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    The EU Clinical Trials Register currently displays   37220   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-003470-27
    Sponsor's Protocol Code Number:NL-67161-041.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-003470-27
    A.3Full title of the trial
    Randomized controlled trial on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the IMPACT-treatment of cartilage defects (local damage to the cartilage) of the knee. In this treatment cells are obtained from the cartilage defect (from the damaged cartilage) and mixed with stromal cells from a donor. These cells are obtained and placed back in the defect during a single surgery. The primary goal of this study is to determine the effect of the IMPACT-treatment on pain and function of the knee.
    A.3.2Name or abbreviated title of the trial where available
    Instant MSC Product accompanying Autologous Chondron Transplantation 2 (IMPACT2)
    A.4.1Sponsor's protocol code numberNL-67161-041.18
    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 SponsorUMC Utrecht
    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 supportZonMw
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointKnee Mobility Clinic
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ city3584CX
    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 AuthorisationNetherlands
    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 nameInstant MSC Product accompanying Autologous Chondron Transplantation (IMPACT)
    D.3.4Pharmaceutical form Implantation paste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    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. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Cartilage defect of the femoral condyle or trochlea
    E.1.1.1Medical condition in easily understood language
    Local cartilage damage in the knee
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    The primary objective of this study is to compare the level of clinical
    improvement at 3, 6 and 9 months after treatment of a focal articular
    cartilage lesion in the knee with IMPACT to the standard conservative treatment
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate structural cartilage tissue repair.
    Other objectives are:
    1. To evaluate clinical safety of the IMPACT therapy by active tracing of
    the adverse event rate observed after IMPACT therapy and determining
    if this is non-inferior to ACI treatment and does not lead to serious
    adverse event i.e. a local or general immunological response.
    2. To assess the healthcare use and costs related to the procedure as
    well as the health-related work leave during the study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provides written informed consent, is able to understand the content
    of the study, understands the requirements for follow-up visits and is
    willing to provide the required information at follow-up visits and in the
    - Symptomatic articular cartilage lesion of the knee (femoral condyles
    or trochlea).
    - Age >18 and <45 years old
    - Modified Outerbridge Grade III or IV isolated cartilage lesion of the
    - A post-debridement size of the cartilage lesion > 2cm2 and ≤ 8 cm2
    - At least 50% of functional meniscus remaining. Meniscal repair or
    resection is allowed during the IMPACT surgery provided that the
    surgeon is able to confirm that at least 50% of functional meniscus
    - Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).
    E.4Principal exclusion criteria
    - Malalignment of >5 degrees
    - (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as
    determined from appropriate X-ray.
    - Concomitant inflammatory disease that affects the joint (rheumatoid
    arthritis, metabolic bone disease, psoriasis, gout, symptomatic
    - (History of) Septic arthritis.
    - (History of) Total menisectomy in the target knee joint.
    - Any surgery in the knee joint 6 months prior to study inclusion.
    - Risk groups for MRI scanning due to the magnetic field like patients
    with pacemakers, nerve stimulators, metal particles, stents, clips or
    implants, (possible) pregnancy or breast feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical improvement and quality of life as measured with (subscales of)
    the KOOS and the EQ5D, respectively
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12 and 18 months postoperatively
    E.5.2Secondary end point(s)
    The secondary objective is structural repair of cartilage tissue in the
    knee. This will be assessed by MRI at 6 and 18 months postoperatively.
    For safety, a full, per patient, description of each AE will be recorded
    including the nature, date and time of onset, date or resolution,
    determination of seriousness, severity, action taken, outcome and
    causality to study treatment. Specific AEs of interest will be filed in a
    similar manner as AEs using separate scoring forms. If indicated, tissue
    vigilance will be reported to the Transfusion Reaction in Patients (TRIP)
    National Hemovigilance Office.
    Healthcare use and costs related to the procedure as well as the healthrelated
    work leave will be assessed using iMTA questionnaires.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12, and 18 months postoperatively
    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 Yes
    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. 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. description
    Conservative advises (option for physical therapy and pain medication)
    E.8.2.4Number of treatment arms in the trial2
    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
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial 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: 60
    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 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 state60
    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)
    Patients in the control group are given the option to receive IMPACT treatment after 9 months. In that case they will be monitored like the study group was.

    After completion of the last follow-up (18 months), subjects will be
    asked permission to be monitored at 3 and 5 years for long termeffects
    by questionnaires. Patients will receive instructions to return to
    the outpatient clinic if they develop new symptoms of the treated knee
    or if they are in doubt regarding the effect of treatment.
    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 Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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