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    Summary
    EudraCT Number:2017-004319-37
    Sponsor's Protocol Code Number:001.4
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-20
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-004319-37
    A.3Full title of the trial
    A prospective, randomised, single-blind explorative study to investigate the efficacy and safety of fat graft enrichment with autologous platelet lysate in female breast augmentation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of efficacy and safety of fat transfer for breast augmentation with the addition of autologous blood cells
    A.4.1Sponsor's protocol code number001.4
    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 SponsorMedical University of Vienna, Department of Surgery
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna, Department of Surgery
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Unversity of Vienna, Department of Gynecology
    B.5.2Functional name of contact pointDani Lutfi
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number4306608366680
    B.5.6E-mailDani.lutfi@gmail.com
    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 nameaPL
    D.3.2Product code aPL
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSoft tissue use (Noncurrent)
    Subcutaneous use
    Transdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 Yes
    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
    Fat grafting e.g. to the breast to restore small tissue defects is a very common and safe surgical procedure. Its main success among other is depended on the survival rate of the transferred fat tissue. The survival rate is very unpredictable and varies from 16-70%. This study will examine impact of autologous PRP-Lysate as a enrichment to fat grafts with the assumption to enhance the survival rate.
    E.1.1.1Medical condition in easily understood language
    Fat grafting to the breast has a unpredictable outcome. This study will examine impact of autologous PRP-Lysate as a enrichment to fat grafts with the assumption to enhance the survival rate.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016251
    E.1.2Term Fat tissue increased
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    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 is to evaluate efficacy of enrichment of fat grafts with autologous platelet lysate to enhance the fat graft take potential in women with breast augmentation.
    E.2.2Secondary objectives of the trial
    To assess the safety of autologous platelet-lysate enriched fat graft in women with breast augmentation
    To evaluate if the addition of autologous platelet-lysate enriched fat graft will reduce the incidence of fat necrosis, cyst formation and nodules in women with breast augmentation
    To evaluate the effect of autologous platelet-lysate enriched fat graft on the patient reported quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Female age 18 to 45
    -BMI between 21-28
    -Candidate for bilateral primary breast augmentation – wish to augment breasts
    -Breast cup size at least B
    -Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia)
    -Sufficient knowledge of German or English language to understand trial instructions and ability to comply with treatment
    -The patient has realistic expectations of surgical results after discussion with investigator and is an acceptable candidate for breast augmentation towards investigator judgment
    -Adequate peripheral vein status for pheresis
    -Written on informed consent prior to enrolment
    E.4Principal exclusion criteria
    -History or current diagnosis of breast cancer
    -Women undergoing reconstructive surgery following mastectomy
    -History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years
    -Pregnancy or breast feeding at time of screening
    -Patients with scarred breast tissue, with breast size asymmetry reflected in different breast holder size cups
    -Women with current infection requiring systemic antibiotic treatment
    -Known alcohol, drug or medication abuse
    -The patient participated in an interventional trial within 90 days of enrolment
    -The patient has a severe breast and upper trunk deformity
    -The patients is not willing to undergo further surgery for revision, if medically required
    -Use of any immunosuppresive or immunomodulatiry treatment, chronic use of oral or systemic anticoagulation or antiplatelet therapy
    -Patients with platelet disorders, thrombocytopenia, bone marrow aplasia
    -Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient’s compliance (eg. Patients with diabetes mellitus under treatment, end-stage renal disease and patients on dialysis, patients with severe cardiovascular condition requiring chronic treatment)
    -Laboratory criteria: hemoglobin < 12g/dl, CRP > 5mg/dl, platelets < 150 or > 400 tsd./µl, leucocytes < 4,4 or > 11,3 tsd./µl
    -Blood donation within 4 weeks before study initiation
    -Patients with connective tissue disease OR is currently being evaluated for symptoms suggestive of connective tissue disease
    -Any other condition the investigator believes would interfere with the patient’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk
    E.5 End points
    E.5.1Primary end point(s)
    Breast volume measurement with MRI is a surrogate of fat survival rate. Since interest lies in the clinical relevance of the new treatment, statistical analysis will be performed primarily by the intention-to-treat principle and secondarily by the per-protocol principle. A zero change in fat-survival rate will be imputed for non-available measurements.
    Main outcome parameter is the fat-survival rate at 12 weeks after first surgery, which is a continuous variable. The fat-survival rate will be compared between the aPL and the control treatment using a paired t-test with a 0.05 two-sided significance level. A 95% confidence interval for the mean difference will be computed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Difference in volume at week 1, week 12 and week 24 after first surgery between left and right breast and comparison pre-operatively to the given time-point and time dependent change in volume
    breast volume difference after 2 intervention (1 week to 12 week after second intervention)
    Breast volume at Visit 9
    BREASTQ
    HRQOL
    SAE, AEs, related to study intervention
    PRP comparison with historical group to aPL (Comparison of efficacy of aPL enrichment of fat graft versus efficacy of autologous platelet rich plasma (PRP) enrichment of fat graft to the breast (Comparator-historical group from literature search) in literature comparison.

    Secondary outcome parameters which are measurable at each side will be analysed similarly applying the per-protocol principle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week, 12 weeks
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pure fat graft without the addition of PRP-Lysate
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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.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 No
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-02-20. Yes
    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.3.3.7.1Details of other specific vulnerable populations
    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)
    3 Month of follow up period, oder noch zweite OP nach 3 Monaten.
    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 Decision2019-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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