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    Summary
    EudraCT Number:2018-004067-31
    Sponsor's Protocol Code Number:OA-orMSCp-02
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-004067-31
    A.3Full title of the trial
    Autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects. Prospective open-label study to assess safety and feasibility.
    Autologní mezenchymálních kmenové buňky z kostní dřeně na 3D nosiči v léčbě poškození kolenní chrupavky. Otevřená klinická studie k určení bezpečnosti a proveditelnosti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of bone marrow-derived stem cells in treatment of knee cartilage defects.
    Bezpečnost kmenových buněk z kostní dřeně v léčbě poškození kolenní chrupavky.
    A.4.1Sponsor's protocol code numberOA-orMSCp-02
    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 SponsorBioinova, s.r.o.
    B.1.3.4CountryCzech Republic
    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 supportBioinova, s.r.o.
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioinova, s.r.o.
    B.5.2Functional name of contact pointHeadquarters
    B.5.3 Address:
    B.5.3.1Street AddressVídeňská 1083
    B.5.3.2Town/ cityPraha 4 - Krč
    B.5.3.3Post code14200
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number420241039361
    B.5.6E-mailpeter.bauer@bioinova.cz
    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 nameHuman autologous mesenchymal stem cells
    D.3.2Product code BiCure ortho MSCp
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracartilaginous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman autologous mesenchymal stem cells
    D.3.9.2Current sponsor codeBiCure ortho MSCp
    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 million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3.5 to 6.5
    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) 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
    Knee Cartilage Defect
    Defekt kolenní chrupavky
    E.1.1.1Medical condition in easily understood language
    Knee Cartilage Damage
    Poškození kolenní chrupavky
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10007710
    E.1.2Term Cartilage injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052913
    E.1.2Term Cartilage operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057104
    E.1.2Term Cartilage repair
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10072638
    E.1.2Term Articular cartilage defect
    E.1.2System Organ Class 100000004859
    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 a single dose of autologous MSC seeded on a commercially available acelullar 3D scaffold and fixed by using autologous blood plasma in the repair of knee chondral lesions.
    E.2.2Secondary objectives of the trial
    To collect preliminary efficacy data from patient administered questionnaires (VAS, KOOS and Lysholm-Tegner scoring scale) and X-ray. To evaluate feasibility of the treatment in current clinical praxis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adult patients of either sex, age between 18 and 60 years.
    2.Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage III, the cause of the defect being either trauma or progressive degeneration.
    3.Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture followed by the application of the 3D scaffold chondrotissue®).
    4.No previous knee surgery due to a chondral defect.
    5.Preoperative level of haemoglobin at least 110 g per L.
    6.Preoperative level of platelet count higher than 150 000 per mL.
    7.Able to provide written informed consent.
    E.4Principal exclusion criteria
    1.Ligament laxity or axial deformities over 10° on the study knee.
    2.Systemic corticosteroid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the screening visit). Intraarticular corticosteroid medication is not allowed within the same time period.
    3.Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, metabolic disorders, drug abuse, etc.).
    4.Concurrent or previous cancer.
    5.Blood, plasma or platelet transfusion during previous 8 weeks.
    6.Pregnant or lactating women.
    7.Subject not using two reliable methods method of birth control.
    8.BMI higher than 40.
    9.Clinical instability of the joint objectified during the surgery.
    E.5 End points
    E.5.1Primary end point(s)
    •Short-term safety: analysis of adverse events, clinically significant abnormal laboratory values and changes in vital signs and physical examinations
    •Long-term safety: analysis of adverse events, clinically significant abnormal laboratory values and changes in vital signs and physical examinations
    •Whole treatment safety: discussion of adverse events potentially occurring after the bone marrow harvest
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Short-term safety: at 1, 3, 6 and 9 months
    •Long-term safety: at 12 and 24 months
    •Whole treatment safety: at the time period before day 0
    E.5.2Secondary end point(s)
    •Lysholm-Tegner knee function score (compared to pre-treatment values)
    •KOOS value (compared to pre-treatment values)
    •Pain according to VAS (compared to pre-treatment values)
    •X-ray (compared to pre-treatment values)
    •Evaluation of patient compliance
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Lysholm-Tegner knee function score, at 6, 12 and 24 months post-operation
    •KOOS value, at 6, 12 and 24 months post-operation
    •Pain according to VAS, at 6, 12 and 24 months post-operation
    •X-ray at 6, 12 and 24 months post-operation (compared to pre-treatment values)
    •MRI at 12 months post-operation to evaluate the healing status of the treated cartilage defect
    •Evaluation of patient compliance at all study visits
    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 No
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 6
    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 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 state6
    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.
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
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