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    Summary
    EudraCT Number:2021-005486-40
    Sponsor's Protocol Code Number:CELOPHIN
    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:2022-02-11
    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 number2021-005486-40
    A.3Full title of the trial
    Phase IIa multicenter clinical trial to determine the feasibility and safety of the use of adipose-derived mesenchymal stem cells (ASC) in the treatment of patients with cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson syndrome and pemphigoid of the mucous membranes with ocular involvement.
    Ensayo clínico en fase IIa multicéntrico para conocer la factibilidad y seguridad del uso de células troncales mesenquimales derivadas del tejido adiposo (ASC) en el tratamiento de pacientes con conjuntivitis cicatriciales asociadas a Síndrome de Lyell, síndrome Stevens- Johnson y Penfigoide de las membranas mucosas con afectación ocular.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to evaluate safety and efficacy of cell therapy in patients with cicatricial conjuntivitis
    Ensayo Clínica para evaluar la seguridad y eficacia de la terapia celular en pacientes con conjuntivitis cicatriciales
    A.3.2Name or abbreviated title of the trial where available
    CELOPHIN
    A.4.1Sponsor's protocol code numberCELOPHIN
    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 SponsorFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    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 supportFundación Jiménez Díaz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.5.2Functional name of contact pointCLINICAL RESEARCH UNIT
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Reyes Católicos 2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number00349155048003214
    B.5.5Fax number0034915505353
    B.5.6E-mailmireia.arcas@fjd.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 nameallogenic mesenchymal stem cell isolated from adipose tissue
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Subconjunctival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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 RoleComparator
    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 nameallogenic mesenchymal stem cell isolated from adipose tissue
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Subconjunctival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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
    Cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson syndrome and mucous membrane pemphigoid with ocular involvement.
    Conjuntivitis cicatriciales asociadas a síndrome de Lyell, síndrome Stevens- Johnson y Penfigoide de las membranas mucosas con afectación ocular.
    E.1.1.1Medical condition in easily understood language
    Conjunctivitis
    Conjuntivitis
    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
    To evaluate the safety and tolerability of the administration of allogenic mesenchymal cells derived from adipose tissue in diabetic patients with critical ischemia of the lower limbs.
    evaluar la seguridad y tolerabilidad de la administración de células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas en pacientes diabéticos con isquemia crítica de miembros inferiores
    E.2.2Secondary objectives of the trial
    -To evaluate the preliminary efficacy of the treatment.
    - To evaluate the quality of life after the administration of the treatment.
    - To evaluate immunological changes
    - Evaluar la eficacia preliminar del tratamiento
    - Evaluar los cambios en la calidad de vida de los pacientes
    - Evaluar cambios inmunológicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women over 18 years of age.
    2. Diagnosis of ocular pemphigoid in Foster stages I-IIcIIIb (2) or diagnosis of recurrent chronic or episodic inflammation accompanied by cicatricial conjunctivitis of the mucous membranes with ocular involvement after the acute phase of Stevens-Johnson Syndrome or Lyell Syndrome .
    3. In the case of women of childbearing age, who are willing to use an effective contraceptive method during the period of participation in the study
    4. Consent to participate and signature of the informed consent
    1. Hombres y mujeres mayores de 18 años.
    2. Diagnóstico de penfigoide ocular en estadíos I-IIcIIIb (2) de Foster o diagnóstico de inflamación crónica o episódica recurrente acompañada de conjuntivitis cicatricial de las membranas mucosas con afectación ocular tras la fase aguda de un Síndrome de Stevens-Johnson o Síndrome de Lyell.
    3. En caso de mujeres en edad fértil, que estén dispuestas a utilizar un método anticonceptivo eficaz durante el periodo de participación en el estudio
    4. Consentimiento para participar y firma del consentimiento informado
    E.4Principal exclusion criteria
    1. Signs of active infection on the ocular surface.
    2. History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma
    3. Allergy to local anesthetics
    4. Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC
    5. Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
    6. Congenital or acquired immunodeficiencies.
    7. Major surgery or serious trauma of the subject in the semester prior to signing the IC.
    8. Pregnant or lactating women.
    9. Impossibility or refusal to carry out the follow-up required in the study by the patient
    1. Signos de infección activa en la superficie ocular.
    2. Historial de neoplasias en los últimos 5 años. a excepción de carcinoma epitelial de células basales o escamosas
    3. Alergia a anestésicos locales
    4. Pacientes que hayan participado en otro ensayo clínico con medicamento durante los 90 días previos a la firma del CI
    5. Enfermedad médica o psiquiátrica de cualquier tipo que, en opinión del investigador, pueda suponer un motivo de exclusión del estudio.
    6. Inmunodeficiencias congénitas o adquiridas.
    7. Cirugía mayor o traumatismo grave del sujeto en el semestre anterior a la firma del CI.
    8. Mujeres embarazadas o lactantes.
    9. Imposibilidad o negación a realizar el seguimiento requerido en el estudio por parte del paciente
    E.5 End points
    E.5.1Primary end point(s)
    According to the primary objective of the study, the following variables are defined:
    o Percentage and type of complications arising from treatment:
    o Complications during anesthesia.
    o Complications during cell implantation.
    o Peri and postoperative complications.
    - Porcentaje y tipo de complicaciones debidas al tratamiento.
    - Complicaciones durante la anestesia.
    - Complicaciones durante el implante celular.
    - Complicaciones peri y post operatorias
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 7 days (and 21 days in the 2-dose group), 4 weeks, 12w, 24w and 52 weeks
    A los 7 días (y 21 días en grupo 2 dosis), 4 semanas 12s, 24s y 52 semanas
    E.5.2Secondary end point(s)
    -Evaluate the preliminary efficacy of the treatment in terms of:
    o Improvement of signs (scarring conjunctivitis rating scale)
    o Symptom improvement (OSDI questionnaire)
    o VA improvement (EDTRS)

    -Assess the changes in quality of life with respect to baseline using the specific NEI-VFQ questionnaire 25

    -Determine the evolution of the conjunctival flora of patients after being treated by applying ASC to the ocular surface and evaluate the effect of the treatment (to see if there is any type of immunomodulation)
     Evaluar la eficacia preliminar del tratamiento en términos de:
    o Mejoría de los signos (escala de valoración de conjuntivitis cicatricial)
    o Mejoría de los síntomas (cuestionario OSDI)
    o Mejoría de la AV (EDTRS)

     Evaluar los cambios en la calidad de vida respecto a la situación basal mediante el cuestionario específico NEI-VFQ 25

     Determinar la evolución de la flora conjuntival de los pacientes tras ser tratados mediante la aplicación ASC en la superficie ocular y evaluar el efecto del tratamiento (para ver si hay algún tipo de inmunomodulación)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 7 days (and 21 days in the 2-dose group), 4 weeks, 12w, 24w and 52 weeks
    A los 7 días (y 21 días en grupo 2 dosis), 4 semanas 12s, 24s y 52 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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    DOSE RANGING STUDY, WITH 2 CONSECUTIVE COHORTS, ONE SINGLE DOSE AND ONE 2 DOSES
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SAME MEDICINAL PRODUCT, ONE MORE DOSE
    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 concerned8
    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
    Last patient Last visit
    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 months20
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    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. Patients will be managed according to local standard of care after the end of the trial.
    Los pacientes será manejados de acuerdo a practica clinica habitual tras el fin del estudio
    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 Spanish Clinical Research Network
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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