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    Summary
    EudraCT Number:2016-001841-23
    Sponsor's Protocol Code Number:I.2016.010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-19
    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 number2016-001841-23
    A.3Full title of the trial
    A multicenter, randomized, open-label, two-arms phase I/II clinical trial to asses efficacy and safety of cord blood eye drops in neurotrophic keratopathy
    Estudio clínico de fase I/II, multicéntrico, aleatorizado, abierto, de dos brazos de tratamiento, para evaluar la eficacia y la seguridad del colirio de sangre de cordón umbilical en el tratamiento de la queratitis neurotrófica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of umbilical cord eye drops in neurotrophic keratopathy
    Uso de colirio de cordón umbilical en el tratamiento de la queratitis neurotrófica.
    A.3.2Name or abbreviated title of the trial where available
    Use of umbilical cord eye drops in neurotrophic keratopathy
    Uso de colirio de cordón umbilical en el tratamiento de la queratitis neurotrófica.
    A.4.1Sponsor's protocol code numberI.2016.010
    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.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 pointCord Blood Bannk Director
    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+349355735003635
    B.5.5Fax number+34935573502
    B.5.6E-mailsquerol@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 namecolirio de sangre de cordón umbilical
    D.3.2Product code colirio de sangre de cordón umbilical
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPLATELET CONCENTRATE
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000
    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) No
    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 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 Yes
    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
    Neurotrophic Keratitis, stage 2 or 3
    Queratitis neurotrófica en estadío 2 o 3
    E.1.1.1Medical condition in easily understood language
    Neurotrophic Keratitis, stage 2 or 3
    Queratitis neurotrófica en estadío 2 o 3
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10064996
    E.1.2Term Ulcerative keratitis
    E.1.2System Organ Class 10015919 - Eye 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 cord blood eye drops in Neurotrophic Keratitis treatment by changes in lesion size observed by slit lamp after 3 weeks of treatment.
    Evaluar la eficacia del colirio de sangre de cordón umbilical en el tratamiento de la Queratitis Neurotrófica mediante cambios en el tamaño de la lesión objetivados por lámpara de hendidura tras 3 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    -To assess the safety of cord blood eye drops in Neurotrophic Keratitis treatment.
    -To assess the efficacy of cord blood eye drops in Neurotrophic Keratitis treatment by changes in lesion size observed by slit lamp after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.
    -To assess the corneal sensibility after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.
    -To assess the corneal opacity by slit lamp after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.
    -To assess the visual acuity after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.
    -To assess the Neurotrophic Keratitis complications per treatment group.
    -Evaluar la seguridad del colirio de sangre de cordón umbilical en el tratamiento de la Queratitis Neurotrófica .
    -Evaluar la eficacia del colirio de sangre de cordón umbilical en el tratamiento de la Queratitis Neurotrófica mediante cambios en el tamaño de la lesión objetivados por lámpara de hendidura, a los 2-3 días y a las 1, 2 y 6 semanas.
    -Evaluar la sensibilidad corneal a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Evaluar la opacidad corneal mediante la lámpara de hendidura a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Agudeza visual 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Complicaciones de la Queratitis Neurotrófica por grupo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years old
    2. NK stage 2 or 3 (Mackie classification)
    3. Signed Informed Consent Form
    4. The patient is able to understand the nature of the study and to participate throughout its duration
    1. Edad ≥ 18 años
    2. Queratitis neurotrófica estadío 2 o 3 (clasificación de Mackie)
    3. Firma del consentimiento informado
    4. Paciente capaz de entender las condiciones del estudio y de participar durante toda su duración
    E.4Principal exclusion criteria
    1. Medical history of eye tumors
    2. Active eye infection
    3. Eyelid bad position or eyelid closure problems
    4. Conjunctiva scarring
    5. Topic chronic eye treatments with corticoids
    6. Acute corneal burns (<3 months)
    7. Intolerance to contact lens
    8. Allergy or inability to receive concomitant treatment with Exocin®
    9. Patients with immunosuppressive or chemotherapy treatment
    10. Pregnant woman or woman without proper contraceptive methods according to the investigator, or lactating women
    11. Participation in another clinical trial in the last month
    1. Antecedentes de tumores oculares
    2. Infección ocular activa
    3. Malposición palpebral o problemas de cierre palpebral
    4. Cicatrización conjuntival
    5. Tratamientos oculares tópicos crónicos con corticoides
    6. Quemaduras corneales agudas (<3 meses)
    7. Intolerancia para el uso de la lente de contacto
    8. Alergia o imposibilidad de recibir tratamiento concomitante con Exocin®
    9. Pacientes que reciban tratamiento con inmunosupresores o quimioterapia
    10. Mujeres embarazadas o mujeres sin cobertura anticonceptiva eficaz según criterio del investigador y mujeres en periodo de lactancia
    11. Participación en otro ensayo clínico en el último mes
    E.5 End points
    E.5.1Primary end point(s)
    -Variation percentage in corneal lesion size after 3 weeks post-treatment, per treatment group
    -Porcentaje de variación del tamaño de lesión corneal tras 3 semanas de tratamiento, por grupo de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 weeks post-treatment
    tras 3 semanas de tratamiento
    E.5.2Secondary end point(s)
    -Safety evaluation through laboratory data and adverse events, per treatment group.
    -Variation percentage in corneal lesion size at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment, per treatment group.
    -Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline, at 3 weeks post-treatment.
    -Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia) at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment.
    -Changes on corneal opacity from baseline (not response, improvement, worse) at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment.
    -Line variation in relation to visual acuity at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment.
    -Number of NK complications per treatment group.
    -Evaluación de la seguridad mediante datos de laboratorio y acontecimientos adversos, por grupo de tratamiento.
    -Porcentaje de variación del tamaño de la lesión corneal a los 2-3 días y a las 1, 2 y 6 semanas, por grupo de tratamiento.
    -Cambios de estadio de la lesión corneal, (curado, estadio 1, estadio 2, estadio 3), respecto al basal, a las 3 semanas de tratamiento.
    -Cambios en la escala cualitativa de sensibilidad corneal (normoestesia, hipoestesia, anestesia) a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Cambios respecto al basal en la opacidad corneal (igual, mejor, peor) a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Variación de líneas en relación a la agudeza visual a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    -Número de complicaciones de la QN por grupo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment.
    a los 2-3 días y a las 1, 2, 3 y 6 semanas.
    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 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) Yes
    E.8.2.2Placebo No
    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
    LPLV
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state42
    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)
    Standard medical care if needed
    Cuidados médicos habituales si son necesarios
    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 Decision2016-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-03-12
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