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    Summary
    EudraCT Number:2022-002175-11
    Sponsor's Protocol Code Number:2021-35
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-06-26
    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 number2022-002175-11
    A.3Full title of the trial
    Safety and potential effect of innovative treatment by adjuvant injection of stromal vascular Fraction from autologous adipose tissue of URethral stenosis with endoscopic urethrotomy: randomized controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and potential effect of innovative treatment by adjuvant injection of stromal vascular Fraction from autologous adipose tissue of URethral stenosis with endoscopic urethrotomy: randomized controlled trial
    A.3.2Name or abbreviated title of the trial where available
    SURF
    A.4.1Sponsor's protocol code number2021-35
    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 SponsorASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHM
    B.5.2Functional name of contact pointPROJECT MANAGER
    B.5.3 Address:
    B.5.3.1Street AddressDRS 80 RUE BROCHIER
    B.5.3.2Town/ cityMARSEILLE
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number33491382747
    B.5.5Fax number33491381479
    B.5.6E-mailalexandra.giuliani@ap-hm.fr
    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 nameFRACTION VASCULAIRE STOMALE AUTOLOGUE
    D.3.2Product code FVS
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    URethral stenosis
    E.1.1.1Medical condition in easily understood language
    URethral stenosis
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 main objective of this study is to assess the safety and tolerability of ADSVF, as add-on treatment to endoscopic urethrotomy for recurrent bulbar urethral stenosis during the follow-up.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to obtain preliminary data on the efficacy of ADSVF injection as add-on treatment to endoscopic urethrotomy on:
    - validated symptoms scores (ICIQ male, USP and Personnal Global impression of Improvement (PGII scale), quantitative functional tests (uroflowmetry and post voiding residual assessment), recurrence rate (need for re intervention on the urethral stenosis) at 1, 3, 6, 9, 18 and 24 months,
    - imaging assessment of spongiofibrosis volume with Fat Sat sequences in an urethral MRI at 1 and 9 months.
    Relationship of efficacy and safety results with imaging, ADSVF composition and biological characteristics will be explored.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed informed consent
    (2) Male, aged from 18 to 85 years
    (3) Bulbar urethral stenosis ≤ 3 cm
    Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study:
    - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through
    - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief
    - Qmax ≤ 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ≠ 0 (Zero)

    (4) At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
    (5) Ability to avoid corticoids or immunosuppressive drugs one month after treatment
    (6) Good general health status according to clinical history and a physical examination
    (7 BMI > 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting
    E.4Principal exclusion criteria
    (1) Urethral stenosis of other location than bulbar
    (2) Urethral stenosis length > 3 cm
    (3) Urethral stenosis on reconstructed penis (transgender, post amputation)
    (4) Prior perineal or pelvic radiotherapy
    (5) Concurent urinary tract infection without treatment
    (6) Concurent perineal infection
    (7) Penile cancer < 5 years
    (8) Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
    (9) Congenital or acquired immunodeficiencies
    (10) Contraindication to the anaesthetic or surgical procedure
    (11) Corticoids or immunosuppressive drugs > 3 months
    (12) Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and Syphillis
    (13) Administrative restricted rights
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3, 6, 9, 18 and 24 months.
    E.5.2Secondary end point(s)
    Secondary endpoints are listed below and will be assessed at baseline 1, 3, 6, 9, 18 and 24 months.
    - Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale.
    - US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan.
    - Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values)
    - Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 6, 9, 18 and 24 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 Yes
    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
    a procedure of endoscopic urethrotomy (standard care)
    E.8.2.4Number of treatment arms in the trial2
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state20
    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 Decision2022-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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