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    Summary
    EudraCT Number:2011-000598-30
    Sponsor's Protocol Code Number:CS001-EU01
    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:2011-10-18
    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 number2011-000598-30
    A.3Full title of the trial
    MULTICENTER STUDY OF CULTURED AUTOLOGOUS ORAL MUCOSAL EPITHELIAL CELL-SHEET (CAOMECS) TRANSPLANTATION TO PATIENTS WITH TOTAL LIMBAL STEM CELL DEFICIENCY
    ESTUDIO MULTICÉNTRICO DE TRASPLANTE DE CÉLULAS EPITELIALES AUTÓLOGAS DE LA MUCOSA ORAL CULTIVADAS EN LÁMINAS (CAOMECS) EN PACIENTES CON DÉFICIT TOTAL DE CÉLULAS MADRE LIMBARES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the activity of CAOMECS graft to restore the occular surface tissue of patients with total limbal stem cell deficiency
    Para evaluar la actividad del injerto (CAOMECS) para restaurar el tejido de la superficie ocular en los pacientes con deficit total de células madre limbares
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberCS001-EU01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/118/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCellseed France S.A.R.L.
    B.1.3.4CountryFrance
    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 supportCellseed France S.A.R.L.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCellSeed France S.A.R.L.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address5 Place Charles Béraudier
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69428
    B.5.3.4CountryFrance
    B.5.4Telephone number+436648128600
    B.5.5Fax number+81352866233
    B.5.6E-mailhhasibeder@cellseed.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCAOMECS
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAOMECS (Cultured Autologous Oral Mucosal Epithelial Cell-Sheet)
    D.3.9.2Current sponsor codeCAOMECS
    D.3.9.3Other descriptive nameCAOMECS
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 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
    Limbal Stem Cell Deficiency of the Eye
    DÉFICIT TOTAL DE CÉLULAS MADRE LIMBARES EN EL OJO.
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with total limbal stem cells
    deficiency with moderate and severe symptoms, caused
    by severe exogenous trauma or endogenous eye disease
    Tratamiento de pacientes con deficiencia total de células madre limbares con síntomas moderados y severos, causados por traumas graves exógenos o enfermedad de los ojos endógena.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10063581
    E.1.2Term Stem cell transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To restore the ocular surface epithelium by preventing recurrent conjunctivalization and neovacularization up to 12 months post transplantation.
    Restituir el epitelio de la superficie ocular evitando o reduciendo la conjuntivalización y la neovascularización hasta 12 meses después del trasplante.
    E.2.2Secondary objectives of the trial
    Presence of a stable coreal epithilium and absence of conjunctivalisation at each follow-up visit at month 24 and 36.
    Prevention of recurrent neovacularization at each follow-up visit at month 24 and 36.
    To reduce the amount of punctate epithelial keratophathy.
    To increase the transparency of the epithelium at each follow-up visit.
    To improve visual acuity from Baseline to each follow-up visit.
    To improve photophobia, watering, and pain symptoms from Baseline to each follow-up visit.
    Change in patients' quality of life from Baseline to each follow-up visit (assessed by VFQ25 questionnaire).
    1.Presencia de un epitelio corneal estable y ausencia de conjuntivalización en el eje visual en cada visita de seguimiento en los meses 24 y 36.
    2.Grado de neovascularización en cada visita de seguimiento en los meses 24 y 36.
    3.Queratopatía epitelial punteada en cada visita de seguimiento
    4.Presencia de un epitelio transparente en el eje visual en cada visita de seguimiento
    5.Mejoría de la agudeza visual en cada visita de seguimiento en comparación con la situación basal
    6.Mejoría de la fotofobia en cada visita de seguimiento en comparación con la situación basal
    7.Cambios en la calidad de vida evaluados mediante el Cuestionario de Función Visual 25 (VFQ25) del National Eye Institute en cada visita de seguimiento en comparación con la situación basal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for all patients:
    1. Age > or = to 2 years to 74 years
    2. Males or females with bilateral or unilateral total LSCD due to one of the following causes:
    a) Chemical burns
    b) Thermal burns
    c) Contact lens wear
    d) Surgery of the ocular surface
    e) Stevens-Johnson syndrome and other inflammatory disease under stable condition
    f) Aniridia
    3. Documented conjunctivalization of the corneal surface, measured by fluorescein staining
    4. Stable disease, i.e. history of LSCD for at least 6 months
    5. Clinical signs indicative of conjunctivalisation:
    a) Superficial blood vessels on the corneal surface
    b) Loss of epithelial transparency or persistent epithelial defect
    6. Healthy oral mucosa
    7. Absence from tobacco and alcohol (7 days before the biopsy)
    8. Regular tooth brushing (at least twice daily)
    9. Ability to comply with the protocol
    10. Covered by a social security system
    11. Signed informed consent form, ability to understand the study procedures, and contractual capability. Applicable to patient or legal carer (including parent)

