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    Summary
    EudraCT Number:2013-005025-23
    Sponsor's Protocol Code Number:XCEL-PSART-01
    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:2014-01-09
    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 number2013-005025-23
    A.3Full title of the trial
    A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrphic pseudoarthrosis of long bones
    Estudio clínico piloto de fase IIa, unicéntrico, prospectivo, aleatorizado, paralelo, de dos brazos de tratamiento, abierto con evaluación ciega y de dosis única para la evaluación de células mesenquimales troncales adultas autólogas expandidas ?ex vivo? conjugadas en matriz ósea de origen alogénico (XCEL-MT-OSTEO-ALPHA) en el tratamiento de la pseudoartrosis no hipertrófica de huesos largos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrphic pseudoarthrosis of long bones
    Estudio clínico piloto de fase IIa, unicéntrico, prospectivo, aleatorizado, paralelo, de dos brazos de tratamiento, abierto con evaluación ciega y de dosis única para la evaluación de células mesenquimales troncales adultas autólogas expandidas ?ex vivo? conjugadas en matriz ósea de origen alogénico (XCEL-MT-OSTEO-ALPHA) en el tratamiento de la pseudoartrosis no hipertrófica de huesos largos
    A.4.1Sponsor's protocol code numberXCEL-PSART-01
    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 SponsorBanc de Sang i Teixits (BST)
    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 supportBanc de Sang i Teixits
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanc de Sang i Teixits (BST)
    B.5.2Functional name of contact pointRuth Coll Bonet, Directora Médica
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Taulat, 116
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08005
    B.5.3.4CountrySpain
    B.5.4Telephone number+349355735006707
    B.5.5Fax number+34935573502
    B.5.6E-mailrucoll@bst.cat
    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 nameXCEL-MT-OSTEO-ALPHA
    D.3.2Product code XCEL-MT-OSTEO-ALPHA
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeXCEL-M-ALPHA
    D.3.9.3Other descriptive nameEX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB27304
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3000000 to 5000000
    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 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
    pseudarthrosis
    pseudoartrosis
    E.1.1.1Medical condition in easily understood language
    Non-healing fractures
    Fracturas no curadas
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 assess the efficacy of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones through quantifying of the Hounsfield units by TC at month 12 postreatment.
    - Evaluar la eficacia de la implantación de XCEL-MT-OSTEO-ALPHA en el tratamiento de la pseudoartrosis no hipertrófica de huesos largos mediante la evaluación de la consolidación por la determinación de Hounsfield units en estudio TC practicado al paciente a los 12 meses post tratamiento
    E.2.2Secondary objectives of the trial
    -To assess the feasibility and safety of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones
    -To assess the efficacy of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones through:
    a)Characteristics of the callus by TC at month 6 postreatment
    b)Characteristics of the callus by standard x-ray
    c)Quality of life by EUROQOL-5D test
    - Evaluar la viabilidad y la seguridad de la implantación de XCEL-MT-OSTEO-ALPHA en el tratamiento de pseudoartrosis no hipertrófica de huesos largos.
    - Evaluar la eficacia de la implantación de XCEL-MT-OSTEO-ALPHA en el tratamiento de la pseudoartrosis no hipertrófica de huesos largos mediante:
    a) Evaluación de las características del callo óseo mediante TC a los 6 meses post tratamiento
    b) Evaluación de las características del callo óseo mediante radiología estándar
    c) Evaluación de la de la calidad de vida mediante el test EUROQOL-5D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 85 years of age (male and female)
    2. Atrophic or hypothrophic metaphyseal?diaphyseal pseudarthrosis of long bones, confirmed radiographically.
    3. Informed Consent Form signed
    4. The patient is able to understand the nature of the study
    1. Pacientes de 18 a 65 años de edad.
    2. Pseudoartrosis atrófica o hipotrófica metafisodiafisaria adquirida de huesos largos confirmada radiográficamente.
    3. Consentimiento Informado por escrito del paciente.
    4. El paciente es capaz de entender la naturaleza del estudio.
    E.4Principal exclusion criteria
    1. Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
    2. Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
    3. Significant abnormal laboratory tests that contraindicates patient?s participation in the study.
    4. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
    5. Smoker of more than 15 cigarettes a day
    6. Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
    7. Badly managed diabetes mellitus.
    8. Patients diagnosed with peripheral arterial disorders
    9. Previous therapeutic radiation (5 previus years) of the affected bone.
    10. Neoplasia within the previous 5 years, or without remission
    11. The patient is legally dependent
    12. Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
    13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
    14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
    1. Sospecha de proceso séptico activo en la zona de pseudoartrosis diagnosticado por clínica y analítica.
    2. Pacientes que presenten serología positiva frente a HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) o Lúes (TP-Ac).
    3. Análisis hematológicos y bioquímicos con alteraciones significativas que contraindiquen la participación en el estudio.
    4. Mujeres embarazadas o mujeres sin cobertura anticonceptiva eficaz según criterio del investigador, y mujeres en periodo de lactancia.
    5. Fumador activo de >15 cigarrillos al día.
    6. Enfermedades congénitas óseas (hipofosfatemia), enfermedad metabólica ósea asociada con hipoparatiroidismo primario o secundario.
    7. Diabetes mellitus mal controlada
    8. Diagnóstico de enfermedad vascular periférica arterial.
    9. Irradicación terapéutica previa (5 años anteriores) del hueso afectado.
    10. Enfermedad neoplásica detectada en los últimos cinco años o sin remisión completa.
    11. Paciente legalmente dependiente.
    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 puedan comprometer la participación del paciente en el estudio según criterio médico.
    14. Negación del paciente a ser seguido por un periodo que excede el ensayo clínico en sí.
    E.5 End points
    E.5.1Primary end point(s)
    -Efficacy assessment by TC: quantifying of the Hounsfield units in both treatment arms
    - Evaluación de la eficacia por TC: determinación de las Hounsfield units en el grupo de tratamiento y grupo control.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 12
    A los 12 meses
    E.5.2Secondary end point(s)
    - Safety assessment through physical examination, vital signs, laboratory parameters and adverse events.
    - Efficacy assessment by imaging procedures (TC and x-ray) with pseudarthrosis consolidation assessment in both treatment arms
    - Clinical assessment through quality of life EUROQOL-5D test,
    - 1: Evaluación de la seguridad mediante exploración física, constantes vitales, datos de laboratorio y acontecimientos adversos.
    - 2: Evaluación de la eficacia mediante TC y Rx con determinación de consolidación de la pseudoartrosis en el grupo de tratamiento y grupo control.
    - 3: Evolución clínica de la calidad de vida mediante el test EUROQOL-5D.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -1: At each study visit
    -2: RX at month 1, 2, 3, 4, 5, 6, 9 and 12
    -3: EUROQOL: at month 1, 3, 6, 9 and 12
    -1: En cada visita del estudio.
    -2: RX a los 1, 2, 3, 4, 5, 6, 9 y 12 meses
    -3: EUROQOL: a los 1, 3, 6, 9 y 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.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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    cirugía estandard
    standard surgery
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    LVLS
    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: 20
    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 state20
    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 Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-05
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