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    Summary
    EudraCT Number:2018-000523-14
    Sponsor's Protocol Code Number:EI17-00523
    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:2018-04-09
    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 number2018-000523-14
    A.3Full title of the trial
    Transplantation of autologous mesenchymal stem cells of adipose origin for the treatment of corneal diseases
    Trasplante de Células Madre Mesenquimales Autólogas de origen adiposo para el tratamiento de enfermedades corneales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transplantation of Autologous Stem Cells for the treatment of corneal diseases
    Trasplante de Células Madre Autólogas para el tratamiento de enfermedades corneales
    A.4.1Sponsor's protocol code numberEI17-00523
    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 SponsorUniversidad Miguel Hernandez
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCABYC S.L.
    B.5.2Functional name of contact pointCarolina Martín Bravo
    B.5.3 Address:
    B.5.3.1Street AddressAv. Somosierra, 12,. Portal izquierdo. 2ºG
    B.5.3.2Town/ citySan Sebastián de los Reyes (Madrid)
    B.5.3.3Post code28703
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916590433
    B.5.5Fax number0034916548969
    B.5.6E-mailcarolina.martin@cabyc.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 nameCÉLULAS MESENQUIMALES TRONCALES AUTÓLOGAS DE TEJIDO ADIPOSO EXPANDIDAS QUIESCENTES
    D.3.2Product code ADASCq
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCÉLULAS MESENQUIMALES TRONCALES AUTÓLOGAS DE TEJIDO ADIPOSO EXPANDIDAS QUIESCENTES/
    D.3.9.3Other descriptive nameCÉLULAS MESENQUIMALES TRONCALES AUTÓLOGAS DE TEJIDO ADIPOSO EXPANDIDAS QUIESCENTES/(ADASCq)
    D.3.9.4EV Substance CodeSUB30158
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    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) 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.IMP: 2
    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 nameLÁMINA ALOGÉNICA DE CÓRNEA DESCELULARIZADA(LChD)
    D.3.2Product code LChD
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLÁMINA ALOGÉNICA DE CÓRNEA DESCELULARIZADA(LChD
    D.3.9.3Other descriptive nameLÁMINA ALOGÉNICA DE CÓRNEA DESCELULARIZADA(LChD)
    D.3.9.4EV Substance CodeSUB30158
    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) 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 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 placeboImplant
    D.8.4Route of administration of the placeboIntraocular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Corneal Diseases
    Enfermedades Corneales
    E.1.1.1Medical condition in easily understood language
    Corneal Diseases
    Enfermedades Corneales
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023353
    E.1.2Term Keratoconus
    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 confirm the clinical safety and feasibility of regenerative corneal stromal treatment with autologous mesenchymal stem cells derived from subcutaneous adipose tissue (ADASCs) administered in corneal stroma in patients with corneal dystrophy with structural corneal weakening and consecutive loss of vision, within the framework of a phase I-IIa clinical trial.
    Confirmar inequívocamente la seguridad y factibilidad clínicas del tratamiento regenerativo del estroma corneal con células troncales mesenquimales autólogas derivadas de tejido adiposo subcutáneo (ADASCs) administradas en estroma corneal en pacientes portadores de una distrofia corneal con debilitamiento estructural corneal y pérdida consecutiva de visión, dentro del marco de un ensayo clínico fase I-IIa.
    E.2.2Secondary objectives of the trial
    • To demonstrate the increase of the corneal thickness after the implantation of ADASCs and/or decellularized corneal sheet.
    • To demonstrate that there is a biological activation of the corneal stroma after the implantation of ADASCs and/or decellularized corneal sheet.
    • To evaluate the biomechanical characteristics of the eye operated after treatment with the cellular implant (ADASCs) and/or decellularized corneal sheet.
    • Investigate the changes that occur in the corneal refraction of these patients in topographic and aberrometric terms.
    • Demonstrate that there is an increase in vision and visual acuity of the patients treated in this way in relation to the use of the cellular implant used.
    • Demostración del incremento en el espesor corneal tras el implante de ADASCs y/o lámina corneal descelularizada.
    • Demostrar que existe una activación biológica del estroma corneal tras el implante de ADASCs y/o lámina corneal descelularizada.
    • Evaluar las características biomecánicas del ojo operado tras el tratamiento con el implante celular (ADASCs) y/o lámina corneal descelularizada.
    • Investigar los cambios que ocurren en la refracción corneal de estos pacientes en términos topográficos y aberrométricos.
    • Demostrar que existe un incremento de la visión y agudeza visual de los pacientes así tratados en relación con el empleo del implante celular utilizado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients affected by corneal stromal dystrophies of any type, but particularly keratoconus, showing clear evidence in the ophthalmic examination of the presence and clear expression of the disease and loss of vision as a result of it.
    • Age: = 18-60 years.
    • Patients with best corrected visual acuity less than 0.6.
    • Absence of chronic or recurrent inflammation in the anterior segment and on the ocular surface.
    • Patient able to undergo corneal graft surgery with local anesthesia, from the medical point of view.
    • Normal Pre-surgical analyses of serum biochemistry and hematology.
    • Negative serology for Human Immunodeficiency Virus (HIV), hepatitis B (HBV), and hepatitis C (HCV).
    • No history of malignant disease.
    • Normal chest X-ray (Rx).
    • Normal urine analysis.
    • Normal thyroid test.
    • Pacientes afectados de distrofias del estroma corneal de cualquier tipo, pero particularmente queratocono, mostrando evidencia clara en el examen oftálmico de la presencia y clara expresión de la enfermedad y pérdida de visión a consecuencia de la misma.
