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    Summary
    EudraCT Number:2017-004143-21
    Sponsor's Protocol Code Number:OA-orMSCp-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-08-16
    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 number2017-004143-21
    A.3Full title of the trial
    Efficacy of autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects.
    A randomized, controlled, open-label, multi-centre clinical trial.
    Účinnost autologních mezenchymálních kmenových buněk z kostní dřeně na 3D nosiči v léčbě poškození kolenní chrupavky. Randomizovaná, kontrolovaná, otevřená, multicentrická klinická studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of bone marrow-derived stem cells in treatment of knee cartilage defects.
    Účinnost kmenových buněk z kostní dřeně na 3D nosiči v léčbě poškození kolenní chrupavky.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of BM-MSC seeded on a 3D scaffold in knee cartilage defects.
    A.4.1Sponsor's protocol code numberOA-orMSCp-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 SponsorBioinova, a.s.
    B.1.3.4CountryCzechia
    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, a.s.
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioinova, a.s.
    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.5.3.4CountryCzechia
    B.5.4Telephone number+420739385222
    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.3.9.3Other 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 27.0
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10007705
    E.1.2Term Cartilage damage
    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 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 10028395 - Musculoskeletal and connective tissue disorders
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy: To compare the treatment efficacy of a combination of conventional microfracture and autologous MSC seeded onto the acellular 3D scaffold as compared to the commonly used method of microfracture and application of the scaffold alone, in subjects with knee joint chondral lesion.
    E.2.2Secondary objectives of the trial
    Safety: To confirm the safety of autologous MCS administration, as has previously been demonstrated in other orthopaedic indications (rotator cuff, revision hip arthroplasty, posterolateral spinal fusion etc.).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients of either sex, age between 18 and 55 years.
    2. Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration.
    3. Defect is located in the weigh-bearing part of femoral condyle.
    4. Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold).
    5. Isolated chondral defect with a maximum size of 6 cm2.
    6. No previous knee surgery due to a treatment of a chondral defect.
    7. Preoperative level of hemoglobin at least 110 g per L.
    8. Preoperative level of platelet count higher than 150 000 per mL.
    9. Sexually active, nonsterile female patients need to use highly effective contraception during the whole study.
    10. Able to provide written informed consent.
    E.4Principal exclusion criteria
    1. 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 planned knee surgery). 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, diabetes and other serious 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. BMI higher than 40.
    8. Clinical instability of the knee joint.
    E.5 End points
    E.5.1Primary end point(s)
    1) Lysholm score (comparison of score changes between the study arms).
    2) KOOS value (comparison of score changes between the study arms).
    3) Pain according to VAS (comparison of score changes between the study arms).
    4) X-ray and MRI evaluation
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months after treatment administration
    E.5.2Secondary end point(s)
    1) Lysholm-Tegner knee function score
    2) KOOS value
    3) Pain according to VAS
    4) X-ray and MRI evaluation.
    5) Adverse event profiles
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Lysholm score, at 3, 6 and 12 months after treatment administration
    2) KOOS value, at 3 , 6 and 12 months after treatment administration
    3) Pain according to VAS, at 6 weeks, 3, 6 and 12 months after treatment administration
    4) Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months after treatment administration
    5) X-ray and MRI evaluation at 12 months after treatment administration.
    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
    hyalofast® (medical device)
    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 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 years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 40
    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 state40
    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 Decision2020-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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