Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004140-32
    Sponsor's Protocol Code Number:PRP-MUSCULO-2014-01
    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:2013-12-05
    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 number2013-004140-32
    A.3Full title of the trial
    CLINICAL STUDY TO ASSES THERAPEUTIC USE OF PLATELET RICH PLASMA IN ACUTE MUSCLE INJURIES IN ELITE ATHLETES"
    ?ESTUDIO CLÍNICO SOBRE EL USO TERAPÉUTICO DEL PLASMA RICO EN
    PLAQUETAS EN LESIONES MUSCULARES AGUDAS EN DEPORTISTAS DE ALTO RENDIMIENTO?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "STUDY TO ASSES A DERIVATIVE HEMATOLOGIC TREATMENT IN ACUTE MUSCLE INJURIES IN ELITE ATHLETES"
    ?ESTUDIO SOBRE EL USO DE UN TRATAMIENTO CON UN DERIVADO HEMATOLOGICO EN LESIONES MUSCULARES AGUDAS EN DEPORTISTAS DE ALTO RENDIMIENTO"
    A.3.2Name or abbreviated title of the trial where available
    USE OF PLATELET RICH PLASMA IN ACUTE MUSCLE INJURIES
    USO DE PLASMA RICO EN PLAQUETAS EN LESIONES MUSCULARES AGUDAS
    A.4.1Sponsor's protocol code numberPRP-MUSCULO-2014-01
    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 SponsorUnidad de Cirugia Artroscópica
    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 supportOSAKIDETZA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSAKIDETZA
    B.5.2Functional name of contact pointJORGE GUADILLA ARSUAGA
    B.5.3 Address:
    B.5.3.1Street AddressC/LUIS POWER 18 4ºPL
    B.5.3.2Town/ cityBILBAO
    B.5.3.3Post code48014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034946006637
    B.5.5Fax number0034946006639
    B.5.6E-mailjavi.g.iglesias@gmail.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 namePRP (OBTENIDO POR PRGF-ENDORET)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRGF-ENDORET
    D.3.9.3Other descriptive nameAUTOLOGOUS PLASMA
    D.3.9.4EV Substance CodeSUB117286
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 15
    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) No
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Muscle Injury Type 3A-3B (Munich classification) or type II (Classification of Otto Chan), confirmed by radiological diagnosis and clinical agreement.
    Lesión muscular aguda tipo 3A-3B (clasificación de Munich) o tipo II (Clasificación de Otto Chan), confirmada mediante diagnóstico radiológico, y concordancia clínica.
    E.1.1.1Medical condition in easily understood language
    Acute Muscle Injury
    Lesion muscular aguda
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10028391
    E.1.2Term Musculoskeletal pain
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    OBJECTIVES
    main Objectives
    ? To evaluate the short-term efficacy of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the number of days that elapse from the onset of the injury until returning to sporting competition in each of the groups.
    ? To evaluate the short-term safety of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the percentage of adverse reactions collected in each of the groups.
    ? Evaluation of the number of relapses after an acute muscle injury grade II in the intervention group compared to control.
    OBJETIVOS
    Objetivos principales
    ? Evaluar la eficacia a corto plazo de la infiltración intramuscular (guiada por ecografía) de PRP más fisioterapia frente a la infiltración de Traumeel® más fisioterapia, en el tratamiento de las lesiones musculares agudas grado II, mediante la medida del número de días que transcurren desde la aparición de la lesión hasta la vuelta a la competición deportiva, en cada uno de los grupos.
    ? Evaluar la seguridad a corto plazo de la infiltración intramuscular (guiada por ecografía) de PRP más fisioterapia frente a la infiltración de Traumeel® más fisioterapia, en el tratamiento de las lesiones musculares agudas grado II, mediante la medida del porcentaje de reacciones adversas recogidas en cada uno de los grupos.
    ? Evaluación del número de recidivas tras una lesión muscular aguda grado II en el grupo intervención frente al control.
    E.2.2Secondary objectives of the trial
    ? Establish a prognostic index LEZAMA called INDEX. For this the end of the study aims to establish a prognostic value in DAYS recovery period in severe acute muscle injury (grade II), treated with 2 injections of PRP, and taking into account the following variables: the muscle group affected location frequency, radiological imaging, force mobility, pain, and functional self-perception.
