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    Summary
    EudraCT Number:2018-004046-41
    Sponsor's Protocol Code Number:273551
    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:2021-12-14
    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 number2018-004046-41
    A.3Full title of the trial
    A multicentre clinical trial; Alveolar bone augmentation using Mesenchymal
    Stem Cells and biphasic calcium phosphate granules prior to dental
    implants
    Ensayo clínico multicéntrico; Aumento de hueso alveolar mediante Células Madre Mesenquimales y gránulos de fosfato cálcico bifásico previo a la colocación de implantes dentales.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the use of the patients own stem cells in combination
    with a biomaterial for jaw bone augmentation
    Estudio para evaluar el uso de las propias Células Madre del paciente en combinación con un material para el aumento del hueso mandibular
    A.3.2Name or abbreviated title of the trial where available
    BEHANDLING
    BEHANDLING
    A.4.1Sponsor's protocol code number273551
    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 SponsorUniversity of Bergen,
    B.1.3.4CountryNorway
    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 supportUniversity of Bergen
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe Research Counsil Of Norway
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversity Complutense de Madrid
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportDensply
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportBiomatlante
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Berguen, Faculty of Medicin, Department of CLinical Dentistry
    B.5.2Functional name of contact pointCecilie Gjerde
    B.5.3 Address:
    B.5.3.1Street AddressAarstadveien 19
    B.5.3.2Town/ cityBergen
    B.5.3.3Post code5009
    B.5.3.4CountryNorway
    B.5.4Telephone number+4755586610
    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 madre mesenquimales y fosfato cálcico bifásico microporoso (MBCP+)
    D.3.2Product code BEHANDLING
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    Dental use
    Periodontal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous Bone Marrow-derived mesenquimal stem cells
    D.3.9.3Other descriptive nameHUMAN AUTOLOGOUS MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB180295
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000000 cells/ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMicroporous Biphasic Calcium Phosphate (MBCP+)
    D.3.9.3Other descriptive nameCALCIUM PHOSPHATE BP
    D.3.9.4EV Substance CodeSUB178495
    D.3.10 Strength
    D.3.10.1Concentration unit ml/cm2 millilitre(s)/square cm
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 cm3 biomaterial
    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 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
    Patients in need of dental implant(s) in the upper and lower jaws with
    presence of bone defects with loss in vertical height and < than 4 mm in
    lateral width
    Pacientes que necesiten implantes dentales en los maxilares con la presencia de defectos óseos con pérdida de altura vertical y que presenten menos de 4 mm de anchura de la cresta.
    E.1.1.1Medical condition in easily understood language
    Lack of bone width (and sometimes hight), so that it is not possible to
    place dental implants.
    Defecto de anchura de hueso (y a veces, en altura), que imposibilita la colocación de implantes dentales
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    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
    Principal objective: placement of dental implants in bone regenerated
    with a combination of autologous culture expanded mesenchymal stem
    cells and biomaterials.The principal objective is to assess if it is possible
    to insert an implant in the reconstructed area 5 months after the
    grafting procedure. This decision will be made based on radiological
    examination of bone volume and bone quality by means of 3D CBCT
    images captured immediately prior to implant placement, 5-6 months
    after the regenerative surgery
    El objetivo principal de este estudio es la colocación de implantes dentales en hueso regenerado con una combinación de células madre mesenquimales expandidas en cultivo y biomateriales. La finalidad es evaluar si es posible insertar un implante en la zona reconstruida 5 meses tras el procedimiento de injerto. Esta decisión se realizará basándose en el examen radiográfico del volumen de hueso y la calidad ósea mediante imágenes 3D obtenidas con un CBCT inmediatamente antes de la colocación de los implantes y 5-6 meses después de la cirugía regenerativa.
    E.2.2Secondary objectives of the trial
    Evaluate new bone formation at 5-6 months assessed by clinical
    examination and CBCT.
    Evaluate the safety of the tested interventions by assessing adverse
    effects and soft tissue healing at 2 and 4 weeks and 5 months. Assess
    the morbidity with the procedure by measuring postoperative
    antiinflammatory
    medication and the degree of reported pain using a VAS
    scale.
    Assess patient's satisfaction with the surgical intervention and the
    prosthetic outcome by patient reported outcomes. The impact of the test
    treatments on the patient's overall quality of life will be assessed.
