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    Summary
    EudraCT Number:2016-003029-40
    Sponsor's Protocol Code Number:IOBA-01-2016
    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:2016-12-09
    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 number2016-003029-40
    A.3Full title of the trial
    Phase II safety assessment of intravitreal injection of mesenchymal stem cells for acute non arteritic anterior ischemic optic neuropathy (NAION)
    Estudio de Fase II de la seguridad de las células madre mesenquimales MSV® en inyección intravítrea para el tratamiento de pacientes con neuropatía óptica isquémica anterior no arterítica aguda
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety study of stem cell injection for non arteritic anterior ischemic optic neuropathy
    Estudio de seguridad de la inyección intravítrea de células madre para el tratamiento de la neuropatía óptica isquémica anterior no arterítica aguda
    A.4.1Sponsor's protocol code numberIOBA-01-2016
    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 SponsorIOBA - University of Valladolid
    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 supportIOBA - University of Valladolid
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIOBA - University of Valldolid
    B.5.2Functional name of contact pointFrancisco Blazquez
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Belen 17
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47011
    B.5.3.4CountrySpain
    B.5.4Telephone number983184734
    B.5.5Fax number983186375
    B.5.6E-mailblazquez@ioba.med.uva.es
    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 name15-007 MSV
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllogeneic bone marrow stem adult mesenchymal cells
    D.3.9.3Other descriptive name15-007 MSV
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non arteritic anterior ischemic optic neuropathy (NAION)
    Neuropatía óptica isquémica anterior no arterítica aguda
    E.1.1.1Medical condition in easily understood language
    Non arteritic anterior ischemic optic neuropathy (NAION)
    Neuropatía óptica isquémica anterior no arterítica aguda
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the safety of Intravitreal mesenchymal stem cells in patients with Non arteritic anterior ischemic optic neuropathy (NAION) in the acute fase
    Evaluar la seguridad de la administración intravítrea de MSV® en pacientes con neuropatía óptica isquémica anterior no arterítica aguda en los momentos iniciales del proceso.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:

    a) Sudden and unpainful monocular vision loss
    b) Visual field defects
    c) Dyschromatopsia.
    d) Ocular nerve head edema.
    e) Afferent relative pupil defect.

    - Patients ≥ 50 years old, able to freely give informed consent.
    - Best corrected visual acuity (BCVA) ≤ 0,1 in study eye.
    - Pseudophakia in study eye.
    - Preserved pupilas sphyncter muscle motility
    - Signed informed consent form before any study procedure.
    - Signed data protection consent form before any study procedure.
    - Pacientes con NOIANA aguda unilateral (entre las primeras 2 semanas tras el inicio de los síntomas). Los pacientes diagnosticados de NOIANA definida por al menos dos de las siguientes características clínicas:
    a) Pérdida brusca e indolora de la visión monocular.
    b) Defectos del campo visual.
    c) Discromatopsia.
    d) Edema de la cabeza del nervio óptico.
    e) Defecto pupilar aferente relativo (DPAR).
    - Pacientes ≥ 50 años de edad, capaz de otorgar libremente el consentimiento informado para la participación en el estudio.
    - Agudeza visual entre ≤ 0,1 en el ojo afectado.
    - Pacientes pseudofáquicos en el ojo afectado.
    - Motilidad del músculo esfínter pupilar conservada.
    - Pacientes que entiendan y firmen el consentimiento informado previo a cualquier prueba del estudio.
    - Firma del formulario de protección de datos previo a cualquier prueba del estudio.
    E.4Principal exclusion criteria
    General exclusion criteria

    - Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
    - Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
    - History of systemic vasculitis, multiple sclerosis, colagenopathies or previous cancer treatments.
    - Hipersensitivity or allergy to any compound used in the study, including IMP.
    - Positive pregnancy test at baseline
    - Participation in any other research study within 2 months