    • Edad: = 18-60 años.
    • Pacientes con agudeza visual mejor corregida menor de 0.6.
    • Ausencia de inflamación crónica o recurrente en el segmento anterior y en la superficie ocular.
    • Paciente apto para someterse a cirugía de injerto corneal con anestesia local, desde el punto de vista médico.
    • Analíticas pre-quirúrgicas de bioquímica sérica y hematología normales.
    • Serología para Virus de la inmunodeficiencia humana (VIH), hepatitis B (VHB), y hepatitis C (VHC) negativa.
    • No historia de enfermedad maligna.
    • Radiografía de tórax normal (Rx).
    • Análisis de orina normal.
    • Examen tiroides normal.
    E.4Principal exclusion criteria
    • Dense and extensive corneal stromal scars with severe involvement of the visual axis and located in the pupillary area, causing a decrease in the best corrected vision at levels of 0.1 or less.
    • Distant vision corrected with glasses of 0.7 or greater.
    • Extreme corneal thinning with risk of perforation.
    • Infection.
    • Previous corneal surgeries.
    • Moderate or severe dry eye.
    • Moderate or severe chronic inflammatory pathology of the ocular surface.
    • Prior ocular surgery other than cataract.
    • Presence of a cataract or other severe opacity of the transparent media of the eye that could impede the proper examination of the fundus.
    • Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of ocular topical medication.
    • Known and severe coagulation abnormalities.
    • Any medical condition that may interfere causing serious adverse effects during the study.
    • Presence of active or inactive corneal neovascularization (CNV) in the eye to be treated
    • Any immunodeficiency or systemic autoimmune disease.
    • Any current or intermittent immunosuppressive therapy or low doses of corticosteroids.
    • Renal insufficiency, defined by creatine value >1.3 mg / dL.
    • Serological evidence of infection due to hepatitis B, hepatitis C or HIV.
    • Pregnant or lactating woman.
    • Correct visual acuity in the eye contralateral to the experimental smaller than 20/40 (0.5).
    • Cicatrices estromales corneales densas y extensas con afectación severa del eje visual y situados en el área pupilar, causando disminución de la mejor visión corregida a niveles de 0.1 o menores.
    • Visión corregida de lejos con gafas de 0.7 o mayor.
    • Adelgazamiento corneal extremo con riesgo de perforación.
    • Infección.
    • Previas cirugías corneales.
    • Ojo seco moderado o severo.
    • Patología inflamatoria crónica moderada o severa de la superficie ocular.
    • Cirugía ocular previa distinta de catarata.
    • Presencia de catarata u otro tipo de opacidad severa de los medios transparentes del ojo que pudiera impedir el examen adecuado del fondo de ojo.
    • Otra comorbilidad oftálmica como glaucoma o uveítis o cualquiera que exija el uso crónico de medicación tópica ocular.
    • Anomalías conocidas y severas de la coagulación.
    • Cualquier condición médica que pueda interferir causando efectos adversos graves durante el estudio.
    • Presencia de neovascularización corneal activa o inactiva (NVC) en el ojo a tratar
    • Cualquier inmunodeficiencia o enfermedad autoinmune sistémica.
    • Cualquier terapia inmunosupresora actual o intermitente o bajas dosis de corticoides.
    • Insuficiencia renal, definida por valor de creatina > 1,3 mg/dL.
    • Evidencia serológica de infección por hepatitis B, hepatitis C o VIH.
    • Mujer embarazada o en período de lactancia.
    • Agudeza visual corregida en el ojo contralateral al experimental menor a 20/40 (0.5).
    E.5 End points
    E.5.1Primary end point(s)
    Uncorrected visual acuity and best corrected distance visual acuity: These visual acuities will be evaluated in each post-operative visit in order to quantify the recovery of vision over time. When appropriate, the visual acuity associated with rigid gas permeable contact lens will also be evaluated.
    Agudeza visual no corregida y Agudeza Visual Mejor corregida de lejos: Se evaluarán en cada visita post operatoria estas agudezas visuales a fin de cuantificar la recuperación de la visión a lo largo del tiempo. Cuando proceda se evaluará también la agudeza visual asociada a lente de contacto rígida gas permeable.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening visit, day 1, month 1, month 3, month 6, and month 12
    Visita de selección. día 1, mes 1, mes 3, mes 6 y mes 12.
    E.5.2Secondary end point(s)
    • Refraction
    • Biomicroscopic integration
    • High resolution Corneal Topography and Corneal Aberrometry
    • Corneal thickness
    • Optical coherence tomography of the anterior segment
    • Total ocular Aberrometry
    • Corneal biomechanics
    • Confocal microscopy
    • Medida de la refracción
    • Integración biomicroscópica
    • Topografía Corneal de alta resolución y Aberrometria Corneal
    • Espesor Corneal
    • Tomografía de coherencia óptica del segmento anterior
    • Aberrometría ocular total
    • Biomecánica corneal
    • Microscopia Confocal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening visit, day 1, month 1, month 3, month 6, and month 12
    Visita de selección. día 1, mes 1, mes 3, mes 6 y mes 12.
    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) 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    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
    LVLS
    Última visita del último 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 months
    E.8.9.1In the Member State concerned days
    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) 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 state30
    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)
    After one year of follow-up, the patient should have a stable situation that does not require any kind of special treatment
    Tras un año de seguimiento, el paciente debería tener una situación estable que no requiera ningún tipo de tratamiento especial.
    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 Decision2021-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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