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    Summary
    EudraCT Number:2011-004395-11
    Sponsor's Protocol Code Number:MA/GH
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-27
    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 number2011-004395-11
    A.3Full title of the trial
    PHASE I/II CLINICAL TRIAL ON THE USE OF THE AMNIOTIC MEMBRANE FOR LARGE WOUND EPITHELIZATION
    ENSAYO CLÍNICO EN FASE I/II DE UTILIZACIÓN DE MEMBRANA AMNIÓTICA PARA LA EPITELIZACIÓN DE GRANDES HERIDAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE I/II CLINICAL TRIAL ON THE USE OF THE AMNIOTIC MEMBRANE FOR LARGE WOUND EPITHELIZATION
    ENSAYO CLÍNICO EN FASE I/II DE UTILIZACIÓN DE MEMBRANA AMNIÓTICA PARA LA EPITELIZACIÓN DE GRANDES HERIDAS
    A.4.1Sponsor's protocol code numberMA/GH
    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 SponsorFundación para la Formación e Investigación Sanitarias de la Región de Murcia
    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 supportMinisterio de Sanidad Servicios Sociales e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Virgen de la Arrixaca
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Madrid Cartagena SN
    B.5.3.2Town/ cityMurcia
    B.5.3.3Post code30120
    B.5.3.4CountrySpain
    B.5.4Telephone number34968381290
    B.5.5Fax number34968381289
    B.5.6E-mailisabel.vasallo@carm.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 nameAM placed over an impregnated dressing of Tulgrasum. Membrana amniótic sobre un apósito de Tulgrasum
    D.3.4Pharmaceutical form Impregnated dressing
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNamniotic membrane
    D.3.9.2Current sponsor codeMA
    D.3.10 Strength
    D.3.10.1Concentration unit cm2 square centimeter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product type"Borderline" Advanced Therapy IMP Producto "bordeline" calificado como medicamento de terapias avanzadas
    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
    extensive wounds
    Grandes heridas
    E.1.1.1Medical condition in easily understood language
    extensive wounds
    Grandes heridas
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10062932
    E.1.2Term Wound treatment
    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 analyze the safety of the application of the AM in extensive wounds in the granulation phase.
    Analizar la seguridad de la aplicación de la MA en grandes heridas en fase de granulación.
    E.2.2Secondary objectives of the trial
    To assess the effects of the application of the AM on the reepithelization of wounds through the reduction over time of the area unit of the wound
    To assess the effects of AM application for treating patient symptomatology through the evolution of local pain through a visual analogue scale
    To study changes in the signally pathways of TGF? in the epithelium of patients included for AM.
    Evaluar los efectos de la aplicación de la MA sobre la reepitelización de las heridas mediante la medición del área de la herida.

    Evaluar los efectos de la aplicación de la MA en la sintomatología de los pacientes mediante la evolución del dolor local medido con una escala analógica visual.

    Estudiar los cambios en las vías de señalización de TGFB en el epitelio de los pacientes inducidos por la MA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Acute wounds in the granulation phase with a minimum surface of 100 cm2.
    Patients who are 18 or older.
    Patients who offer enough guarantees of adhesion to the protocol.
    Patients who have signed informed consent.
    Heridas agudas en fase de granulación con una superficie mínima de 100 cm2.
    Pacientes de 18 o más años.
    Pacientes que ofrezcan garantías suficientes de adhesión al protocolo.
    Firmar el consentimiento informado.
    E.4Principal exclusion criteria
    Patients who have symptomatic chronic artery failure.
    Patients with severe systematic diseases.
    Diabetic patients.
    Inclusion in other clinical trials.
    Inability to understand informed consent.
    Pacientes que presenten insuficiencia arterial crónica sintomática.
    Pacientes con enfermedades sistémicas severas.
    Pacientes diabéticos.
    Inclusión en otros ensayos clínicos.
    Incapacidad de comprender el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Absence of severe adverse events related in any possible, probable or certain way with the procedure.
    Absence of clinical inflamatoy changes
    Ausencia de acontecimientos adversos severos con relación posible, probable o segura con el procedimiento.
    No aparición de cambios inflamatorios clínicos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After positioning each AM, the wound will be controlled at day four. After positioning the final AM a control visit will be carried out every 7 days for 3 months and afterwards every 3 months until 1 year of evolution time has passed
    La herida se controlará a los cuatro días después de la aplicación de cada MA, y posteriormente cada 7 días durante 3 meses. Después, el control se realizará cada 3 meses hasta un 1 año de evolución.
    E.5.2Secondary end point(s)
    ? Wound Assessment: Clinical assessment carried out by the specialist in Surgery:
    ? Inflammatory state of the wound.
    ? Redness (yes/no).
    ? Flushing (yes/no).
    ? Inflammatory tumor (yes/no).
    ? State of perilesional skin (normal/abnormal).
    ? Appearance of local neoplasias (yes/no).
    ? Assessment of symptoms related with the wound
    ? Local pain assessed using the visual analogue scale between 0 and 10, 0 being no pain and 10 the worst pain possible.
    ? Analgesic required classified into 3 stratum, according to the analgesic scale of the WHO.
    ? Immunological Assessment
    ? Detection of class I HLA anti-bodies (present/absent)
    ? Chimerism of the wound through detection of STRs (% donor/% recipient)
    ? Histological Assessment
    ? Anatomopathological Assessment of seried biopsies of the wound and the re-epithelization border.
    ? Analysis of the TGF? signalling pathway in the same biopsies.
    ? Microbiological Assessment
    ? Microbiological cultivation on the wound surface (positive/negative).
    ? Evaluación de la herida
    - Evaluación clínica realizada por el especialista en Cirugía: estado inflamatorio de la herida.
    o Rubor (si/no).
    o Calor (si/no).
    o Tumor inflamatorio (si/no).
    - Área de la herida (cm2).
    - Estado de la piel perilesional (normal/anormal).
    - Aparición de neoplasias locales (si/no).

    ? Evaluación de los síntomas relacionados con la herida
    - Dolor local valorado mediante escala analógica visual entre 0 y 10, siendo 0 no dolor y 10 el peor dolor imaginable.
    - Analgesia requerida clasificada en 3 estratos, según el escalonamiento analgésico de la OMS.

    ? Evaluación inmunológica
    - Detección de anticuerpos anti HLA de clase I (presentes/ausentes)
    - Quimerismo de la herida mediante detección de STRs (% donante/% receptor)

    ? Evaluación histológica
    - Estudio anatomopatológico de biopsias seriadas de la herida y del borde de reepitelización.
    - Estudio de la vía de señalización de TGF? en las mismas biopsias.

    ? Evaluación microbiológica
    - Cultivo microbiológico de la superficie de la herida (positivo/negativo).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After positioning the final AM a control visit will be carried out every 7 days for 3 months and afterwards every 3 months until 1 year of evolution time has passed. All secondary endpoints will be controlled.
    Se realizará una visita de seguimiento cada 7 días durante 3 meses. Después, el control se realizará cada 3 meses hasta un 1 año de evolución. En cada visita se controlarán todas las variables secundarias
    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) 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    The end of the trial is the last visit of the last subject undergoing the trial.
    El final del ensayo coincide con la íltima visita del ultimo sujeto participante en el ensayo.
    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 months0
    E.8.9.1In the Member State concerned 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state10
    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)
    Treatment of cares after the subject has ended the participation in the trial is not different from the expected normal teatment of total condition.
    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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
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