    Special inclusion criteria for patients between 18 and 74 years of age (adults):
    12. Multiple surgeries in the limbal region
    Criterios de inclusión para todos los pacientes:
    1.Edad > o = a 2 años a 74 años
    2.Varones o mujeres con DCML total, bilateral o unilateral, debido a una de las siguientes causas:
    a)Quemaduras químicas
    b)Quemaduras térmicas
    c)Desgaste por lentes de contacto
    d)Cirugía de la superficie ocular
    e)Síndrome de Stevens-Johnson y otras enfermedades inflamatorias en situación estable
    f)Aniridia
    3.Conjuntivalización documentada de la superficie corneal, determinada mediante tinción con fluoresceína
    4.Enfermedad estable, es decir, DCML total durante al menos 6 meses
    5.Signos clínicos indicativos de conjuntivalización:
    a)Vasos sanguíneos superficiales en la superficie corneal
    b)Pérdida de la transparencia epitelial o defecto epitelial persistente
    6.Mucosa oral sana
    7.Abstinencia de tabaco y alcohol (7 días antes de la biopsia)
    8.Cepillado dental habitual (al menos dos veces al día)
    9.Capacidad para cumplir el protocolo
    10.Cubierto por un sistema de seguridad social
    11.Documento de consentimiento informado firmado, capacidad para entender los procedimientos del estudio y capacidad contractual. Aplicable al paciente o al cuidador legal (incluido padre/madre)
    Criterios de inclusión especiales para los pacientes con edades comprendidas entre los 18 y 74 años (adultos):
    12.Múltiples cirugías en la región limbar.
    E.4Principal exclusion criteria
    Exclusion criteria for all patients:
    1. Acute systemic infection
    2. Acute ocular inflammation in the previous 6 months
    3. Previous neoplastic/cancer disease
    4. Severe dry eye confirmed by a Schirmer test
    5. Lyell-Syndrome, epidermolysis bullosa
    6. Total symblepharon
    7. Medical history of hypersensitivity or allergy to bovine or murine derived materials
    8. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
    9. Any systemic infectious disease as diagnosed by serology tests such as syphilis, HIV-1, HIV-2, hepatitis B or C, or HTLV-1 infection at screening and at the day of the biopsy
    10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study
    11. Previous participation of the patient in this study
    12. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications
    13. Employees of the sponsor or patients who are employees or relatives of the investigator
    14. Genetic conditions such as ectodermal dysplasia or multiple endocrine neoplasia

    Special exclusion criteria for patients ?2 and <18 years of age (children):
    15. Multiple surgeries in the limbal region
    Criterios de exclusión para todos los pacientes:
    1.Infección sistémica aguda
    2.Inflamación ocular aguda en los 6 meses anteriores
    3.Enfermedad neoplásica/cáncer previa
    4.Sequedad ocular intensa confirmada mediante el test de Schirmer
    5.Síndrome de Lyell, epidermólisis bullosa
    6.Simbléfaron total
    7.Antecedentes médicos de hipersensibilidad o alergia a materiales de derivados bovinos o murinos
    8.Pacientes embarazadas o en periodo de lactancia, prueba de embarazo en orina positiva en mujeres con capacidad de concebir
    9.Cualquier infección sistémica diagnosticada mediante pruebas serológicas, como sífilis e infección por VIH-1, VIH-2, hepatitis B o C, o VLTH-1 en la selección y el día de la biopsia.
    10.Tratamiento en curso o anterior (en los 30 días previos a la inclusión) con otro fármaco en investigación o participación en otro estudio clínico
    11.Participación previa del paciente en este estudio
    12.Indicios de otros trastornos médicos (como enfermedad psiquiátrica, exploración física o resultados analíticos) que pudieran interferir con el tratamiento programado, afectar al cumplimiento por parte del paciente o exponer al paciente a un gran riesgo de complicaciones relacionadas con el tratamiento
    13.Empleados del promotor o pacientes que sean empleados o parientes del investigador
    14.Enfermedades genéticas como la displasia ectodérmica o la neoplasia endocrina múltiple
    Criterios de exclusión especiales para los pacientes de > o = a 2 y < a 18 años de edad (niños):
    15.Múltiples cirugías en la región limbar.
    E.5 End points
    E.5.1Primary end point(s)
    1. Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis at month 12 (success is defined as the absence of goblet cells, indicative of corneal phenotype) assessed by delayed fluorescein staining and impression cytology
    2. Extent of neovascularization at month 12 (success is defined as a reduction of ?50% compared to Baseline

