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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2012-001570-29
    Sponsor's Protocol Code Number:NL4014200012
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001570-29
    A.3Full title of the trial
    Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee; feasibility and safety
    Haalbaarheids en veiligheidsstudie van de Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) voor focale kraakbeendefecten in de knie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to demonstrate safety of a one-stage celtherapy operation using Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for cartilage defects of the knee
    Prospectief, haalbaarheids klinisch interventieonderzoek waarbij de één-stap kraakbeen transplantatie genaamd Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) gebruikt wordt voor de behandeling van een beschadiging van een deel van het kraakbeen in de knie.
    A.3.2Name or abbreviated title of the trial where available
    IMPACT
    IMPACT
    A.4.1Sponsor's protocol code numberNL4014200012
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    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 supportUniversity Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Utrecht
    B.5.2Functional name of contact pointDepartment of Orthopaedics
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887556971
    B.5.6E-maild.saris@umcutrecht.nl
    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 nameInstant MSC Product accompanying Autlogous Chondron Transplantation
    D.3.2Product code IMPACT
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    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 INNautologous chondrocytes with pericellular matrix
    D.3.9.3Other descriptive nameautologous chondrons
    D.3.10 Strength
    D.3.10.1Concentration unit ml/cm2 millilitre(s)/square cm
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNallogeneic bone marrow derived mesenchymal stromal cells
    D.3.9.3Other descriptive nameallogeneic bone marrow derived MSCs
    D.3.10 Strength
    D.3.10.1Concentration unit ml/cm2 millilitre(s)/square cm
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1800000
    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 Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    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
    Articular cartilage defects of the femural condyl and trochlea of the knee
    Kraakbeendefecten in de femurcondyl en trochlea van de knie
    E.1.1.1Medical condition in easily understood language
    Cartilage damage in the knee
    Kraakbeenschade in de knie
    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 examine clinical safety and feasibility of the IMPACT therapy.
    Het primaire doel van deze studie is het aantonen van de klinische veiligheid van de IMPACT therapie.
    E.2.2Secondary objectives of the trial
    The secondary objective is to measure the level of clinical improvement and quality of life at 6, 12 and 18 months.
    De secundaire doelstelling is het meten van het niveau van de klinische verbetering en de kwaliteit van leven op 6, 12 en 18 maanden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18-45 with a cartilage defect in the femoral condyle or trochlea sized 2-8 cm2
    Patiënten 18-45 jaar oud met een kraakbeendefect in de femurcondyl of trochlea van 2-8 cm2.
    E.4Principal exclusion criteria
    Patients with other dieases of the knee joint such as osteoarthritis, inflammatory disease (rheumatoid arthritis, metabolic joint disease, psoriasis and gout and septic arthritis), malalignment and patients with a prior total menisectomy.
    Patiënten met een andere afwijking in de knie zoals artrose, inflammatoire ziekten(reumatoïde artritis, metabolische ziekten, psoriasis, jicht en septische artritis), een standsafwijking (varus/valgus), en patiënten die een totale menisectomie zijn ondergaan.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events/ safety
    Adverse events/ veiligheid
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery, after 1,2,4 and 6 weeks and after 3,6,12 and 18 months.
    Na de operatie, na 1.2.4 en 6 weken en na 3,6,12 en 18 maanden.
    E.5.2Secondary end point(s)
    Clinical outcome and quality of life and structural repair assessed by arthroscopic biopsy and MRI
    Klinische vooruitgang en kwaliteit van leven en structurele regeneratie gemeten met een arthroscpisch geleid biopt en een MRI scan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    clinical outcome and quality of life: 6, 12 and 18 months, structural repair :12 months
    Klinische vooruitgang en kwaliteit van leven na 6,12 en 18 maanden en regeneratie na 12 maanden.
    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 Yes
    E.6.13.1Other scope of the trial description
    feasability
    haalbaarheid
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Fase I/II studie met 1 behandelingsgroep
    Phase I/II safety study single treatment arm
    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.8.2.4Number of treatment arms in the trial1
    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 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
    18 month follow-up after the operation of the final patient
    18 maanden follow-up na de operatie van de laatste patient
    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 months
    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: 35
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Information not present in EudraCT
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    After completion of the last follow-up subjects will be asked permission to be monitored at 3 and 5 years for long-term effects. Subjects will receive instructions to return to the outpatient clinic if any new symptoms of the index knee have developed or if they have any doubt regarding the effects of treatment.
    Na afronding van de laatste controle op 18 maanden zal er toestemming worden gevraagd aan proefpersonen of die na 3 en 5 jaar kunnen worden gecontroleerd voor de lange termijn effecten. Patienten zullen worden geinstrueerd om terug te keren naar de polikliniek van de orthopaedie indien er nieuwe symptomen ontstaan of indien er twijfel bestaat over de behandeling en/ of de huidige toestand van de knie.
    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 Decision2012-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
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