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    Summary
    EudraCT Number:2006-004817-16
    Sponsor's Protocol Code Number:MACI00206
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-28
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-004817-16
    A.3Full title of the trial
    A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study
    to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI® implant) versus Arthroscopic Microfracture for the
    Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle
    including the Trochlea
    A.4.1Sponsor's protocol code numberMACI00206
    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 SponsorGenzyme Europe B.V.
    B.1.3.4CountryUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameAutologous cultured human chondrocytes
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1 million to cells/cm2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeTissue engineered product (advanced therapy medicinal product)
    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
    Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.
    osteochondritis dissecans lesions that do not require a bone graft.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031231
    E.1.2Term Osteochondritis dissecans
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10007705
    E.1.2Term Cartilage damage
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to demonstrate superior efficacy and evaluate the safety of MACI implant compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years old) with symptomatic articular cartilage defects of the femoral condyle including the trochlea.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    During screening:
    1.Provides written informed consent, and is able to read and understand the language and content of the study material.
    2.Symptomatic focal cartilage defects as defined by KOOS Pain score <55.
    3.Age ≥18 and ≤55 years of age.
    4. Agrees to provide a blood sample at the time of cartilage biopsy during the index arthroscopy for testing of HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis.
    During Index Arthroscopy:
    5.Modified Outerbridge Grade III or IV focal cartilage defect(s) located on the femoral condyles, including the trochlea, that will allow treatment with the same surgical procedure as determined at randomization. Note: concurrent Outerbridge Grade I and II defects are acceptable on the patella or tibia if they remain untreated (or are treated with debridement only) at the time of the arthroscopy and/or arthrotomy.
    6.Cartilage lesions determined by arthroscopy prior to randomization and treatment with at least 1 defect size ≥3.0 cm2 on the femoral condyles and/or the trochlea (including osteochondritis dissecans lesions that do not require a bone graft).
    7.Stable knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to or concurrent with arthroscopy and/or arthrotomy.
    8.Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining). Meniscal repair or resection may be performed either staged or concurrent with the cartilage repair procedure provided that the surgeon is able to confirm that at least 50% of functional meniscus would remain after the corrective meniscal treatment.
    E.4Principal exclusion criteria
    At Screening visit:
    1.Any surgery on the knee joint within 6 months prior to Screening (not including diagnostic arthroscopy).
    2.Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target knee joint.
    3.In the target knee joint, patient requires or has a history of a total meniscectomy or meniscal allograft, or has a bucket handle tear or displaced tear that requires a meniscectomy removing >50% of the meniscus.
    4.Malalignment requiring an osteotomy to correct tibial-femoral or patella–femoral alignment. Retinaculum releases are allowed if indicated to correct patella maltracking.
    5.History of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee joint as diagnosed by clinically appropriate X-rays obtained at the Screening visit or within the previous 12 weeks.
    6.Concomitant inflammatory disease or other condition that affects the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis).
    7.History of septic arthritis in the target knee joint within 1 year prior to Screening.
    8.Current malignancy or treatment for malignancy within the past 5 years, except nonmelanoma skin cancer.
    9.Known history of anaphylaxis to gentamicin or any of the products used in the preparation and use of MACI implant.
    10.Patients who, in the opinion of the investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include but are not limited to:
    Any condition that has potential for negatively impacting intra or post-operative course (including: conditions that could severely impair wound healing, e.g., peripheral vascular disease (PVD); Conditions that limit compliance with rehabilitation program, e.g., unstable or poorly controlled angina; Active infection, including unexplained fever (temperature >38.1°C) or antibiotic therapy within 1 week prior to Screening; Any condition that has potential for significantly limiting patient’s ability to assess post-operative knee function, e.g., PVD with symptomatic claudication; Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study; Patient is currently abusing drugs or alcohol or, in the opinion of the investigator, at high risk for poor compliance.)
    11.Previous investigational drug or device use within 3 months prior to Screening.
    12.Females who are pregnant or lactating at the time of Screening (patients must agree to not become pregnant between the Screening visit and the surgical treatment visit, i.e., arthroscopy for those randomized to treatment with microfracture, and arthrotomy for those randomized to MACI implant treatment).
    13.Ongoing litigation for compensation for musculoskeletal injuries or disorders.
    During Index Arthroscopy:
    14. Modified Outerbridge Grade III or IV defect(s) located on the patella or tibia.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy variable is the change from Baseline to Week 104 for the patient’s KOOS Pain and Function (Sports and Recreational Activities) scores.
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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
    Surgical procedure: Microfracture
    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 EEA20
    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 Information not present in EudraCT
    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
    last visit of the last subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 144
    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 Decision2008-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-20
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