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    Summary
    EudraCT Number:2018-001227-39
    Sponsor's Protocol Code Number:779322
    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:2022-07-15
    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 number2018-001227-39
    A.3Full title of the trial
    A randomized controlled clinical trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to autologous bone block grafting.
    Ensayo clínico controlado aleatorizado para evaluar la eficacia de la combinación de células madre mesenquimales autólogas y un biomaterial en regeneración ósea de los huesos maxilares previo a la colocación de implantes dentales en comparación con el injerto óseo en bloque autólogo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if the use of the patients own stem cells in combination with a biomaterial is as good as the standard treatment, bone transplantation.
    Estudio para evaluar si el uso de las células madre del propio paciente en combinación con un biomaterial es tan eficaz como el tratamiento estándar, el transplante óseo
    A.3.2Name or abbreviated title of the trial where available
    Maxibone
    A.4.1Sponsor's protocol code number779322
    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, Faculty of Medicin, Department of Clinical Dentistry
    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, Faculty of Medicin, Department of Clinical Dentistry
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportInserm UMR 1238, PHY-OS Faculty of Medicine, University of Nantes
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportUniversidad Complutense de Madrid
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportSyddansk Universitet SDU
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHaukeland University Hospital, Clinical trial unit
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversitat Internacional De Catalunya Fundacio Privada
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportAssistance Publique - Hôpitaux De Paris
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportInstitute for Transfusion Medicine and Immunogenetic Ulm, University Hospital Ulm (IKT Ulm) and German Red Cross Blood T
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversitaet Ulm
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBiomatlante
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportStraumann
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Bergen, 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+4755586441
    B.5.6E-mailcecilie.gjerde@uib.no
    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 nameMesenchymal stem cells and microporous Bi-phasic calcium phosphate (MBCP+)
    D.3.2Product code Maxibone-1
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPDental use
    Implantation
    Periosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAXIBONE
    D.3.9.3Other descriptive nameBONE MARROW-DERIVED MESENCHYMAL STEM CELLS 
    D.3.9.4EV Substance CodeSUB194470
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCALCIUM PHOSPHATE BP
    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
    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
    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 implante/s dental/es en el maxilar superior y/o inferior y que presenten defectos óseos con pérdida de altura vertical y/o crestas de menos de 4mm de anchura.
    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 de altura), por lo que no es posible colocar 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: To compare linear changes in bone width between
    the tested interventions aimed for vertical and lateral bone
    augmentation; test (combination of autologous culture expanded
    mesenchymal stem cells and biomaterials) and control groups
    (autologous bone block graft from ramus fixed with osteosynthesis
    screws)
    Objetivo principal: comparar los cambios lineales en anchura ósea entre las intervenciones evaluadas para el aumento óseo horizontal y vertical; grupo test (combinación de células madre mesenquimales autólogas y biomaterials) y grupo control (injerto óseo en bloque de rama mandibular fijado con tornillos de osteosíntesis)
    E.2.2Secondary objectives of the trial
    (1) To evaluate efficacy of treatment and formation of new bone by:
    assessing the possibility to insert an implant 5 months after the grafting procedure (3D CBCT)
    Measuring clinical changes in alveolar bone width.
    evaluating the collected core biopsies using μCT, SRμCT and histology.
    evaluting outcomes after implant placement
    (2) To evaluate the safety of the interventions by:
    assessing adverse effects (AEs) and soft tissue healing at 2 and 4 weeks and 5 months
    assessing the morbidity associated with both procedures by measuring the usage of postoperative anti-inflammatory medication and degree of reported pain using a VAS scale
    assessing fate of the transplanted MSCs by liquid biopsy (blood samples and plasma/sera at screening and 2 weeks after bone augmentation surgery)
    (3) To assess patient’s satisfaction with surgical intervention and prosthetic outcome by patient reported outcomes (PROMs). Impact of treatment on the patient’s overall quality of life (QoL) will be assessed
    (1)Evaluar eficacia del tratamiento y formación de nuevo hueso mediante valoración de: a) Posibilidad de colocar un implante 5 meses tras procedimiento (CBCT 3D); b) medición de cambios clínicos en anchura del hueso alveolar. c) evaluación de biopsias de cilindros tomados (μCT, SRμCT e histología); c) evaluación variables tras colocación del implante dental.