    ? Composition of PRP: help establish the best composition of the PRP, by analyzing different molecules directly involved in muscle repair (standardization of formulations).
    ? description radiological evolution of muscle injury and repair quality through serial MRI.
    ? Found data will be compared with the historical group of the last decade of the different teams, and in relation to the data published in the scientific literature.
    ? Establecer un índice pronóstico llamado ÍNDICE LEZAMA. Para ello al finalizar el estudio, se pretende establecer un valor pronóstico en DÍAS del período de recuperación en una lesión muscular aguda severa (grado II), tratada con 2 infiltraciones de PRP y teniendo en cuenta las siguientes variables: el grupo muscular afectado, localización, frecuencia, imagen radiológica, fuerza movilidad, dolor y autopercepción funcional.
    ? Composición del PRP: ayudar a establecer la mejor composición del PRP, mediante el análisis de distintas moléculas implicadas directamente en la reparación muscular (estandarización de formulaciones).
    ? Descripción de la evolución radiológica de la lesión muscular y la calidad de la reparación mediante las RMN seriadas.
    ? Se compararán los datos encontrados con el grupo histórico de la última década de los distintos equipos, y en relación con los datos publicados en la literatura científica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Over 18 years.
    - Acute Muscle Injury Type 3A-3B (Munich classification) or type II (Classification of Otto Chan), confirmed by radiological diagnosis and clinical agreement.
    - Informed consent. Rated and signed.
    - Mayores de 18 años.
    - Lesión muscular aguda tipo 3A-3B (clasificación de Munich) o tipo II (Clasificación de Otto Chan), confirmada mediante diagnóstico radiológico, y concordancia clínica.
    - Consentimiento informado. Valorado y firmado.
    E.4Principal exclusion criteria
    - prior infiltration of corticosteroids or plasma for hamstring or quadriceps in the 6 months prior to baseline.
    - Infiltración previa de corticoides o plasma en isquiosurales o cuadriceps en los 6 meses previos al inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    RECOVERY PERIOD . Days since muscle injury to return to full training with the rest of the class . For this, the
    player will be evaluated by the physician previously at the clinical reference to establish if it meets the criteria for discharge .
    - Size of the muscle injury . Quantitative evaluation of the lesion evolution .
    RELAPSES . Injury incident again treated muscle group .
    First episode : the absence of injury objectified / player asymptomatic in the last half year in the affected muscle group .
    Relapse: objectified injury / pain clinic maintained (at least for a week ) in the last six months in the affected muscle group .
    Two tests are performed imaging ( MRI) to measure the evolution of the lesion size .
    - Strength: isokinetic assessment . The force exerted by the muscle group injured in concentric contraction as a predictor of functional recovery.
    Comparison of the data with respect to the contralateral leg .
    - Mobility . Range of motion in relation to the parameters of the contralateral leg .
    - Pain . It makes an assessment of pain by visual analog scale versus exploration, as local tenderness and muscle contraction . First leg is done in healthy , so that the player is familiar with the
    scan.
    - Review of self-perception. Self-Perception Questionnaire athlete training for a return to normal after injury.
    ANALYSIS OF PLATELET AND SIGNALING MOLECULES
    - PLATELETS . Concentration of platelets in peripheral blood and plasma
    infiltrated .
    - HGF. Satellite cell activation . Maximum action in regenerative phase ( early days ) . Concentration and plasma total amount infiltrated
    - IGF-1. Satellite cell activation and formation of myoblasts . Increased action on cell differentiation phase (after several days). Concentration and plasma total amount infiltrated
    - TGF - Beta 1 . Promotes angiogenesis and myoblast fusion , stimulating or inhibiting satellite cells by interaction with other factors .
    Concentration and plasma total amount infiltrated .
    - PF -4 . Activation of fibroblast migration . Main signaling molecule in quantity . Concentration and plasma total amount infiltrated .
