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    Summary
    EudraCT Number:2013-000930-37
    Sponsor's Protocol Code Number:STEMQUIRI/12ES01
    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:2013-06-10
    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 number2013-000930-37
    A.3Full title of the trial
    A phase II clinical trial to assess the effect of HC-SVT-1001 (autologous fat stem adult mesenchymal cells expanded and combined with a tricalcium phosphate biomaterial) and HC-SVT-1002 (allogeneic fat stem adult mesenchymal cells expanded and combined with a tricalcium phosphate biomaterial) in the surgical treatment of atrophic pseudarthrosis of long bones
    Ensayo clínico fase II para evaluar el efecto del HC-SVT-1001 (células mesenquimales troncales adultas autólogas de tejido adiposo expandidas e incluidas en biomaterial de fosfato tricálcico)y del HC-SVT-1002 (células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas e incluidas en biomaterial de fosfato tricálcico)en el tratamiento quirúrgico de pseudoartrosis atróficas de huesos largos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II clinical trial to assess the effect of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of nonunions fractures of long bones
    Ensayo clínico fase II para evaluar el efecto del HC-SVT-1001 y del HC-SVT-1002 en el tratamiento quirúrgico de fracturas no consolidadas de huesos largos
    A.4.1Sponsor's protocol code numberSTEMQUIRI/12ES01
    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 SponsorLaboratorios Salvat, S.A.
    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 supportLaboratorios Salvat, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Salvat, S.A.
    B.5.2Functional name of contact pointDepartamento Médico
    B.5.3 Address:
    B.5.3.1Street AddressGall, 30-36
    B.5.3.2Town/ cityEsplugues de Llobregat
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number34933946469
    B.5.5Fax number34934738724
    B.5.6E-mailclinicaltrials@svt.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 nameHC-SVT-1001
    D.3.2Product code HC-SVT-1001
    D.3.4Pharmaceutical form Implant in pre-filled syringe
    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 INNNot assigned
    D.3.9.2Current sponsor codeHC-SVT-1001
    D.3.9.3Other descriptive nameEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    D.3.9.4EV Substance CodeSUB30305
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 45
    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.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 Yes
    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 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 nameHC-SVT-1002
    D.3.2Product code HC-SVT-1002
    D.3.4Pharmaceutical form Implant in pre-filled syringe
    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 INNNot assigned
    D.3.9.2Current sponsor codeHC-SVT-1001
    D.3.9.3Other descriptive nameEXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    D.3.9.4EV Substance CodeSUB30305
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 45
    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.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 Yes
    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
    Atrophic pseudarthrosis
    Pseudoartrosis atrófica
    E.1.1.1Medical condition in easily understood language
    Nonunion fracture
    Fractura ósea no consolidada
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10048617
    E.1.2Term Pseudarthrosis
    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 evaluate the safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.

    - To evaluate the effectiveness by appearance of signs of osseous setting formation at least in 2 out of 3 cortical (tibia) or 3 out of 4 cortical (humerus, femur, cubitus, radius) within 6 months after surgery.
    - Evaluar la seguridad de la utilización de HC-SVT-1001 y de HC-SVT-1002, en el tratamiento quirúrgico de pseudoartrosis atróticas de huesos largos, mediante la cuantificación de acontecimientos adversos registrados a lo largo del estudio.

    - Evaluar la eficacia mediante criterios radiográficos determinada por la consolidación de 2 de 3 corticales (tibia) ó 3 de 4 corticales (húmero, cúbito, radio o fémur) en el plazo de 6 meses después de la cirugía.
    E.2.2Secondary objectives of the trial
    Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements.
    Realizar un análisis estadístico comparativo que relacione aspectos fundamentales como incidencia de efectos adversos, complicaciones, tiempos de curación, etc. entre los 12 pacientes del presente estudio y los datos de 14 casos consecutivos de pseudoartrosis refractaria de huesos largos que han sido tratados desde fecha 1-9-2009 con dosis celulares de 40x106 MSC de médula ósea autóloga, expandidas con procedimientos GMP del IBGM de Valladolid y correspondientes a tratamientos de usos compasivos autorizados y sometidos al control de la AEMPS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients of either sex between 18 and 65 years of age (both inclusive)
    2.Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically
    3.Hematological and biochemical results without significant alterations where a surgery is contraindicated
    4.Signed informed consent from the patient
    5.The patient is able to understand the nature of the study.