    (2) Evaluar seguridad intervenciones mediante: a) valoración efectos adversos (EA) y cicatrización tejido blando a las 2 y 4 semanas y 5 meses, analizando morbilidad asociada, registrando uso de medicación postoperatoria anti-inflamatoria y grado del dolor reportado por paciente (escala VAS). b)Evaluar destino células MSCs transplantadas mediante biopsia líquida (muestras sangre y plasma/ suero en screening y 2 semanas tras cirugía).
    (3) Valorar satisfacción paciente con intervención quirúrgica y resultado prostodóncico mediante variables basadas en el paciente. Se analizará impacto tratamiento en calidad de vida paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Written informed consent
     Patient should be able to understand and complete the informed consent
     Age 18 years or older
     Insufficient bone ridge width (≤ than 4 mm) and or height at the recipient site for
    titanium dental implant placement
     Patient should be eligible for bone marrow harvest and bone transplant
     Healthy oral mucosa, at least 2 mm keratinized mucosa
     Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2- must be
    referred to their physician for a pregnancy test 1,2 before inclusion in the study. In
    case of a negative preganancy test their physician will be asked to prescribe one of
    the highly effective birth control methods recommended by CTFG 2 which includes:
    1. Combined estrogen and progestogen containing contraceptives that are
    associated with inhibition of ovulation (oral, intravaginal or transdermal).
    2. Progestogen-only hormonal contraceptives associated with inhibition of
    ovulation (oral, injectable or implantable).
    3. Intrauterine devices.
    4. Intrauterine hormone-releasing system.
    5. Bilateral tubal occlusion.
     The WOCBP candidates will only be included in the study if the pregnency tests are
    negative. These patients must continue using the contraceptives until the placement
    of dental implants (5 months after bone augmentation procedure considering that
    pregnancy is not considered as a contraindication for normal dental implant).
     Female candidates that have entered menopause for less than 12 months must also
    be referred to confirm post-menopausal state by testing the level of follicle
    stimulating hormone (FSH).
    * Consentimiento informado por escrito
    - El Paciente debe ser capaz de entender y completar el consentimiento informado.
    - Tener mínimo 18 años de edad
    - Anchura de cresta ósea insuficiente (<4mm) y/o altura en área receptora para la colocación de in implante dental de titanio.
    - El paciente debe poder ser elegible para la toma de médula ósea y transplante de hueso.
    - Mucosa oral sana, con al menos 2mm de mucosa queratinizada
    - Mujeres en edad fértil, definidas por CTFG 2-, deben ser referidas a su médico para que se les realice un test de embarazo 1,2 antes de su inclusión en el estudio. En caso de un test de embarazo negativo, se solicitará a su médico que le prescriba uno de los métodos recomendados altamente efectivos para el control de la natalidad por GTFG 2, que incluyen:
    1. Anticonceptivos basados en estrógeno y progestágenos combinados, que estás asociados con la inhibición de la ovulación (oral, intravaginal o transdérmico)
    2. Anticonceptivos basados en sólo progestágenos asociados con la inhibición de la ovulación (oral, inyectable o implantable)
    3. Dispositivos intrauterinos.
    4. Sistemas de liberación de hormonas intrauterino.
    5. Oclusión tubal bilateral
    - Los candidatos de sexo femenino en edad fértil solo se incluirán en el estudio si los test de embarazo son negativos. Estos pacientes deberán continuar utilizando anticonceptivos hasta la colocación de los implantes dentales (5 meses tras el aumento óseo, considerando que el embarazo no es una contraindicación para los implantes dentales normales)
    - Los candidatos de sexo femenino que hayan entrado en menopausia en los últimos 12 meses deberán ser también referidos para confirmar el estado post-menopáusico mediante la evaluación de la hormona folículo estimulante (FSH)
    E.4Principal exclusion criteria
    General contraindications for dental and/or surgical treatments
    · Contraindications for both bone marrow harvesting and bone grafts:
    o General:
    § Patients with severe bone marrow diseases such as leukemias, lymphomas, and myelodysplastic syndromes.