    Ophthalmic exclusion criteria

    - History of uveitis or active ocular inflammation
    - History or evidente of glaucoma or high intraocular pressure ( ≥ 24 mmHg in either eye).
    - Mean opacities or retinal pathologies in the study eye.
    - Any previous vitreous or glaucoma surgery in the study eye
    -Cataract surgery within 3 months in the study eye
    Criterios de exclusión generales

    - Evidencia de arteritis de células gigantes (historia clínica, VSG, PCR [valores de referencia Anexo II])
    - Evidencia de cualquier otra etiología que justifique la neuropatía óptica (incluso en el ojo contralateral)
    - Antecedentes de vasculitis sistémica, esclerosis multiple, colagenopatías o tratamientos para cáncer.
    - Hipersensibilidad o alergia a cualquiera de los principios activos o los excipientes de la medicación.
    - Test de embarazo positivo.
    - Participación en cualquier otro estudio clínico con fármacos o instrumentos diagnósticos o terapéuticos en los dos meses anteriores a la participación en el estudio.

    Criterios de exclusión oftalmológicos

    - Antecedentes de uveítis o inflamación ocular activa.
    - Antecedentes o evidencias de glaucoma o PIO ≥ 24 mmHg en cualquiera de los dos ojos.
    - Opacidad de medios, patologías retinianas en el ojo afectado.
    - Pacientes sometidos a cualquier cirugía de vítreo o glaucoma en el ojo afectado
    - Cirugía de catarata previa en los 3 meses anteriores en el ojo afectado.
    E.5 End points
    E.5.1Primary end point(s)
    Main safety variable is defined by all of the following assessments. Any finding from the list means failure :

    - >1+ cells in anterior chamber
    - >1+ flare in anterior chamber
    - > 2+ vitreous flare

    All these items are graded following the SUN (standardization of uveitis nomenclature) scale
    • Gradación de células en cámara anterior >1+ y/o
    • Gradación del flare en cámara anterior > 1+ y/o
    • Gradación del flare en vítreo > 2+

    Según criterios de la escala SUN (estandarización de la nomenclatura en uveitis), evaluados en cada una de las visitas
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every scheduled visit after treatment, and at any unscheduled visit that any patient might need
    Todas las visitas programadas tras el tratamiento, así como en cualquiera de las no programadas que cualquier paciente pudiera necesitar
    E.5.2Secondary end point(s)
    - Adverse events procedure-related (intravitreal injection): conjunctival haemorrhages, anterior chamber inflammation, changes in intraocular pressure, infectious endotphthalmitis, vitreous inflammmation (cells or opacities), retinal detachment, choroidal detachment, corneal opacities, lens opacities, neovascularization, macular edema or any other adverse event that may appear.

    - Adverse events

    - Changes in best corrected visual acuity (BCVA) or ocular electrophysiology tests
    - Se evaluarán efectos adversos relacionados con la técnica de inyección intravítrea tales como: la aparición de hemorragias subconjuntivales, la inflamación de la cámara anterior, los cambios en la presión intraocular, la posible aparición de una endoftalmitis infecciosa, la inflamación en cavidad vítrea (células u opacidades), el desprendimiento de retina, el desprendimiento de coroides, las opacidades corneales, la opacidad del cristalino, la neovascularización, el edema macular o cualquier otro hallazgo adverso que pudiera detectarse.

    - Acontecimientos adversos

    - Se evaluarán cambios en la agudeza visual (AV) y en las pruebas de electrofisiología ocular.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At every scheduled visit after treatment, and at any unscheduled visit that any patient might need
    Todas las visitas programadas tras el tratamiento, así como en cualquiera de las no programadas que cualquier paciente pudiera necesitar
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    Unexpected rate of serious adverse reactions related to IMP in more than a half of the patients
    Aparición de un número no esperado de reacciones adversas graves al producto en investigación en más de la mitad de los pacientes
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 5
    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 state5
    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
    Ninguno
    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 Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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