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    Summary
    EudraCT Number:2020-003179-16
    Sponsor's Protocol Code Number:DA-SARC
    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:2024-10-23
    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 number2020-003179-16
    A.3Full title of the trial
    Randomized Clinical Trial Comparing Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis
    Ensayo clínico aleatorizado para el tratamiento de la epicondilitis lateral con Desbridamiento Artroscópico Versus Suero Autólogo Rico en Citoquinas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing surgical intervention versus infiltration of cytokine autologous rich serum (proteins derived from the patient's own blood) for the treatment of tennis elbow.
    Comparación de la intervención quirúrgica con la infiltración de suero autólogo rico en citoquinas (proteínas derivadas de la propia sangre del paciente) para el tratamiento del codo de tenista
    A.4.1Sponsor's protocol code numberDA-SARC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04194710
    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 SponsorFUNDACIÓ PARC TAULÍ
    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 supportTecnologia Regenerativa QREM S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ PARC TAULÍ
    B.5.2Functional name of contact pointFerran Fillat
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí 1, Edifici Santa Fe 2ª planta, ala Esquerra
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number+34937231010
    B.5.6E-mailffillat@tauli.cat
    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 nameCytokine Rich Serum
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCytokine Rich Serum
    D.3.9.3Other descriptive nameAutologous platelet rich plasma and blood cells, peripheral blood-derived
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 5
    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 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
    Lateral Epicondylitis
    Epicondilitis lateral
    E.1.1.1Medical condition in easily understood language
    Tennis Elbow
    Codo de tenista
    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
    The main objective is to evaluate the efficacy of Cytokine Rich Serum (CRS) obtained by QREM CYTOKINE compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.
    El objetivo principal es evaluar la eficacia del Suero Rico en Citoquinas (SRC) obtenido mediante QREM CYTOKINE en comparación con la resección artroscópica en la reducción del dolor a medio plazo (6 meses) en pacientes con epicondilitis crónica lateral.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - evaluate the efficacy of CRS compared with arthroscopic resection in reducing pain in the short (15 days, 1 month, 3 months) and long term (12 and 24 months) in patients with chronic lateral epicondylitis.
    - evaluate other efficacy parameters (functional improvement, pain at wrist extension and grip strength) in the short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term.
    - assess the safety (incidence of adverse events) of CRS in the short (15 days, 1 month, 3 months), medium (6 months) and long (12 and 24 months) term.
    Los objetivos secundarios son:
    - evaluar la eficacia de SRC en comparación con la resección artroscópica en la reducción del dolor a corto (15 días, 1 mes, 3 meses) y largo plazo (12 y 24 meses) en pacientes con epicondilitis crónica lateral.
    - evaluar otros parámetros de eficacia (mejora funcional, dolor a la extensión de la muñeca y fuerza de agarre) a corto (15 días, 1 mes, 3 meses), medio (6 meses) y largo (12 y 24 meses) plazo.
    - evaluar la seguridad (incidencia de acontecimientos adversos) del SRC a corto (15 días, 1 mes, 3 meses), medio (6 meses) y largo (12 y 24 meses) plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Over 18 years of age
    Patients with persistent pain (EVA > 5) at lateral epicondyle level of at least 3 months duration.
    Patients with a diagnosis of chronic lateral epicondylitis confirmed with a complementary diagnostic test such as Echo or MRI.
    Availability to follow the study protocol for up to 24 months.
    Patients with the ability to understand study information and give informed consent.
    Patients who sign informed consent.
    Normal hematologic parameters.
    Mayores de 18 años
    Pacientes con dolor persistente (EVA> 5) a nivel de epicóndilo lateral de al menos 3 meses de duración.
    Pacientes con diagnóstico de epicondilitis lateral crónica confirmada con una prueba diagnóstica complementaria como Eco o MRI.
    Disponibilidad para seguir el protocolo del estudio hasta por 24 meses.
    Pacientes con la capacidad de comprender la información del estudio y dar su consentimiento informado.
    Pacientes que firman consentimiento informado.
    Parámetros hematológicos normales.
    E.4Principal exclusion criteria
    Local infection present.
    Patients who have been treated with corticosteroid infiltrations in the same area in the past 4 months.
    Patients who have received treatment with growth factors, PRP, cytokines, or new drug treatments in the same area in the last 12 months.
    Pregnancy or breast-feeding.
    Neoplastic disease.
    Patients being treated with immunosuppressants (medical evaluation).
    Patients undergoing arthroscopic surgery of the same elbow.
    Active liver disease.
    Immunosuppressive or immunodeficiency states.
    Coagulation deficit or abnormalities.
    Thrombocytopenia.
    Treatment with anticoagulants.
    Difficulty understanding and following study procedures.
    Participation in a clinical trial with medications.
    Infección local presente.
    Pacientes que han sido tratados con infiltraciones de corticosteroides en la misma área en los últimos 4 meses.
    Pacientes que han recibido tratamiento con factores de crecimiento, PRP, citocinas o nuevos tratamientos farmacológicos en la misma área en los últimos 12 meses.
    Embarazo o lactancia.
    Enfermedad neoplásica.
    Pacientes en tratamiento con inmunosupresores (evaluación médica).
    Pacientes sometidos a cirugía artroscópica del mismo codo.
    Enfermedad hepática activa.
    Estados inmunosupresores o de inmunodeficiencia.
    Déficit de coagulación o anormalidades.
    Trombocitopenia
    Tratamiento con anticoagulantes.
    Dificultad para comprender y seguir los procedimientos de estudio.
    Participación en un ensayo clínico con medicamentos.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of pain to 6 months measured with the EVA scale. The specification of the efficacy parameter is an absolute improvement of the 2-point scale.
    Reducción del dolor a 6 meses medido con la escala EVA. La especificación del parámetro de eficacia es una mejora absoluta de la escala de 2 puntos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after intervention
    6 meses después de la intervención
    E.5.2Secondary end point(s)
    Pain assessment: EVA scale
    Patient-Related Tennis Elbow Evaluation (PRTEE) Functional outcome
    Grip force measured with a palm grip dynamometer, in kilos
    Occurrence of pain with resisted wrist extension assessed during medical examination
    Complications assessment assessed during medical examination
    Revision of anti-inflammatory medication and its dose assessed during medical examination
    Evaluación del dolor: escala EVA
    Evaluación funcional del codo de tenista relacionada con el paciente (PRTEE) Resultado funcional
    Fuerza de agarre medida con un dinamómetro de agarre de palma, en kilos
    Ocurrencia de dolor con extensión de muñeca resistida evaluada durante el examen médico
    Evaluación de complicaciones evaluada durante el examen médico
    Revisión de medicamentos antiinflamatorios y su dosis evaluada durante el examen médico
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 days, 1-3-6-12-24 months after intervention
    15 días, 1-3-6-12-24 meses después de la intervención
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Resección artroscópica (intervención quirúrgica)
    Arthroscopic resection (surgical intervention)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years3
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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)
    None
    Ninguno
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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