    § Patients with severe respiratory disease, chronic respiratory failure, medical history of generalized allergic manifestation.
    § Patients with a history of severe osteoporosis.
    § Patients suffering from any serious coagulation disorders that could require substitution therapy.
    § Patients receiving anticouagulant treatment should be adjusted in collaboration with the treating physician.
    § Patients with total hip prothesis
    o Local:
    § Patients with active infection at the harvest site
    § Patients with previous pathology or trauma at the harvest site
    · History of any malignant diseases
    · Concurrent or previous radiotherapy of head and neck region
    · History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
    · Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient`s history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
    · Inflammatory and autoimmune disease of the oral cavity.
    · Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
    · Patients with a history of drug addiction.
    · Patients with known hypersensitivity against paracetamol, codein or xylocaine.
    · Thin keratinized mucosa (< 1mm)
    · Current smokers and those who have quitted smoking in the last 4 weeks (there is evidence that nicotine and cotinine levels disappear after 4 weeks of non-smoking).
    · Pregnant or lactating women.
    · Participation in an investigational device, drug or biologics study within the last 24 weeks prior to the study start
    Contraindicaciones generales para los tratamientos dentales y/o quirúrgicos
    Contraindicaciones para el aislamiento de médula ósea e injertos óseos.
    *General:
    - Pacientes con enfermedades avanzadas en la médula ósea, como leucemias, linfomas y síndromes mielodisplásicos.
    - Pacientes con enfermedades respiratorias avanzadas, fallo respiratorio crónico, historia médica de manifestación alérgica generalizada.
    - Pacientes con historia de osteoporosis avanzadas.
    - Pacientes que sufren de alguna alteración seria de la coagulación que requeriría terapia de sustitución.
    - Los pacientes que reciben tratamiento antiguagulante se tratarán en colaboración con su médico para ajustar dicho tratamiento.
    - Pacientes con prótesis completas de cadera.
    * Locales:
    - Pacientes con infección activa en el área donante para el injerto.
    - Pacientes con patología previa o traumatismo en el área donante.
    - Historia de enfermedades malignas
    - Radioterapia previa de cabeza y cuello actual o previa.
    - Historia de enfermedades infecciones (seropositivo VIH, HTLV y/o sífilis, infección por hepatitis B o C)
    - Diabetes Mellitus no controlada; por ejemplo, pacientes con diabetes que no estén controlados con medicación o dieta. El control se verificará mediante la historia del paciente y los niveles actuales de hemoglobina glicosilada (HbA1c<53mmol/mol)
    - Enfermedades autominmunes e inflamatorias de la cavidad oral.
    - Terapia actual o previa con inmunosupresores, bhsfosfonatos o altas dosis de corticoids.
    - Pacientes con historia de drogadicción
    - Pacientes con alergia al paracetamol, codeína o xilocaína.
    - Fina banda de mucosa queratinizada (<1mm)
    - Fumadores actuales y aquellos que hayan dejado de fumar en las últimas 4 semanas (hay evidencia de que los niveles de nicotina y cotidina desaparecen 4 semanas después de dejar de fumar)
    - Mujeres embarazadas o en periodo de lactancia
    - Participación en otro estudio sobre dispositivos de investigación, biológicos o fármacos en las 24 semanas previas al inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Principal assessment is linear change in bone width 2 mm below alveolar crest measured by
    means of CBCT images from baseline to 5 months after the regenerative surgery, immediately
    prior to implant placement.
    La evaluación principal es el cambio lineal en la anchura ósea 2mm por debajo de la cresta alveolar, medido mediante imágenes de CBCT entre la visita inicial y 5 meses tras el procedimiento regenerative, inmediatamente antes de la colocación del implante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 5,5 +- 14 days
    Tras 5,5 meses +- 14 días
    E.5.2Secondary end point(s)
    PROMS, implant stability, QoL, AE assessment
    Variables basadas en el paciente, estabilidad del implante, calidad de vida del paciente, evaluación de eventos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 21 months.
    A los 21 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) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Transplante de hueso
    Bone transplantation
    E.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 150
    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)
    Standard operating procedures for these patients
    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 Decision2020-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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