    1. Pacientes entre 18 y 65 años, ambos sexos.
    2. Diagnóstico de pseudoartrosis no hipertrófica de hueso largo confirmada radiográficamente
    3. Análisis hematológicos y bioquímicos sin alteraciones significativas que contraindiquen la intervención
    4. Consentimiento Informado por escrito del paciente.
    5. El paciente es capaz de entender la naturaleza del estudio.
    E.4Principal exclusion criteria
    1.Participation in another clinical trial within the 3 months prior to inclusion.
    2.Present infection (infection signs that may impact on the evolution of the lesion should not be evidenced)
    3.Other lesions which interfere with the body weight load.
    4.Known or suspected allergy to Penicillin, Streptomycin, bovine serum and pig products .
    5.Open pseudoarthrosis (at the time of inclusion)
    6. Pregnant or lactating women
    7.Women of childbearing potential not using effective contraception (eg intrauterine device, oral contraceptives, barrier methods of birth control or other deemed appropriate by the investigator)
    8. Neoplastic disease
    9. Immunosuppressive state
    10. Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
    11. Chronic renal disease.
    12.Smoker of more than 15 cigarettes a day.
    13. Badly managed diabetes mellitus.
    14. Previous therapeutic radiation (5 previous years) of the affected bone.
    15. Peripheral arterial disorders.
    16. Other conditions or circumstances that compromise the study participation according to medical criteria
    1. Participación en otro ensayo clínico en los 3 meses previos a su inclusión.
    2. Infección presente (no debe evidenciarse ningún signo infeccioso con repercusión sobre la evolución de la lesión tratada).
    3. Otras lesiones que interfieran con la carga de peso corporal.
    4. Alergias conocidas o sospecha a Penicilina, Estreptomicina, sueros bovinos y productos porcinos.
    5. Pseudoartrosis abierta (en el momento de la inclusión)
    6. Mujeres embarazadas o en periodo de lactancia
    7. Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces (p.ej. dispositivo intrauterino, anticonceptivos orales, métodos de barrera u otro anticonceptivo considerado adecuado por el investigador)
    8. Enfermedad neoplásica
    9.Estados immunodepresivos
    10. Enfermedades congénitas óseas (Hipofosfatemia), enfermedad metabólica ósea asociada con hipoparatiroidismo primario o secundario.
    11. Patología renal crónica
    12.Fumador de más de 15 cigarrillos/ día.
    13.Diabetes mellitus mal controlada.
    14.Radiación terapéutica en el hueso afectado en los últimos 5 años.
    15.Trastorno vascular periférico.
    16.Otras patologías o circunstancias que comprometan la participación en el estudio según criterio médico.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation within 6 months after surgery.
    El objetivo es la evaluación de la eficacia mediante criterios radiográficos determinada por la aparición de indicios de formación de callo óseo en el plazo de 6 meses después de la cirugía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiographic series performed in pre-surgery and surgery visit and follow-up visits (1 month after surgery and at 3, 4 and 6 months)
    Series radiográficas realizadas en pre-cirugía, cirugía y en las visitas de seguimiento (1 mes post-cirugía y a los 3, 4 y 6 meses)
    E.5.2Secondary end point(s)
    Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements.
    Realizar un análisis estadístico comparativo que relacione aspectos fundamentales como incidencia de efectos adversos, complicaciones, tiempos de curación, etc. entre los 12 pacientes del presente estudio y los datos de 14 casos consecutivos de pseudoartrosis refractaria de huesos largos que han sido tratados desde fecha 1-9-2009 con dosis celulares de 40x106 MSC de médula ósea autóloga, expandidas con procedimientos GMP del IBGM de Valladolid y correspondientes a tratamientos de usos compasivos autorizados y sometidos al control de la AEMPS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Al final del estudio
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    LVLP
    LVLP
    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
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state12
    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)
    As per usual medical practice
    De acuerdo con la práctica médica 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 Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-20
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