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    Summary
    EudraCT Number:2016-004755-75
    Sponsor's Protocol Code Number:MICROPREP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-004755-75
    A.3Full title of the trial
    Intra articular injection of microfat and platelet-rich plasma in the treatment of knee osteoarthritis : a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intra articular injection of microfat and platelet-rich plasma in the treatment of knee osteoarthritis : a pilot study
    A.3.2Name or abbreviated title of the trial where available
    MICROPREP
    A.4.1Sponsor's protocol code numberMICROPREP
    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 SponsorClinique Juge
    B.1.3.4CountryFrance
    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 supportClinique Juge
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinique Juge
    B.5.2Functional name of contact pointMarie Laure LOUIS
    B.5.3 Address:
    B.5.3.1Street Address116 rue jean mermoz
    B.5.3.2Town/ cityMARSEILLE
    B.5.3.3Post code13008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33687480679
    B.5.6E-maillouis.marielaure@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 nameautologous Microfat
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    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) 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
    knee osteoarthritis
    E.1.1.1Medical condition in easily understood language
    knee osteoarthritis
    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 demonstrate the efficacy of
    intra-articular injection of autologous microfat associated with a
    standardized preparation of autologous PRP, by changes in the cartilage
    relaxation time on MRI T2-mapping at 3 months.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to follow:
    • Improved chondral lesions at 3 months and 6 months on specific MRI
    cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping):
    quantitative morphological sequences resolution and qualitative
    structural sequences.
    • The evolution of the functional impact of knee osteoarthritis (WOMAC
    score, range of motion), compared to the initial state (scores at
    baseline) and the evolution of pain (VAS score) at 15 days, 1, 3 and 6
    months post-injection.
    • The proportion of patients not responding to treatment.
    • The relationship between clinical efficacy and dose of PRP
    administered and dose of growth factors administered.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females between 20 to 65 years of age
    2. Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4
    3. BMI between 20 to 30
    4. Written informed consent, signed by patient or legal representative
    (if patient unable to sign).
    5. HB > 10g/dl
    6. Negative pregnancy test
    7. Social security affiliated
    E.4Principal exclusion criteria
    1. IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
    2. BMI < 20
    3. Thrombocytopenia < 150 G/L
    4. Thrombocytosis > 450 G/L
    5. Thrombopathy
    6. TP < 70%
    7. TCA patient / witness rapport > 1,20
    8. Anaemia: HB < 10g/dl
    9. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
    10. Treatment by platelet inhibiting agent, aspirin, anti vitamin K completed more than 2 weeks before inclusion
    11. Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
    12. Intra articular knee injection of corticosteroid more than 8 weeks before inclusion
    13. Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion
    14. NSAI treatment completed more than 2 weeks before inclusion
    15. Fever or recent disease
    16. Auto immune disease
    17. Inflammatory Arthritis
    18. Immune deficit
    19. Infectious disease
    20. Malignant tumor being treated or history of malignant tumor
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to demonstrate the efficacy of
    intra-articular injection of autologous microfat associated with a
    standardized preparation of autologous PRP, by changes in the cartilage
    relaxation time on MRI T2-mapping at 3 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 months
    E.5.2Secondary end point(s)
    Secondary objectives are to follow:
    • Improved chondral lesions at 3 months and 6 months on specific MRI
    cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping):
    quantitative morphological sequences resolution and qualitative
    structural sequences.
    • The evolution of the functional impact of knee osteoarthritis (WOMAC
    score, range of motion), compared to the initial state (scores at
    baseline) and the evolution of pain (VAS score) at 15 days, 1, 3 and 6
    months post-injection.
    • The proportion of patients not responding to treatment.
    • The relationship between clinical efficacy and dose of PRP
    administered and dose of growth factors administered.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 15 days, 1,3 and 6 months
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 30
    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 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 state30
    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 Decision2017-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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