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    Summary
    EudraCT Number:2014-000510-59
    Sponsor's Protocol Code Number:01012014
    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:2014-06-30
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-000510-59
    A.3Full title of the trial
    Fat transplantation enriched with ex vivo expanded adipose-derived autologous mesenchymal stem cells in reconstruction of the breast.
    Fedttransplantation beriget med opformerede adipøst-deriverede autologe mesenkymale stamceller til rekonstruktion af brystet.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fat transplantation enriched with expanded adipose-derived autologous mesenchymal stem cells in reconstruction of the breast.
    Fedttransplantation beriget med opformerede adipøst-deriverede autologe stamceller til genskabelse af et bryst.
    A.4.1Sponsor's protocol code number01012014
    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 SponsorDept of Plastic Surgery, Breast Surgery & Burns
    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 supportRigshospitalet, Head and Ortopaedic Centre
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept of Plastic Surgery, Breast Surgery & Burns
    B.5.2Functional name of contact pointRigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453545
    B.5.6E-mailKrystztof.T.Drzewiecki@regionh.dk
    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 nameAutologous adipose-derived stem cells
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
    D.3.9.4EV Substance CodeSUB30158
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will include participants with breast hypoplasia (International Classification of Diseases-10: DQ 838A).
    Studiet vil inkludere forsøgspersoner med brysthypoplasi.
    E.1.1.1Medical condition in easily understood language
    The study will include participants with breast hypoplasia.
    Studiet vil inkludere forsøgspersoner med brysthypoplasi.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049070
    E.1.2Term Breast hypoplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the trial is to examine whether enrichment of a fat graft with autologous ASC injected into the breast tissue using traditional technique of ‘small aliquot-injection’ will significantly improve take of the graft and the result of a breast augmentation. The trial will compare fat grafting enriched with ex vivo expanded stem cells to the conventional fat grafting.
    Formålet med studiet er at undersøge hvorvidt berigelse af et fedttransplantat med opformerede autologe adipøst-deriverede stamceller øger overlevelsen af et fedttransplantat efter injektion i et underudviklet bryst. Hvis dette viser sig at være tilfældet forventes det, at resultaterne at kan anvendes til at forbedre den aktuelle behandling af patienter med tidligere brystkræft.
    E.2.2Secondary objectives of the trial
    Screening of radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI and mammography.
    Screening af radiologiske forandringer i brystet efter konventionel og stamcelleberiget fedttransplantation foretaget ved MR skanning og mammografi.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Proliferation of ASC (adipose-derived stem cells) with outdated pooled human platelet lysate (pHPL)
    E.3Principal inclusion criteria
    1. Age 30 - years (incl. 30 and 45)
    2. Healthy females
    3. BMI 22 - 30 kg/m2 (incl. 20 and 30)
    4. 1500 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
    5. Desire for breast augmentation with 300 ml in each breast
    6. Symmetric breast hypoplasia
    7. Speaks and reads Danish
    8. Signed informed consent
    1. 30-45 år
    2. Raske kvinder
    3. BMI (body mass index) 22-30 kg/m2
    4. 1500 mL fedtvæv tilgængelig for fedtsugning på mave, hofter og/eller lår
    5. Ønske om en brystforstørrende operation med brug af 300 ml fedtvæv i hvert bryst
    6. Ensartet størrelse af bryster
    7. Taler og læser sproget dansk
    8. Informeret samtykke til deltagelse i studiet
    E.4Principal exclusion criteria
    1. Smoking
    2. Previous abdominal surgery or breast surgery
    3. Previous cancer or known breast cancer predisposition
    4. Pregnancy or planned pregnancy within one year after the procedure
    5. Breastfeeding less than 6 months prior to inclusion
    6. Known chronic disease
    7. Pacemaker or other implanted foreign objects
    8. Allergy towards necessary anaesthesia
    9. Current or previous participation in other medical studies
    10. Withdrawal of informed consent
    1. Rygning (Rygeophør senest 6 uger før opstart af forsøget og indtil 1 år efter operationen)
    2. Tidligere operation på mave eller bryster
    3. Tidligere kræftsygdom eller kendt arvelig disposition til kræft, herunder brystkræft
    4. Graviditet eller påtænkt graviditet indenfor 1 år
    5. Amning indenfor de seneste 6 måneder
    6. På forhånd kendt kronisk sygdom
    7. Pacemaker eller andre metalholdige fremmedlegemer i kroppen
    8. Kendt allergi overfor bedøvemidler, der anvendes til fuld bedøvelse under operation
    9. Tidligere eller aktuel deltagelse i andre medicinske lægemiddelforsøg
    10. Tilbagetrækning af samtykke til deltagelse i studiet
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of residual volume of fat transplants as based on MRI one year after lipoinjection to the breast.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The MRI examinations will be performed prior to surgery, immediately after surgery (maximum 30 min) and after 12 months.
    E.5.2Secondary end point(s)
    1. Measurement of residual volume of fat transplants as based on MRI four months after lipoinjection to the breast.
    2. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI four months after lipoinjection to the breast.
    3. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI one year after lipoinjection to the breast.
    4. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on mammography one year after lipoinjection to the breast.
    5. Possible adverse events that do not normally occur in relation to fat grafting to the breast and are not described in the risk assessment of this study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The MRI and physical examinations will be performed prior to surgery, immediately after surgery (maximum 30 min) and after 4 and 12 months.
    Mammography will be performed one month prior to surgery and 12 months after surgery.
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Data assesors, surgeons/radiologist and patients are all blinded. Trippleblinded study.
    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 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
    The Good Clinical Practice Unit of Copenhagen monitors the project.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 14
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    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 state14
    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)
    Clinical examination of the participants will be conducted at our outpatient clinic 8-10 days-, 4 months- and 12 months postoperatively. Additional to the primary study period, follow-up will be conducted after 5 and 10 years and also includes clinical examinations.
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-28
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