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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001596-36
    Sponsor's Protocol Code Number:bcthug11
    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:2012-04-26
    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 number2012-001596-36
    A.3Full title of the trial
    Application of Mesenchymal Stem Cells and full of plasma in the management of the burn wound in patients with large burn injury
    Aplicación de células madre mesenquimales y plasma rico en plaquetas en el tratamiento de las heridas del paciente gran quemado

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tratamiento de quemaduras mediante aplicación de células madre
    A.3.2Name or abbreviated title of the trial where available
    Stem Cells
    Células madre
    A.4.1Sponsor's protocol code numberbcthug11
    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 SponsorMIGUEL CASARES FERNÁNDEZ-ALVÉS
    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 supportMIGUEL CASARES FERNÁNDEZ-ALVÉS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMIGUEL CASARES FERNÁNDEZ-ALVÉS
    B.5.2Functional name of contact pointMiguel Casares
    B.5.3 Address:
    B.5.3.1Street AddressCARRETERA DE TOLEDO Km 12.5
    B.5.3.2Town/ cityGetafe _ Madrid
    B.5.3.3Post code28905
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916839360 2447
    B.5.5Fax number+34916967114
    B.5.6E-mailmcasares.hugf@salud.madrd.org
    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 MADRE MESENQUIMALES DERIVADAS DE TEJIDO ADIPOSO
    D.3.2Product code ADMSC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeADMSC, e-ASC
    D.3.9.3Other descriptive nameCélulas Madre Mensenquimales
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3000000 to 8000000
    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 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 namePLASMA RICO EN PLAQUETAS
    D.3.2Product code PRP
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePRP
    D.3.9.3Other descriptive namePLASMA RICO EN PLAQUETAS
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tratamiento de las heridas por quemadura con ADMSC
    E.1.1.1Medical condition in easily understood language
    Tratamiento de quemaduras con células madres
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    • Demostrar que el coágulo de fibrina formado a partir del PRP es un buen soporte para las ADMSC y que su aplicación es sencilla.
    • Demostrar la influencia de los factores de crecimiento del PRP sobre la supervivencia y proliferación de las ADMSC en la lesión por quemadura.
    E.2.2Secondary objectives of the trial
    • Comprobar el papel regenerativo del combinado ADMSC+PRP sobre un lecho quirúrgico tras lesiones por quemadura:
    - Acelera el proceso de cicatrización.
    - Estimula la aparición de neodermis.
    - Mejora el aspecto estético y funcional de las heridas por quemadura.
    • Valorar si la cicatrización de la herida es debido al efecto de las ADMSC o debido a un efecto sinérgico de las ADMSC y el PRP.
    • Seleccionar las curas (apósitos, soluciones antibióticas/antisépticas) que se demuestren más adecuadas para la conservación/prendimiento de los injertos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes que ingresen en el Servicio de Cirugía Plástica del HUG que cumplan las siguientes condiciones:
    - Pacientes mayores de 18 años.
    - Con quemaduras dérmicas totales que requieran injertos mallados 3x1, según valoración del Cirujano Plástico.
    - Que acepten participar en el estudio tras recibir la información adecuada.
    E.4Principal exclusion criteria
    - Pacientes que así lo soliciten.
    - Pacientes en los que, por cualquier motivo (contaminación de la biopsia, problemas técnicos, muerte celular), no se consiga el volumen celular adecuado o no se disponga del medicamento en el momento de la intervención.
    - Pacientes con deterioro hemodinámico o clínico severo (Infección, Sepsis).
    E.5 End points
    E.5.1Primary end point(s)
    Tiempo hasta la cicatrización. Es el tiempo que se tarda en conseguir un cierre del autoinjerto mallado del 90%
    E.5.1.1Timepoint(s) of evaluation of this end point
    no definido
    E.5.2Secondary end point(s)
    • Porcentaje de epitelización del injerto a los días 2, 5, 7 y 14.
    • Causas y porcentaje de pérdida del injerto:
    a-infección
    b-movilización del injerto
    c-presencia de hematomas
    d-otras
    • Valoración estética y funcional (días 14, 30 y 90): De acuerdo con la escala de Vancouver1
    • Valoración estética y funcional final (6 meses): de acuerdo con la escala POSAS2 (Patient and Observer Scar Assessment Scale). La evaluación de la situación de la cicatriz es realizada por un observador y por el propio paciente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Porcentaje de epitelización del injerto a los días 2, 5, 7 y 14.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Medicamento y placebo se utilizan en el mismo paciente y al mismo tiempo
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Se hará seguimiento: Hasta un año después de finalizada la recogida de datos o por el tiempo que se determine en caso de presencia de secuelas
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state23
    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)
    Se monitorizará la presencia o no de efectos adversos en cada revisión buscando la presencia de tejidos anómalos, existencia de signos inflamatorios persistentes o cualquier otro signo que sugiera un efecto dañino de las ADMSC. En caso de sospecha, se realizará el estudio histológico para determinar la naturaleza de la afectación y será diferente del establecido en el protocolo.
    Esta monitorización se prolongará hasta un año después de finalizado el estudio o más si se considera necesario.
    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 Decision2012-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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