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    Summary
    EudraCT Number:2017-002129-39
    Sponsor's Protocol Code Number:XC.ROD.2017
    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:2017-08-10
    Trial results View 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 number2017-002129-39
    A.3Full title of the trial
    Phase II Clinical Trial to Know the effectiviness and safety with a a treatment based in a therapy with serical autologous white cells versus the use of Platelet Rich Plasma in patients with rotulian tendinopathy.
    ENSAYO CLÍNICO EN FASE II PARA CONOCER LA EFICACIA Y SEGURIDAD DEL USO DE CÉLULAS DE LA SERIE BLANCA FRENTE AL USO DE PRP EN PACIENTES CON TENDINOPATÍA ROTULIANA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparision of two treatments, MR2 versus GPS III®in patients with rotulian tendinopathy
    Comparación de dos tratamientos, el M2R y el KIT GPS III® en pacientes con tendinopatía rotuliana
    A.4.1Sponsor's protocol code numberXC.ROD.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 SponsorXCELL Medical Solutions
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportXCELL Medical Solutions SL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXCELL Medical Solutions SL
    B.5.2Functional name of contact pointPablo García de la Riva
    B.5.3 Address:
    B.5.3.1Street AddressFortuny, 29 1ª
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28010
    B.5.3.4CountrySpain
    B.5.4Telephone number34620340632
    B.5.6E-mailpgdelariva@m2rlab.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 nameM2R. Terapia sérica autóloga con células de la serie blanca
    D.3.4Pharmaceutical form Blood fraction modifier
    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 INNM2R. Terapia Sérica autóloga con células de la serie blanca
    D.3.9.3Other descriptive nameHUMAN PLASMA FOR FRACTIONATION
    D.3.9.4EV Substance CodeSUB12043MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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. Plasma Rico en Plaquetas
    D.3.4Pharmaceutical form Blood fraction modifier
    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 INNPRP. Plasma Rico en Plaquetas
    D.3.9.3Other descriptive nameHUMAN PLASMA FOR FRACTIONATION
    D.3.9.4EV Substance CodeSUB12043MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number9
    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
    Patients with Rotulian Tendinopathy
    Pacientes con tendinopatía Rotuliana
    E.1.1.1Medical condition in easily understood language
    Patients with Rotulian Tendinopathy
    Pacientes con tendinopatía Rotuliana
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10043237
    E.1.2Term Tendon, ligament and cartilage disorders
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate and compare the effectiveness in pain reduction and safety in a treatment based in a therapy with serical autologous white cells versus the use of Platelet Rich Plasma with the commercial Kit of GPS® III from Biomet Biologics.
    Evaluar y comparar la eficacia en la reducción del dolor y la seguridad del tratamiento basado en una terapia sérica autóloga con células de la serie blanca frente al uso de PRP con el kit comercial GPS® III de Biomet Biologics.
    E.2.2Secondary objectives of the trial
    Evaluate and compare the efficacy in the recovery of mobility in a treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics.

    -Evaluate and compare the efficacy in the state of the injury in a treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics.

    -Evaluate the patients satisfaction with treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics.
    - Evaluar y comparar la eficacia en la recuperación de la movilidad del tratamiento basado en una terapia sérica autóloga con células de la serie blanca (M2R-XCell) frente al uso de PRP con el kit comercial GPS® III de Biomet Biologics.

