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    EudraCT Number:2012-004441-32
    Sponsor's Protocol Code Number:MSV-crio
    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:2012-11-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-004441-32
    A.3Full title of the trial
    Pilot clinical trial to determine the feasibility and safety of MSV * cryopreserved in the treatment of gonartrosis. * MSV = mesenchymal progenitor cells of expanded autologous bone marrow with GMP procedures of IBGM.
    Ensayo clínico piloto para determinar la viabilidad y seguridad de las MSV* criopreservadas en el tratamiento de gonartrosis. *MSV= Células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos GMP del IBGM.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to determine the feasibility and safety of MSV cryopreserved in the treatment of gonartrosis
    Ensayo clínico para determinar la viabilidad y seguridad de las MSV criopreservadas en el tratamiento de gonartrosis
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberMSV-crio
    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 SponsorFundación Teknon
    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 supportFundación Teknon
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Teknon
    B.5.2Functional name of contact pointRobert Soler Rich
    B.5.3 Address:
    B.5.3.1Street Addressc/Vilana, 12
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.4Telephone number+34-932906042
    B.5.5Fax number+34-932 906 041
    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 nameMSV/PA -células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos GM
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMSV
    D.3.9.2Current sponsor codeMSV
    D.3.9.4EV Substance CodeSUB27304
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number38000000 to 42000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence
    Pacientes diagnosticados de gonartrosis grados II, III y IV de Kellgren y Lawrence
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with knee osteoarthritis
    Pacientes diagnosticados con artritis de rodilla
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    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
    To evaluate the feasibility and safety of the MSV-cryo after cryopreservation process, restoration and recultivation, applied by percutaneous injection in the knee joint, as a treatment for osteoarthritis of the knee, which is realizable by checking each of the procedures in the protocol, including the cost of cell production, and recording any adverse effects related to cellular therapy and that may arise during the duration of the trial, whether or not related there to.
    Evaluar la viabilidad y la seguridad de las MSV-crio tras proceso de criopreservación, restauración y recultivo, aplicadas por inyección percutánea en la articulación de la rodilla, como tratamiento de la artrosis de rodilla, comprobando que es realizable cada uno de los procedimientos establecidos en el protocolo, incluyendo las incidencias de la producción celular, y registrando los posibles efectos adversos relacionados con la terapia celular y los que pudieran surgir durante la duración del ensayo clínico, ya sean o no relacionados con el mismo.
    E.2.2Secondary objectives of the trial
    To determine the clinical and variations denoting MR images degeneration or, conversely, progression of arthritic process, after 12 months after implantation effected in MSV-cryo the affected joint.
    Determinar los resultados clínicos y las variaciones de las imágenes RM que denoten degeneración o, por el contrario, progresión del proceso artrósico, después de 12 meses de haberse efectuado la implantación de MSV-crio en la articulación afecta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Gonarthrosis of 2nd, 3rd or 4th degrees of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
    2. Chronic painful knee mechanical characteristics.
    3. No local or systemic septic process
    4. Hematological and biochemical analysis without significant alterations that contraindicate treatment.
    5. Written informed consent of the patient.
    6. The patient is able to understand the nature of the study.
    1. Gonartrosis de 2º,3º o 4º grados de Kellgren y Lawrence (Kellgren & Lawrence, 1957) valorada por dos observadores.
    2. Rodilla dolorosa crónica de características mecánicas.
    3. Ausencia de proceso séptico local o sistémico
    4. Análisis hematológicos y bioquímicos sin alteraciones significativas que contraindiquen el tratamiento.
    5. Consentimiento Informado por escrito del paciente.
    6. El paciente es capaz de entender la naturaleza del estudio.
    E.4Principal exclusion criteria
    1. Patient <18 years, or legally dependent
    2. Patient> 70 years
    3. Previous intervention affected knee
    4. Intraarticular treatment in the last 6 months.
    5. Infection present (for inclusion in the study should not evidenced any signs infectious).
    6. Patients with positive serology for HIV 1 and 2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
    7. Congenital or developmental malformation translate and / or significant deformation of knee problems and condition of application and evaluation of results.
    8. Excess weight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). Being BMI = weight (kg): (height (m)) 2.
    9. Women who are pregnant or intend to become pregnant, or breastfeeding
    10. neoplastic disease
    11. United immunosuppressive
    12. Simultaneous participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
    13. Other conditions or circumstances that compromise study participation medically
    1. Paciente < 18 años, o legalmente dependiente
    2. Paciente > 70 años
    3. Intervención previa en rodilla afectada
    4. Tratamiento intraarticular en los últimos 6 meses.
    5. Infección presente (para incluirse en el estudio no debe evidenciarse ningún signo infeccioso).
    6. Pacientes que presenten serología positiva frente a HIV 1 y 2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) y Lúes.
    7. Enfermedades congénitas o evolutivas que traduzcan malformación y/o deformaciones significativas de la rodilla y condicionen dificultades de aplicación y de evaluación de los resultados.
    8. Sobrecarga ponderal expresada en índice de masa corporal (IMC) superior a 30,5 (obesidad grado II). Siendo IMC= masa (Kg): (altura (m))2.
    9. Mujeres embarazadas o que pretenden estarlo, o en periodo de lactancia
    10. Enfermedad neoplásica
    11. Estados inmunodepresivos
    12. Participación simultánea en otro ensayo clínico o tratamiento con otro producto en fase de Investigación en los 30 días previos a la inclusión en el estudio.
    13. Otras patologías o circunstancias que comprometan la participación en el estudio según criterio médico
    E.5 End points
    E.5.1Primary end point(s)
    The objective is to evaluate the feasibility and safety of the procedure and the medication by recording adverse events
    El objetivo es la evaluación de la viabilidad y seguridad del procedimiento y del medicamento mediante registro de efectos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Clinical improvement and cartilage quality assessed by algofuncionales rates, quality of life and image of the trial on schedule.
    Mejoría clínica del paciente y de la calidad del cartílago evaluadas mediante índices algofuncionales, de calidad de vida y de imagen según cronograma del ensayo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 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. 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
    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 months18
    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: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state3
    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)
    According normal clinical practice
    Acorde práctica clínica habitual
    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 Decision2013-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
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