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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005258-70
    Sponsor's Protocol Code Number:CSM/ON/2011
    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:2012-01-11
    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 number2011-005258-70
    A.3Full title of the trial
    Ensayo clínico fase I/II prospectivo, abierto, no aleatorizado de tratamiento de la osteonecrosis de la cabeza femoral mediante la administración de células mesenquimales autólogas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ensayo clínico de tratamiento de la osteonecrosis de la cabeza femoral mediante la administración de células mesenquimales autólogas.
    A.4.1Sponsor's protocol code numberCSM/ON/2011
    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 Universidad de Salamanca
    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 supportFundación Universidad de Salamanca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSalutis Research, SL
    B.5.2Functional name of contact pointConcepcion Moreno
    B.5.3 Address:
    B.5.3.1Street AddressC/ Eraso 21, Entreplanta D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491726 67 25
    B.5.5Fax number+3491361 29 77
    B.5.6E-mailconcepcion.moreno@salutis-research.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 nameCélulas mesenquimales
    D.3.2Product code CSM
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCélulas Mesenquimales Autólogas
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Pacientes con ostenecrosis de la cabeza femoral en estadios precoces, estadios inferiores a IIIC de la clasificación de ARCO.
    E.1.1.1Medical condition in easily understood language
    Pacientes con osteonecrosis de la cabeza femoral en estapas tempranas de la enfermedad.
    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
    Analizar la seguridad y factibilidad de la administración directa intrafemoral de células stem mesenquimales (CSM) autólogas expandidas in vitro en el tratamiento de pacientes con osteonecrosis femoral.
    E.2.2Secondary objectives of the trial
    Analizar la eficacia del procedimiento medida en términos Clínicos y Radiológicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Edad entre 18 y 70 años

    ? Diagnóstico clínico y por imagen (Rx y RMN) de osteonecrosis idiopática de la cabeza femoral

    ?Estadios < IIIA en la clasificación ARCO
    E.4Principal exclusion criteria
    ? Aquellos que a juicio del investigador no estén en una situación adecuada para tolerar el procedimiento

    ? Criterios clínicos y anestésicos que contraindiquen la cirugía (por ejemplo ASA IV-V)

    ? Enfermedad grave no controlada

    ? Mujeres embarazadas

    ? Pacientes con infección VIH+
    E.5 End points
    E.5.1Primary end point(s)
    Seguridad de procedimiento

    Factibilidad del tratamiento celular
    E.5.1.1Timepoint(s) of evaluation of this end point
    La seguridad será evaluada por la presencia de efectos adversos, tanto no graves como graves, relacionados con o sin la administración celular. Estos efectos adversos serán monitorizados en todo momento. Se realizará un seguimiento intensivo mediante ingreso hospitalario del enfermo en las horas previas y en los días posteriores a la administración celular.
    Los pacientes serán monitorizados intrahospitalariamente previo a la administración celular y en los días posteriores. También serán evaluados en la consulta al mes, 3 meses, 6 meses y 1 año tras la administración celular.

    La factibilidad del tratamiento será evaluada por los siguientes parámetros:Capacidad de obtención y expansión in vitro de una dosis celular y Administración local de las células en el foco necrótico
    E.5.2Secondary end point(s)
    Las variables secundarias son aquellas relacionadas con la eficacia del procedimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clínicos:

    o Evolución del dolor: mediante la evaluación seriada de la EVA

    o Evolución de la función articular, mediante la evaluación de la escala de Harris

    o Evolución de la calidad de vida mediante la evaluación del cuestionario SF-36.


    Radiológicos:

    Objetivación de la mejoría radiológica mediante resonancia magnética y radiología simple
    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 Yes
    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) Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    Desde la infusión de las CSM al paciente hasta el fin del seguimiento serán 12 meses.
    Periodo de reclutamiento: 24 meses desde la inclusión del primer paciente en el estudio.
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 10
    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 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 state10
    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)
    Expected normal treatment
    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 Decision2012-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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