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    Summary
    EudraCT Number:2018-004047-23
    Sponsor's Protocol Code Number:273551-2
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-17
    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 ConcernedNorway - NOMA
    A.2EudraCT number2018-004047-23
    A.3Full title of the trial
    Evaluation of safety and feasibility of autologous MSCs combined to biomaterial to enhance bone healing in patients with delayed consolidation after long bone defects requiring graft apposition or alternative orthobiologics
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate if the patients own stem cells combined with biomaterial will be effective and safe in bone healing in patients with fractures in the leg or arm, that did not heal with conventional treatment.
    En studie for å undersøke om pasientens egne stamceller i kombinasjon med et biomaterial vil være en trygg og effektiv behandling av brudd i arm eller fot der vanlig behandling ikke har ført til tilheling.

    (Norsk språk, var ikke som alternativ)
    A.3.2Name or abbreviated title of the trial where available
    Behandling, Orto
    A.4.1Sponsor's protocol code number273551-2
    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 supportBiomatlante
    B.4.2CountryFrance
    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 AddressÅrstadveien 19
    B.5.3.2Town/ cityBergen
    B.5.3.3Post code5009
    B.5.3.4CountryNorway
    B.5.4Telephone number+4755586610
    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.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Behandling, Ortho
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    Implantation
    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
    Diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus) status delayed union (after 3 months) treated by standard care procedures
    E.1.1.1Medical condition in easily understood language
    Fractures in arm or leg that have not healed after 3 months with conventional treatment.
    Brudd i underarm eller legg som ikke vil gro normalt etter forventet tid.
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    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
    To assess the safety of apposition of biomaterial with autologous MSCs at the fracture site.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The inclusion criteria are:
    - Age 18 to 65, both sexes
    - Traumatic isolated closed or open Gustilo-Anderson I, II or IIIa humerus, tibial, ulna or femur
    - diaphyseal or metaphysodiaphyseal fracture with a bone loss of 2-10 cm.
    - 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
    To further standardize the inclusion, patients to be included will be those that alternatively would have received bone autograft and/or BMPs, thus avoiding (excluding) segmental defect patients to be treated with large allografts.
    E.4Principal exclusion criteria
    The non-inclusion criteria are:
    - Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
    - Participation in another therapeutic trial in the previous 3 months
    - Delayed union or non-union related to iatrogeny
    - Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc)
    - Vascular or neural injury
    - Other fractures causing interference with weight bearing
    - Infection: skin, soft-tissue, bone or any remote infection (dental, pulmonary, gynecological)
    - Visceral injuries of diseases interfering with callus formation
    - (craneoencephalic trauma, etc.)
    - History of bone harvesting on iliac crest contraindicating bone-marrow aspiration
    - Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion
    - History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR)
    - Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility.
    - Impossibility to meet at the appointments for the follow up
    - Insulin dependent diabetes
    - Obesity (BMI > 30)
    - Autoimmune inflammatory disease
    - Current treatment by biphosphonate or stopped in the three months prior to study inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Proven bone healing
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 and 24 weeks
    E.5.2Secondary end point(s)
    - Amount of radiological callus at 12 weeks, and 26 weeks.
    - Clinical consolidation at weeks 12, 24.
    - No reoperation done or scheduled at 26 weeks.
    - Changes in serum levels of bone turnover markers (in a centralized laboratory) at 6, 12 and 26 weeks after treatment: the following markers will be evaluated by immunoenzymatic assays on serum samples on all recruited patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12 and 24 weeks
    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 No
    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 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 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
    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) 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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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 patient in the hospital
    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 Decision2019-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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