    - Evaluar y comparar la eficacia en el estado de la lesión del tratamiento basado en una terapia sérica autóloga con células de la serie blanca (M2R-XCell) frente al uso de PRP con el kit comercial GPS® III de Biomet Biologics.
    - Evaluar la satisfacción del paciente con el tratamiento basado en una terapia sérica autóloga con células de la serie blanca (M2R-XCell) frente al uso de PRP con el kit comercial GPS® III de Biomet Biologics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient that have willingly signed and have to be able to sign the informed
    consent for the participation in the trial. 2. Patients aged between 18 and 70 years, in case of woman of fertile age, the use of a contraceptive method.
    3. Outpatient before the injury, without help for walk or need to assistance of other
    person. 4. Patients Diagnosed with unilateral lesion at the inferior pole of the patella,
    with echographic images of anteroposterior thickening, focal area of hypoechoic
    changes and discontinuity of tendon fibers. 5. Persistence of the symptoms after at
    least 3 months of conservative treatment. 6. Patients for whom non-surgical
    treatment has been decided. 7. Patient be able (in investigator´s opinion) to meet all
    the study requirements. 8. Patients that practice sports usually, whether they are
    elite athletes or amateurs. 9. Patients willing to attend the site for scheduled visits in
    the 24-week of follow-up.
    1. El paciente está dispuesto y es capaz de dar su consentimiento informado para la participación en el estudio
    2. Pacientes de edad entre 18 y 70 años, en el caso de mujeres en edad fértil, será preciso el uso de un método anticonceptivo.
    3. Pacientes ambulatorios antes de la lesión, sin el uso de ayudas para caminar ni necesidad de asistencia de otra persona
    4. Diagnosticados de lesión unilateral en la inserción del polo inferior de la rótula, con imágenes ecográficas de engrosamiento anteroposterior, área focal de cambios hipoecoicos y discontinuidad de las fibras tendinosas.
    5. Persistencia de síntomas tras, al menos, 3 meses de tratamiento conservador.
    6. Pacientes en los que se ha decidido tratamiento no quirúrgico
    7. Paciente capaz (en opinión del investigador) y dispuestos a cumplir con todos los requisitos del estudio
    8. Paciente que practica deporte habitualmente, ya sean deportistas de élite o amateurs
    9. Dispuesto a asistir al centro para las visitas programadas en las 24 semanas de seguimiento
    E.4Principal exclusion criteria
    1. Patients with lesions in both rotulian tendons
    2. Severe pre-injury of tendon or ankle or deformity in any of the lower limbs.
    3. Previous infiltration or previous
    surgery on the knee.
    4. Medical History of diabetes mellitus.
    5. Patients with known plasma abnormalities or haematological disorder:
    A. Platelet abnormality (<150,000
    plat / mm3).
    B. Hematologic abnormality.
    C. Hemoglobin in blood <11g / dL or
    hematocrit <34%
    6. Current use of systemic cortisone or treatment with anticoagulants (ie, a prophylactic dose for the prevention of thrombosis would not
    be an exclusion criteria)
    7. Evidence of gangrene of the lower extremities / ulcers or
    peripheral vascular disorder.
    8. History of liver failure or renal failure or dialysis
    9. Female patients who are pregnant or with the intention of becoming pregnant
    10. Patients that currently are receiving radiotherapy or chemotherapy or has received it
    in the last 3 months.
    11. Patients with an inadequate venous access for blood
    collection.
    12. Any other significant disease or disorder that, in the opinion of the investigator, could put participants at risk due to participation in the study, or may influence in the results of the study, or the ability of patients to participate in the study .
    1. Pacientes con lesiones en ambos tendones rotulianos
    2. Lesiones previas graves en tendón o en el tobillo o deformidad en cualquiera de sus extremidades inferiores.
    3. Infiltración previa o cirugía previa en la rodilla
    4. Antecedentes de diabetes mellitus
    5. Pacientes con anormalidades plasmáticas conocidas o trastorno hematológico:
    a. Anormalidad plaquetaria (<150.000 plaq/mm3).
    b. Anormalidad hematológica.
    c. Hemoglobina en sangre<11g/dL o hematocrito<34%
    6. Uso actual de cortisona sistémica o tratamiento con anticoagulante (es decir, una dosis profiláctica para la prevención de trombosis no sería una exclusión)
    7. Evidencia de gangrena de las extremidades inferiores / úlceras o enfermedad vascular periférica
    8. Historia de insuficiencia hepática o insuficiencia renal o diálisis
    9. Las pacientes mujeres que están embarazadas con intención de quedar embarazadas
    10. Actualmente recibe radioterapia o quimioterapia o lo ha hecho en los últimos 3 meses
    11. Tiene acceso venoso inadecuado para la extracción de sangre.
    12. Cualquier otra enfermedad o trastorno significativo que, en opinión del investigador, podrían poner a los participantes en riesgo debido a la participación en el estudio, o pueden influir en el resultado del estudio, o la capacidad de los pacientes para participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of the pain and severity of the injury: -Victorian Institute of Sports
    Assessment: Rotulian Tendinophaty (VISA-P) -Visual analogue Scale for pain
    (VAS)
    Evolución del dolor y del grado de severidad de la lesión:
    - Índice de severidad de la tendinopatía rotuliana (VISA-P)
    - Escala subjetiva del dolor (VAS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, 12 y 24
    Semanas 2, 4, 8, 12 y 24
    E.5.2Secondary end point(s)
    Evolution of the injury of the tendon at functional and histological level
    Evolución de la lesión del tendón a nivel funcional e histológico .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, 12 y 24
    Semanas 2, 4, 8, 12 y 24
    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 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) 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 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
    Última Vista del último sujeto reclutado
    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 months6
    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: 40
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    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 Decision2017-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-22
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