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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-003481-18
    Sponsor's Protocol Code Number:CART.III.
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-18
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-003481-18
    A.3Full title of the trial
    PHASE III PROTOCOL COMPARING A MICROFRACTURE TREATMENT TO A CARTIPATCH® CHONDROCYTE GRAFT TREATMENT IN FEMORAL CONDYLE LESIONS
    A.3.2Name or abbreviated title of the trial where available
    CARTIPATCH vs MICROFRACTURE
    A.4.1Sponsor's protocol code numberCART.III.
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTBF
    B.1.3.4CountryFrance, Metropolitan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCARTIPATCH®
    D.3.2Product code CARTIPATCH®
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARTIPATCH®
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Femoral condyles single lesion from trauma or osteochondritis dissequans with invalidant signs
    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
    Compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the Cartipatch® chondrocyte graft-treated groups 18 months post-operatively
    E.2.2Secondary objectives of the trial
    • Clinical examination of the knee (KOOS clinical score) and the correlation between IKDC and KOOS
    • Arthroscopic results of the lesion 18 months post surgery (ICRS)
    • Percentage of hyaline cartilage at 18 months post operative (histological ICRS comparison)
    • Comparison of the treated cartilaginous surfaces 18 months post surgery using MRI
    • Failure rate between the 2 arms (Is considered as a failure: a score lower than 70)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients presenting an osteocartilaginous femoral single lesion, with a traumatic etiology or an osteochondritis dissecans could be included in this trial only if all the following criteria are met:
    • Patients of both sexes, active, between 18 and 45 years.
    • Osteochondritis dissecans, type III or IV following the ICRS classification.
    • Grade 3 or 4 lesion following the ICRS classification.
    • Lesion’s surface (perpendicular measure: L x l) from 2.50 cm2 to 7.00 cm2 measured following debridment during the arthroscopy.
    • Lesion’s depth should not be over 10 mm.
    • Existence of invalidating symptoms, clinically significant (subjective IKDC score lower than 55).
    • No prior surgical treatment of this lesion such as microfracture according to Pridie method or perforation > 4mm validated by MRI and osteochondral autografts or autologous chondrocytes implantation.
    E.4Principal exclusion criteria
    • • Pregnant or breast-feeding women. It will then be required for women in age of giving birth to conduct a pregnancy test before recruiting for the study and to take contraception recognized as efficient.
    • Anaphylactic reaction history to gentamicin and amphotericin B.
    • Femoral osteocartilaginous lesion showing a kissing lesion on the tibial plateau or the patella.
    • Knee varus or valgus > 6°
    • Any symptomatic affection of the patella.
    • Existence of an arthrosis, rheumatoid arthritis or any other articular knee affection (meniscal and ligamentary pathology), which, from the surgeon’s opinion, could potentially compromise the evolution of the treatement.
    • Excessive laxity: Lachman higher than 3 (ICRS). History of one or several crossed ligaments rupture without correction (surgery performed more than 1 year before patient inclusion).
    • Meniscal pathology history concerning 2/3 of meniscus without treatment (surgery performed more than 1 year before patient inclusion).
    • Existence of an ulcerous pathology, tuberculosis, a psychiatrically evaluated pathology or a disease requiring a long-term treatment, including drugs acting on the joint or bone metabolism.
    • Patients suffering present and passed bone, cartilage, muscle or adipose tissue cancer.
    • Patients with positive serological tests for HIV, Hepatitis B and C, HTLV and Syphilis.
    • Patients Body Mass Index higher than 30.
    E.5 End points
    E.5.1Primary end point(s)
    Compare at 18 months the clinical improvement of the IKDC subjective score between the two groups
    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) No
    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
    surgical act
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    overdrowing of the protocol
    additional patients will be included to compensate potential lost of follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 64
    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 Decision2008-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-31
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