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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2021-001267-24
    Sponsor's Protocol Code Number:UCA-12-EC/21/ALO
    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:2022-01-24
    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 number2021-001267-24
    A.3Full title of the trial
    Pilot study to evaluate intra-articular infiltrations of allogeneic Platelet Rich Plasma (PRP) for the treatment of knee osteoarthritis.
    Estudio piloto para evaluar las infiltraciones intraarticulares de Plasma Rico en Plaquetas (PRP) alogénico para el tratamiento de la artrosis de rodilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study to evaluate intra-articular infiltrations of Platelet Rich Plasma (PRP) from donor blood for the treatment of osteoarthritis of the knee.
    Estudio piloto para evaluar las infiltraciones intraarticulares de Plasma Rico en Plaquetas (PRP) procedente de sangre de donante para el tratamiento de la artrosis de rodilla.
    A.4.1Sponsor's protocol code numberUCA-12-EC/21/ALO
    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 SponsorArthroscopic Surgery Unit
    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 supportArthroscopic Surgery Unit
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArthroscopic Surgery Unit
    B.5.2Functional name of contact pointResearch Department
    B.5.3 Address:
    B.5.3.1Street AddressC/Beato Tomás de Zumárraga 10
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01008
    B.5.3.4CountrySpain
    B.5.4Telephone number34945252077411
    B.5.6E-maildiego.delgado@ucatrauma.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 Yes
    D.2.1.1.1Trade name PRGF-Endoret
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePlatelet Rich Plasma (PRGF-Endoret)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    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
    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 Diseases [C] - Musculoskeletal Diseases [C05]
    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 efficacy of intra-articular infiltrations of allogeneic PRP in patients with osteoarthritis of the knee.
    Evaluar la seguridad y eficacia las infiltraciones intraarticulares de PRP alogénico en pacientes con artrosis de rodilla.
    E.2.2Secondary objectives of the trial
    To compare the composition and cellular response in in vitro cultures of PRP obtained from patients with allogeneic PRP obtained from donors.
    Comporar la composición y la respuesta celular en cultivos in vitro del PRP obtenido de los pacientes con el PRP alogénico obtenido de los donantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of both sexes aged between 60 and 85 years.
    Diagnosed with osteoarthritis by means of a clinical radiological study.
    Joint pain equal to or greater than 2.5 points on VAS.
    Ahlbäck radiological degree of severity, 1 or 2.
    Body Mass Index values between 20 and 35.
    Possibility for observation during the follow-up period.
    Pacientes de ambos sexos con edades comprendidas entre los 60 y los 85 años.
    Diagnosticados de artrosis mediante estudio clínico radiológico.
    Dolor en la articulación igual o superior a 2,5 puntos en EVA.
    Grado de severidad radiológica Ahlbäck, 1 o 2.
    Valores de Índice de Masa Corporal entre 20 y 35.
    Posibilidad para observación durante el periodo de seguimiento.
    E.4Principal exclusion criteria
    Bilateral gonarthrosis requiring infiltration of both knees
    Body mass index >35
    Severe mechanical deformity (varus 4º and valgus 16º bidiaphyseal).
    Previous arthroscopy within the last year.
    Intra-articular hyaluronic acid or corticosteroid infiltration within the last 6 months.
    Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotising vasculitis).
    Poorly controlled diabetes mellitus (glycosylated haemoglobin greater than 9%).
    Pregnancy or lactation.
    Gonartrosis bilateral que requiera infiltración en ambas rodillas
    Índice de masa corporal>35
    Deformidad mecánica severa (varo 4º y valgo 16º bidiafisarios)
    Artroscopia previa en el último año.
    Infiltración intraarticular de ácido hialurónico o corticoides en los 6 últimos meses.
    Enfermedad reumática autoinmune sistémica (enfermedades del tejido conectivo y vasculitis necrotizantes sistémicas).
    Diabetes Mellitus mal controlada (hemoglobina glicosilada superior al 9%)
    Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Clinically significant pain improvement according to KOOS scale (Knee injury and Osteoarthritis Outcome Score)
    Mejoría dolor clínicamente significativa KOOS (Knee injury and Osteoarthritis Outcome Score)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 2, Month 6 and Month 12
    Mes 2, Mes 6 y Mes 12
    E.5.2Secondary end point(s)
    Symptom improvement clinically significant (KOOS).
    Improved performance of daily activities clinically significant (KOOS).
    Improved performance of sport activities clinically significant (KOOS).
    Improved quality of life clinically significant (KOOS).
    Mejoría de los síntomas clínicamente significativa (KOOS).
    Mejoría desempeño de las actividades cotidianas clínicamente significativa (KOOS).
    Mejoría desempeño de las actividades deportivas y recretativas clínicamente significativa (KOOS).
    Mejoría de la calidad de vida clínicamente significativa (KOOS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 2, Month 6 and Month 12
    Mes 2, Mes 6 y Mes 12
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state15
    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
    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 Decision2022-06-24
    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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