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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2011-005441-13
    Sponsor's Protocol Code Number:C11-12
    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:2012-05-29
    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 number2011-005441-13
    A.3Full title of the trial
    Evaluation of efficacy and safety of autologous MSCs combined to biomaterials to enhance bone healing in patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics.
    “Evaluación de la eficacia y seguridad del injerto de un biomaterial combinado con CMM autólogas para mejorar la cicatrización ósea
    en pacientes con retraso en la consolidación de fractura de huesos largos, que requieren injerto de aposición o una alternativa ortobiológica”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of tissue engineering therapy to treat patients with delayed consolidation after fracture of long bones.
    Desarollo de terapia de ingenieria celular para tratar pacientes CON RETRASO EN LA CONSOLIDACION DE FRACTURAS DE HUESOS LARGOS
    A.3.2Name or abbreviated title of the trial where available
    REBORNE - ORthoCT1
    A.4.1Sponsor's protocol code numberC11-12
    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 SponsorINSERM
    B.1.3.4CountryFrance
    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 supportFP7
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz-Universidad Autónoma de Madrid
    B.5.2Functional name of contact pointEnrique Gómez Barrena
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261, HRT 1ª planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34914975473
    B.5.5Fax number34914269774
    B.5.6E-mailenrique.gomezbarrena@uam.es
    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 nameCultured Autologous Mesenchymal Stem Cells mixed with the biomaterial MBCP+ TM
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous Mesenchymal Stem Cells
    D.3.9.2Current sponsor codeMSCs
    D.3.10 Strength
    D.3.10.1Concentration unit cm2 square centimeter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000000
    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) Yes
    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
    Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture.
    Fractura Gustilo I y II abierta o cerrada de húmero, tibia o fémur diafiseal o metadiafisodiafiseal con estatus de no unión o unión retardada.
    E.1.1.1Medical condition in easily understood language
    Patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics.
    Pacientes con retraso en la consolidación de una fractura de huesos largos que necesita un injerto de aposición o una alternativa ortobiológica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10017081
    E.1.2Term Fracture delayed union
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of apposition of biomaterial with autologous MSCs at the fracture site
    Evaluar la seguridad de la aposición de un biomaterial con CMM antólogas en el sitio de la fractura.
    E.2.2Secondary objectives of the trial
    To obtain consolidation, without increasing the complication rate, of diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus)status delayed union (after 3 months), treated by standard care procedures plus apposition of biomaterial with autologous MSCs at the fracture site.
    Obtener consolidación clínica y radiológica de fracturas de diáfisis y/o metadiáfisis (femur, tibia, húmero) con estatus de retraso en la unión (más de 3 meses) tratados por procedimientos de cuidado estándar más aposición de un biomaterial con CMM autólogas en el sitio de la fractura.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 18 to 65 both sexes
    - traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture status delayed union or non union
    - at least 3 months from acute fracture
    - able to provide informed consent, and signed informed consent
    - patients (by themselves) should have medical health care coverage to be included in a research study
    - able to understand and accept the study constraints
    -Edad entre 18 y 65 años, ambos sexos
    -Fractura Gustilo I y II abierta o cerrada de húmero, tibia o fémur diafiseal o metadiafisodiafiseal con estatus de no unión o unión retardada.
    -Fractura con al menos tres meses desde la fase aguda.
    -Capaz de aprobar y firmar el consentimiento informado.
    -Para algunos países de la Unión Europea (Francia y España): Los pacientes deben tener cobertura médica (propia) para se incluidos.
    -Capaz de entender y aceptar las limitaciones del estudio
    E.4Principal exclusion criteria
    - pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
    - participation in another therapeutic trial previous 3 months
    - delayed union or non-union related to iatrogeny
    - segmental bone loss requiring therapy
    - vascular or neural injury
    - impossibility to meet appointments for the follow up
    - other fractures causing interference with weight bearing
    - infection
    viceral injuries of diseases interfering with callus formation
    - history of bone harvesting on iliac crest contraindicating bone-marriw aspiration
    - corticoid or immunosuppressive therapy more than one week in the 3 mionths prior ti study inclusion
    - history of prior concurrent diagnosis of HIV, Hepatitis B or C infection
    - insulin dependent diabetes
    - obesity
    - autoimmune inflammatory disease
    - current treatment by bisphonate or stopped in the 3 months prior to stydy inclusion
    - subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission a health facility.
    -Mujeres embarazadas, lactado y mujeres en edad fértil con un control inadecuado de la natalidad
    -Haber participado en otro estudio clínico en los tres mese previos.
    -Retrazo en la unión o no unión debida a procesos iatrogénicos
    -Pérdida ósea segmentaria que requiere un tratamiento específico (transporte óseo, aloinjerto estructural grande, megaprótesis, etc)
    -Lesiones vasculares o nerviosas
    -Otras facturas que interfieren con el soporte del peso
    -Infecciones (piel, tejido blando o hueso)
    -Lesiones viscerales y/o enfermedades que interfieran con la formación del callo (trauma craneoencefálico, etc.)
    -Historia clínica que contraindique la aspiración de médula ósea
    -Haber estado en tratamiento con corticoides o terapia inminosupresiva por más de una semana, en los tres meses previos a la inclusión en el estudio.

    -Estar embarazada o lactando el día de la inclusión en el estudio, o tener riesgo de embarazo durante el tratamiento
    -Historia clínica con diagnóstico previo o concomitante de VIH-, Hepatitis B- o infección por Hepatitis C- (confirmada por serología o PCR)
    -Sujetos bajo protección legal
    -Imposibilidad de acudir a las citas de seguimiento
    -Pacientes diabéticos insulinodependientes
    -Enfermedad inflamatoria autoinmune
    -Estar en tratamiento actual con bifosfonato o haber terminado el tratamiento en los tres meses previos a la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - local complication rate regarding the non-union treatment in the FU
    - local and general complication rate regarding potential effects of introducing the biomaterial with with MSC in the FU of patients.
    - complicaciones locales relacionadas con el tratamiento de la no-unión en el seguimiento
    - complicaciones locales y generales relacionadas con infecciones, u otros efectos de las CMM, en seguimiento de los pacientes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    complication rates at weeks : 6, 12, 24
    tasa de compliaciones a la semana: 6,12,24
    E.5.2Secondary end point(s)
    - number of patients with proven bone healing, in proportion of the recruited , treated patients.
    - clinical consolidation
    - no reoperation done or scheduled
    - changes in serum levels of bone turnover markers
    Número de pacientes con cicatrización ósea a las 6 semanas, 12 semanas y 24 semanas (definido como 3 de 4 o 2 de 3 cortezas, con confirmación del puente óseo por imagen), como proporción de los pacientes reclutados y tratados.
    -Presencia de callo radiológico a las 6 semanas, 12 semanas y 24 semanas.
    -Consolidación clínica a las 6, 12, 24 semanas.
    -No prever o hacer una reoperación las 24 semanas.
    -Cambio en los niveles séricos de marcadores de recambio óseos
    E.5.2.1Timepoint(s) of evaluation of this end point
    - number of patients with proven bone healing at 6 weeks, 12 weeks, and 247 weeks
    - clinical consolidation at weeks 6, 12, 24
    - no reoperation done or scheduled at 24 weeks
    -Número de pacientes con probada consolidación a las 6 semanas, 12 semanas y 247 semanas.
    - consolidación clínica a las semanas 6,12,y 21
    -no reoperación o programación de reoperación a las 24 semanas
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 30
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Non applicable
    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 Decision2013-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-15
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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