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    Summary
    EudraCT Number:2015-005140-33
    Sponsor's Protocol Code Number:2015-Adf-L
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005140-33
    A.3Full title of the trial
    Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy- randomized, placebo-controlled, double-blind clinical trial.
    Kan fedtderiverede stamceller (SVF) bruges i behandling af erektiv dysfuntion (ED) hos prostatectomeret mænd- randomiseret, placebokontrolleret, dobbeltblindet klinisk studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can Fat Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy- randomized, placebo-controlled, double-blind clinical trial.
    Kan fedtderiverede stamceller (SVF) bruges i behandling af erektiv dysfuntion (ED) hos prostatectomeret mænd- randomiseret, placebokontrolleret, dobbeltblindet klinisk studie.
    A.3.2Name or abbreviated title of the trial where available
    2015-Adf-L
    2015-Adf-L
    A.4.1Sponsor's protocol code number2015-Adf-L
    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 SponsorOdense Universitets Hospital
    B.1.3.4CountryDenmark
    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 supportOdense Universitetshospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Universitetshospital
    B.5.2Functional name of contact pointOUH
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    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 Information not present in EudraCT
    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 nameATMP: fresh isolated stem cell
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNStromal Vascular Fraction
    D.3.9.3Other descriptive nameHUMAN AUTOLOGOUS MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB180295
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000000
    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.3.11.13.1Other medicinal product typeStromal vascular fraction (SVF)´: preadipocytes, mesenchymal stem cells (MSC), endothelial progenitor cell, T cells, B cells, mast cells as well as adipose tissue macrophages.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntracavernous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erectile Dysfunction
    Impotence of origanic origin
    E.1.1.1Medical condition in easily understood language
    Erectile Dysfunction
    Impotence of origanic origin
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10021550
    E.1.2Term Impotence
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10021551
    E.1.2Term Impotence of organic origin
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Erectile function
    Tolerability
    E.2.2Secondary objectives of the trial
    Cell characterization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • prostatectomy men, no matter what surgical technique that has been used.
    • Age of 18
    • Organic erectile dysfunction (ED), lasting at least 6 months.
    • patients with a preoperative IIEF-5 score greater than 22, and a 5-IIEF score between 5 and 20 (with or without drug potency) / EHS 1 or greater
    • Involved in a monogamous, heterosexual relationship (when the questionnaires are validated for these) at least 3 months in which both parties are motivated to have or attempt intercourse
    • Not interested or not able to use standard medical treatment for erectile dysfunction
    • Do not have sufficient power of standard medical treatment for erectile dysfunction
    • Subcutaneous fat suitable for liposuction at least 120ml
    • Interested to forgo participation in any other study throughout the study, unless prior approval from the sponsor
    • Skills in Danish reading and writing, so that they can answer the questionnaires.
    • The ability to give informed consent.
    • perfomance status 0
    E.4Principal exclusion criteria
    • Men who have had problems with before (general discomfort, intolerance for anesthetizing substances, venous blood clots after prostatectomy) anesthesia during the removal of the prostate.
    • Significant incontinence after prostatectomy. Defined as more than two volumes DGL.
    • Men where pathology study suspect of not free resektionsrande.
    • Men who are in preventive anticoagulant treatment and does not tolerate interruption or replacement therapy fragmin / heparin.
    • Men indicating not having pleasure in sexual intercourse with a partner or themselves.
    • Previous pelvic radiation or surgery beyond prostatectomy.
    • systemic autoimmune disorder
    • Alcohol abuse or other substance abuse.
    E.5 End points
    E.5.1Primary end point(s)
    IIEF5 score at 6 months compared to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    EHS (erective hardness score) score at 6, 12 and 24 months. IIEF score after 12 and 24 months. Adverse reactions. Explorative we will examine the relationships between age, cell dose, stem cell phenotype and effect.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 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 No
    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 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 Yes
    E.8.2.3Other No
    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
    November 2017
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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 different from the expected normal treatment of that condition
    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 Decision2016-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-20
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