assessments
    - Pain perception and pain-reducing medication,
    - Spasticity measurements of the knee and hip
    flexor and extensor muscles using the Modified Ashworth Scale (MAS) and actual spasticity- reducing medication, General wellbeing: 3 question items QoL
    Eficacia secundaria:
    Aumento en las puntuaciones motoras de la Asociación Americana de Lesiones Espinales (ASIAms) con 5 puntos adicionales. Las mediciones basales (día 0, visita 2) se comparan con el día 180 (visita 7) para el grupo temprano y el día 365 (visita 12) para el grupo de administración tardía.
    En el grupo inicial se estudiarán las siguientes variables secundarias en la línea de base, el día 180 y el día 365 en comparación con el grupo de administración tardía:
    - Aumento de las puntuaciones sensoriales ASIA ASIAss (pinprick y light touch),
    - Resultado funcional mediante las evaluaciones de la Medición de Independencia de la Médula Espinal (SCIM) III
    - Percepción del dolor y medicamentos para reducir el dolor,
    - Mediciones de espasticidad del flexor de rodilla y cadera y los músculos extensores usando la cal Modified Ashworth Scale (MAS) y la medicación real para reducir la espasticidad, Bienestar general: 3 elementos de preguntas QoL
    En el grupo tardío, los siguientes puntos finales secundarios se estudiarán en la línea de base y el día 365 en comparación con el grupo de administración temprana:
    - Aumento de las puntuaciones sensoriales ASIA
    ASIAss (pinprick y light touch),
    - Resultado funcional mediante las evaluaciones
    de la Medición de Independencia de la Médula
    Espinal (SCIM) III
    - Percepción del dolor y medicamentos para
    reducir el dolor,
    - Mediciones de espasticidad del flexor de rodilla
    y cadera y los músculos extensores usando la cal Modified Ashworth Scale (MAS) y la medicación real para reducir la espasticidad, Bienestar general: 3 elementos de preguntas QoL
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, 180 and 365 of study.
    Dia 0,180 y 365 del estudio.
    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 No
    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 No
    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) Yes
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Delayed- start protocol
    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 trial4
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Yes
    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 Ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 70
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    None
    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 Decision2021-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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