    Assess the fate of the transplanted MSCs by liquid biopsy technology at
    screening, and 2 weeks after the bone augmentation surgery.
    Bone promoting activity of the interventions by evaluating the core
    biopsies harvested during re-entry procedure at the sites by
    microcomputed
    tomography and histology.
    Evaluate the effectiveness of the interventions
    Evaluar la nueva formación ósea a los 5-6 meses mediante examen clínico y evaluación mediante CBCT.
    Evaluar la seguridad de la intervención test evaluando los efectos adversos y la cicatrización del tejido blando a las 2 y 4 semanas y 5 meses. Evaluar la morbilidad mediante el registro de la medicación anti-inflamatoria postoperatoria y el grado de dolor reportado por el paciente mediate la escala de VAS.
    Valorar la satisfacción del paciente con la intervención quirúrgica y el resultado prostodóntico a través de las variables basadas en el paciente. Valorar el impacto del tratamiento test sobre la calidad de vida del paciente.
    Valorar el destino de las células trasplantadas mediante biopsia líquida en la visita inicial y 2 semanas tras el procedimiento.
    Valorar la actividad promotora ósea mediante biopsia de núcleo de hueso, aisladas durante la re-entrada de las zonas regeneradas mediante tomografía microcomputerizada e histología.
    Evaluar la efectividad de las intervenciones.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Need an dental implant
    Can understand and sign informed consent
    • Age 18 years or older
    • Insufficient bone ridge width and or height at the recipient site for
    implant placement
    • Healthy oral mucosa, at least 2 mm keratinized
    • Necesidad de tratamiento con implantes dentales.
    • Capacidad para entender y firmar consentimiento informado
    • 18 años o mayor
    • Anchura o altura de cresta ósea insuficiente para la colocación de un implante dental
    • Mucosa oral sana, al menos 2 mm de mucosa queratinizada.
    E.4Principal exclusion criteria
    • General contraindications for dental and/or surgical treatments
    • Thin keratinized mucosa (< 1mm)
    • Inflammatory and autoimmune disease of the oral cavity
    • Uncontrolled diabetes
    • History of malignant diseases
    • Concurrent or previous radiotherapy of head and neck region
    • Concurrent or previous immunosuppressant, bisphosphonate or high
    dose corticosteroid therapy
    • Current Smokers
    • Pregnant or lactating women
    • Women of child bearing age, who are not using a highly effective
    method of birth control
    • Participation in an investigational device, drug or biologics study
    within the last 24 weeks prior to the study start
    * Contraindicaciones generales para tratamiento y/o cirugía dental
    * Mucosa queratinizada fina (<1 mm)
    * Enfermedad inflamatoria y autoinmune de la cavidad oral
    * Diabetes mal controlada
    * Historia de enfermedades malignas
    * Radioterapia actual o pasada en región de cabeza y cuello
    *Tratamiento actual o pasado con inmunosupresores, bisfosfonatos o alta dosis de tratamiento con corticoides.
    * Fumadores
    * Embarazadas o lactantes
    * Mujeres en edad de concebir que no usan un método altamente efectivo para el control de la natalidad.
    * Participación en otro estudio de intervención con dispositivos, fármacos o biológicos en las 24 semanas anteriores al inicio de este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    At the end of the healing period (5-6 months), radiological and clinical
    examinations will be performed to determine whether or not the patient may have one or more dental implants inserted.
    Al final del periodo de cicatrización (5-6 meses), los examenes clínico y radiológico se realizarán para determinar si el paciente puede puede recibir o no uno o más implantes dentales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 5-6 months
    A los 5-6 meses
    E.5.2Secondary end point(s)
    At 21 months
    A los 21 meses
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once the implants have been inserted, periapical radiographs and clinical evaluation will assess the post-surgical follow-up up to 20 months after grafting.
    Una vez que los implantes se han colocados, se harán radiografías periapicales y evaluación clínica para valorar el seguimiento post-quirúrgico hasta los 20 meses tras la cirugía de injertado
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS (última visita del último paciente)
    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
    E.8.9.2In all countries concerned by the trial years3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    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)
    Monitorizing of the treated area for the subsequent 5 years
    Monitorización área tratada 5 años
    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 Decision2021-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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