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    Summary
    EudraCT Number:2017-000623-27
    Sponsor's Protocol Code Number:EC_01_2017
    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:2017-06-20
    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 number2017-000623-27
    A.3Full title of the trial
    Role of autologous biological therapy in knee osteoarthritis. Intraosseous application of plasma rich in growth factors , improve of functional capacity and pain, compared to intraarticular application.
    Papel de la terapia biológica en la artrosis de rodilla. Aplicación intraósea del plasma rico en factores de crecimiento, mejora de la capacidad funcional y el dolor en comparación con la aplicación intraarticular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intraarticular and intraosseus application of plasma rich in growth factors in patients with knee osteoarthritis to improve movility and pain
    Comparación de la aplicación intraarticular e intraósea del plasma rico en factores de crecimiento en pacientes con artrosis de rodilla para mejorar la movilidad y el dolor.
    A.4.1Sponsor's protocol code numberEC_01_2017
    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 para la investigacion biomedica HUPA
    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 supportFundacion para la investigacion biomedica HUPA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Principe de Asturias
    B.5.2Functional name of contact pointVíctor Vaquerizo
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Alcalá – Meco s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number+349188781002454
    B.5.6E-mailvaquerizovictor@yahoo.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 nameplasma rich in growth factors
    D.3.2Product code PRGF
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Intraosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNplasma rich in growth factors
    D.3.9.2Current sponsor codePRGF
    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 number6 to 8
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntraosseous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Knee osteoarthritis.
    Artrosis de rodilla
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis.
    Artrosis de rodilla
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    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
    The main objective is to assess the effectiveness at 6 months, defined as improvement in the functionality and pain mesaured in the KOOS scale, of the intraarticular and intraosseus application of plasma rich in growth factors versus the intraarticular application of plasma rich in growth factors plus intraosseus administration of placebo.
    El objetivo general del estudio es evaluar la eficacia a los 6 meses, definida como mejoría en la funcionalidad y el dolor, medida mediante la escala KOOS, de la aplicación intraarticular más aplicación intraósea de plasma rico en factores de crecimiento frente a la aplicación intraarticular de plasma rico en factores de crecimiento más aplicación intraósea de placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness at 12 months measured in the KOOS scale
    To evaluate the effectiveness at 6 and 12 months measured in the WOMAC scale
    To assess radiological changes in the subchondral bone
    To asses the safety of the administration of plasma rich in growth factors
    Valorar la efectividad a los 12 meses del tratamiento con plasma rico en factores de crecimiento en la escala KOOS
    Valorar la efectividad a los 6 y 12 meses, medida mediante el test WOMAC.
    Valorar los cambios radiológicos del hueso subcondral a los 6 meses tras la aplicación intraósea.
    Valorar el perfil de seguridad de la aplicación de plasma rico en factores de crecimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 40 and 75.
    Both genders.
    Moderate to several pain and symptoms according to the KOOS scale of more than 6 months of evolution.
    Grade III- IV knee osteoathritis according to radiological criteria for the classification of Kellgren and Lawrence.
    Patients with no response to other pharmacological treatments.
    Able to fulfill the schedule of visits of the trial.
    BMI less than 35.
    Pacientes con edades comprendidas entre 40 y 75 años.
    Ambos sexos.
    Sintomatología moderada a severa según las escalas KOOS y WOMAC de más de 6 meses de evolución.
    Artrosis radiológica grados III y IV según la clasificación de Kellgren y Lawrence.
    Pacientes refractarios al tratamiento conservador.
    Capacidad para cumplir con las visitas del ensayo.
    Índice de masa corporal inferior a 35
    E.4Principal exclusion criteria
    Intraarticular infiltration with plasma rich in growth factors in the 12 months before the inclusion
    Intraarticular infiltration with hyaluronic acid in the 6 months before the inclusion.
    Angular alterations, higher than 15 degrees and unstable joint.
    Systemic or local infectious disease and polyarticular disease.
    Cancer under treatment or under follow-up.
    Immunosuppressive treatment or systemic autoimmune disease.
    Patient with hypertension or diabetes mellitus poorly controlled.
    Allergy to some study drugs or excipients.
    Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for infiltrations.
    Positive to sifilis, hepatitis B, hepatitis C or VIH+.
    Uncapable to understand or fulfill the questionnaries of the study.
    -Pacientes que hayan recibido infiltración con plasma rico en plaquetas en los últimos 12 meses.
    - Pacientes que hayan recibido previamente tratamiento mediante infiltraciones de ácido hialurónico en los últimos 6 meses.
    - Pacientes con alteraciones angulares severas, superior a 15 grados e inestabilidad articular.
    - Enfermedad infecciosa sistémica o local y enfermedad poliarticular.
    - Procesos tumorales en tratamiento o seguimiento médico.
    - Tratamientos inmunosupresores o procesos inmunodepresivos.
    - Pacientes con Hipertensión arterial o diabetes mellitus mal controlados.
    - Pacientes que presenten alergias a algunos de los fármacos del estudio o a alguno de sus componentes.
    - Pacientes en tratamiento con anticoagulantes o antiagregantes que no pueda revertirse temporalmente para las infiltraciones.
    - Tener una serología positiva para: Sífilis, Hepatitis B, Hepatitis C ó VIH I/II.
    - Incapacidad para entender los cuestionarios de salud y/o completarlos adecuadamente.
    - Pacientes sin capacidad de otorgar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Score at 6 months in the KOOS scale
    Puntuación a los 6 meses en la escala KOOS
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    Score at 12 months in the KOOS scale
    Score at 6 and 12 months in the WOMAC scale
    Puntuación a los 12 meses en la escala KOOS
    Puntuación obtenida a los 6 y 12 meses en la escala WOMAC
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    6 y 12 meses
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 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 visit of the last subject randomized
    Unefficacy of the treatment
    Safety issues
    Última visita del último paciente aleatorizado
    Ineficacia del tratamiento
    Por cuestiones de seguridad
    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 months21
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state86
    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)
    The expected normal treatment for this condition
    El tratamiento habitual para esta patología
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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