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    Clinical Trial Results:
    Fat transplantation enriched with ex vivo expanded adipose-derived autologous mesenchymal stem cells in reconstruction of the breast.

    Summary
    EudraCT number
    		 2014-000510-59
    Trial protocol
    		 DK  
    Global end of trial date
    01 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2020
    First version publication date
    19 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01012014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital, Righospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen , Denmark, Dk-2100
    Public contact
    Rigshospitalet, Dept of Plastic Surgery, Breast Surgery & Burns, 45 35453545, Krystztof.T.Drzewiecki@regionh.dk
    Scientific contact
    Rigshospitalet, Dept of Plastic Surgery, Breast Surgery & Burns, 45 35453545, Krystztof.T.Drzewiecki@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    Not relevant
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Ethical reason
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In the process of screening potential participants for inclusion in the clinical study 306 potential candidates responded to our advertisements. Out of these potential candidates 221 women were excluded because they failed to meet the criteria of the study. Additionally 83 women either did not respond or declined to participate in the study.

    Pre-assignment
    Screening details
    		 Most frequent causes for exclusion during screening: Breast ptosis Large breasts Participant not interested after detailed information about the study Age below 30 or above 45 BMI below 22 Previous gastric bypass/gastric sleeve surgery Familiy history of breast cancer

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    ASC enrichment was randomly allocated to the right or left breast of the included participants; their contralateral breast received non-enriched fat grafting (placebo). Allocation ratio between ASC enrichment and placebo was 1:1. The randomisation sequence was generated with www.randomization.com in a single block. An envelope for each participant was opened peroperatively behind a cover by a nurse who prepared the syringes with either ASC enricment or non-enriched fat according to the sequence.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ASC-enriched fat grafts
    Arm description
    		 Fat grafts enriched with autologous ex-vivo expanded adipose-derived stromal cells, injected to the breast
    Arm type
    		 Experimental

    Investigational medicinal product name
    ex vivo expanded adipose-derived stromal cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10 mio cells per mL fat graft, mixed with a fat graft peroperatively

    Arm title
    		 Non-enriched fat grafts (placebo)
    Arm description
    		 non-enriched normal fat grafts injected to the breast
    Arm type
    		 Placebo

    Investigational medicinal product name
    normal fat graft
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    normal fat grafts injected to the breast, no cell enrichment

    Number of subjects in period 1
    		ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASC-enriched fat grafts
    Reporting group description
    		 Fat grafts enriched with autologous ex-vivo expanded adipose-derived stromal cells, injected to the breast

    Reporting group title
    Non-enriched fat grafts (placebo)
    Reporting group description
    		 non-enriched normal fat grafts injected to the breast

    Reporting group values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo) Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 10 20
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 33 (30.3 to 40.0) 33 (30.3 to 40.0) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10 10
        Male
    		 0 0 0
    Mean injected fat graft volume
    Units: millilitre(s)
        median (inter-quartile range (Q1-Q3))
    		 300 (300 to 315) 300 (300 to 315) -

    End points

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    End points reporting groups
    Reporting group title
    ASC-enriched fat grafts
    Reporting group description
    		 Fat grafts enriched with autologous ex-vivo expanded adipose-derived stromal cells, injected to the breast

    Reporting group title
    Non-enriched fat grafts (placebo)
    Reporting group description
    		 non-enriched normal fat grafts injected to the breast

    Primary: 12 months fat graft retention

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    End point title
    		 12 months fat graft retention
    End point description
    Residual volume of injected fat graft to the breast based on MRI
    End point type
    Primary
    End point timeframe
    12 months post-op
    End point values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Number of subjects analysed
    10
    10
    Units: Percent
    arithmetic mean (confidence interval 95%)
        fat graft volume retention
    54.0 (30.4 to 77.6)
    55.9 (28.9 to 82.9)
    Statistical analysis title
    		 Difference in mean retention, 12 months post-op
    Statistical analysis description
    Difference in mean retention, 12 months post-op
    Comparison groups
    Non-enriched fat grafts (placebo) v ASC-enriched fat grafts
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.11
         upper limit
    		 5.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    12.04
    Notes
    [1] - paired t-test

    Secondary: 4 months fat graft retention

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    End point title
    		 4 months fat graft retention
    End point description
    based on MRI
    End point type
    Secondary
    End point timeframe
    fat graft retention in the breast 4 months after surgery
    End point values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Number of subjects analysed
    10
    10
    Units: Percent
    arithmetic mean (confidence interval 95%)
        Fat graft volume retention
    54.3 (39.4 to 69.2)
    56.2 (42.7 to 69.6)
    Statistical analysis title
    		 Difference in mean retention, 4 months post-op
    Comparison groups
    ASC-enriched fat grafts v Non-enriched fat grafts (placebo)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.86
         upper limit
    		 5.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.6
    Notes
    [2] - paired t-test

    Secondary: Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on mammography after 12 months

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    End point title
    		 Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on mammography after 12 months
    End point description
    Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on mammography after 12 months
    End point type
    Secondary
    End point timeframe
    12 months post-op
    End point values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Number of subjects analysed
    10
    10
    Units: Patients
        Oily cysts
    9
    9
        Fat necrosis
    2
    1
        Palpable changes
    3
    2
        Fine needle aspiration cytology + mammography/US
    2
    1
    No statistical analyses for this end point

    Secondary: Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI after lipoinjection to the breast after 4 months

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    End point title
    		 Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI after lipoinjection to the breast after 4 months
    End point description
    Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI four months after lipoinjection to the breast.
    End point type
    Secondary
    End point timeframe
    4 months
    End point values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Number of subjects analysed
    10
    10
    Units: Oily cysts
        Oily cysts
    0
    1
    No statistical analyses for this end point

    Secondary: Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI after lipoinjection to the breast after 12 months

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    End point title
    		 Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI after lipoinjection to the breast after 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 ASC-enriched fat grafts Non-enriched fat grafts (placebo)
    Number of subjects analysed
    10
    10
    Units: Cysts
        Oily cysts
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients were assessed for adverse events after the study intervention 2 weeks, 4 months and 12 months postoperatively
    Adverse event reporting additional description
    Assessment of adverse events took place at our outpatient clinic at Copenhagen University Hospital Rigshospitalet.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    Renal and urinary disorders
    Urinary tract infection bacterial
    Additional description: One trial participant had a urinary tract infection 11 months after study intervention and was admitted to intravenous antibiotics for two days. This event was assessed to have no relation to the intervention in the study.
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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