    Criteria for evaluation - children
    As for primary endpoint No.1, assessments are only performed if investigator considered them feasible. Other than this item, the primary endpoint No.2 for adult patients will be applied for children.
    1.Presencia de un epitelio estable en la córnea y ausencia de conjuntivalización en el eje visual en el mes 12 (la eficacia se define como la ausencia de células caliciformes, indicativas de fenotipo corneal), evaluada mediante el retraso en la captación de fluoresceína y la citología de impresión
    2.Grado de neovascularización en el mes 12 (la eficacia se define como una reducción > ó = al 50% con respecto a la situación basal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.5.2Secondary end point(s)
    1. Presence of a stable corneal epithelium and absence of conjunctivalization in the visual axis at each follow-up visit at month 24 and 36 assessed by delayed fluorescein staining and impression cytology
    2. Extent of neovascularization at each follow-up visit at month 24 and 36 (success is defined as a reduction of ?50% as compared to Baseline)
    3. Punctate epithelial keratopathy at each follow-up visit
    4. Improvement of visual acuity from Baseline to each follow-up visit
    5. Change in quality of life assessed by the National Eye Institute Visual Functioning Questionnaire 25 (VFQ25) from Baseline to each follow-up visit (a modified VFQ25 will be used for children and for unilateral cases)
    6. Presence of a transparent epithelium in the visual axis at each follow-up visit
    7. Improvement of photophobia from Baseline to each follow-up visit
    8. Improvement of watering from Baseline to each follow-up visit
    9. Improvement of pain from Baseline to each follow-up visit
    10. Suitability and risk status for a corneal graft (lamellar or full thickness) at month 12

    Criteria for evaluation - children
    As for secondary endpoint No. 1 and 4, assessments are only performed if investigator considered them feasible. Other than these items, the secondary endpoint No. 2, 3, 5 for adult patients will be applied for children.
    1.Presencia de un epitelio corneal estable y ausencia de conjuntivalización en el eje visual en cada visita de seguimiento en los meses 24 y 36, evaluada mediante retraso en la captación de fluoresceína y citología de impresión
    2.Grado de neovascularización en cada visita de seguimiento en los meses 24 y 36 (la eficacia se define como una reducción de ?50% con respecto a la situación basal)
    3.Queratopatía epitelial punteada en cada visita de seguimiento
    4.Mejoría de la agudeza visual en cada visita de seguimiento en comparación con la situación basal
    5.Cambios en la calidad de vida evaluados mediante el Cuestionario de Función Visual 25 (VFQ25) del National Eye Institute en cada visita de seguimiento en comparación con la situación basal (en los niños y en los casos unilaterales se usará un VFQ25 modificado)
    6.Presencia de un epitelio transparente en el eje visual en cada visita de seguimiento
    7.Mejoría de la fotofobia en cada visita de seguimiento en comparación con la situación basal
    8.Mejoría del lagrimeo en cada visita de seguimiento en comparación con la situación basal
    9.Mejoría del dolor en cada visita de seguimiento en comparación con la situación basal
    10.Situación de idoneidad y riesgo de injerto corneal (laminar o de grosor total) en el mes 12

    Criterios para la evaluación (niños)

    En cuanto al criterio de valoración principal nº 1 y los criterios de valoración secundarios nos 1 y 4, las evaluaciones solo se realizarán si el investigador las considera factibles. Aparte de estos elementos, el criterio de valoración principal nº 2 y los criterios de valoración secundarios nos 2, 3 y 5 de los pacientes adultos se aplicarán también a los niños.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12, 24, 36
    Mes 12, 24 y 36.
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    The end of the study is defined as the day of the last patient?s data obtained.
    Último dato del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Persons incapable of reading/writing due to desease stage, i.e. blindness.
    Personas incapaces de leer/escribir debido a la fase de su enfermedad, por ejemplo ceguera
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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)
    Patients who terminate the study prematurely for whatever reason will be treated adequately by the investigator at his discretion and according to the standard treatment guidelines.
    Los pacientes que discontinuen del ensayo por cualquier razón, serán tratados de acuerdo a lo que indique el Investigador, dentro de su práctica clínica habitual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/a
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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