    - BDNF ( Brain Derived neurotropic factor ) . Regulation of the function and satellite cell regeneration . Concentration and plasma total amount infiltrated .
    - Other : VEGF , PDGF
    reincorporación al entrenamiento normalizado tras lesión.
    PERIODO DE RECUPERACIÓN. Días transcurridos desde la lesión muscular hasta la reincorporación a la totalidad del entrenamiento con el resto de compañeros. Para ello, el
    jugador será valorado previamente por el médico en el centro clínico de referencia, para establecer si cumple los criterios de alta.
    - Tamaño de la lesión muscular. Evaluación cuantitativa de la evolución de la lesión.
    RECIDIVAS. Lesión que incide nuevamente en un grupo muscular tratado.
    Primer episodio: ausencia de lesión objetivada / jugador asintomático en el último medio año en el grupo muscular afecto.
    Recidiva: lesión objetivada / clínica de dolor mantenida (al menos durante una semana) en los últimos seis meses en el grupo muscular afecto.
    Se realizan dos pruebas de diagnóstico por imagen (resonancia magnética) para medir el tamaño evolutivo de la lesión.
    - Fuerza: valoración isocinética. La fuerza ejercida por el grupo muscular lesionado en contracción concéntrica como valor predictivo de recuperación funcional.
    Comparativa de los datos respecto a la pierna contralateral.
    - Movilidad. Rango de movilidad en relación con los parámetros de la pierna contralateral.
    - Dolor. Se realiza una valoración del dolor mediante la Escala Analógica Visual frente a la exploración, en cuanto la palpación local y a la contracción muscular. En primer lugar se realiza en la pierna sana, para que el jugador se familiarice con la
    exploración.
    - Test de autopercepción. Cuestionario de autopercepción del deportista para la reincorporación al entrenamiento normalizado tras lesión.
    ANÁLISIS DE PLAQUETAS Y MOLÉCULAS DE SEÑALIZACIÓN
    - PLAQUETAS. Concentración de plaquetas en sangre periférica y en plasma
    infiltrado.
    - HGF. Activación de células satélite. Máxima acción en la fase regenerativa (primeros días). Concentración y cantidad total en el plasma infiltrado
    - IGF-1. Activación de células satélites y formación de mioblastos. Mayor acción en la fase de diferenciación celular (tras varios días). Concentración y cantidad total en el plasma infiltrado
    - TGF-Beta 1. Favorece la angiogénesis y la fusión de mioblastos, estimulando o inhibiendo las células satélites según su interacción con otros factores.
    Concentración y cantidad total en el plasma infiltrado.
    - PF-4. Activación de la migración de los fibroblastos. Principal molécula de señalización en cuanto a cantidad. Concentración y cantidad total en el plasma infiltrado.
    - BDNF (Brain Derived Neurotropic Factor). Regulación de la función y regeneración de las células satélites. Concentración y cantidad total en el plasma infiltrado.
    - Otras: VEGF, PDGF
    E.5.1.1Timepoint(s) of evaluation of this end point
    Quadriceps: Baseline and after 10 days. If the lesion requires: 13,16 or 19 days
    Hamstrings: Basal, at 18 days. If the lesion requires: 21,24 or 27
    Cuadriceps: Basal, a los 10 dias. Si la lesion los requiere a 13,16 o 19 dias Isquiotibiales: Basal, a los 18 dias . si la lesion lo requieres 21,24 o 27 dias
    E.5.2Secondary end point(s)
    Record any iatrogenic
    Registro de cualquier tipo de yatrogenia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quadriceps: Baseline and after 10 days. If the lesion requires: 13,16 or 19 days
    Hamstrings: Basal, at 18 days. If the lesion requires: 21,24 or 27
    Cuadriceps: Basal, a los 10 dias. Si la lesion los requiere a 13,16 o 19 dias Isquiotibiales: Basal, a los 18 dias . si la lesion lo requieres 21,24 o 27 dias
    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 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 No
    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 No
    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
    When the patient is fully recovered from the injury and return to play
    Cuando el paciente este totalmente recuprado de la lesion
    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 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: 64
    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 state64
    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)
    No
    No
    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 Decision2014-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-31
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 10:53:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA