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    Clinical Trial Results:
    Lipofilling with MSC enriched fat, a permanent autologous filler?

    Summary
    EudraCT number
    		 2010-023006-12
    Trial protocol
    		 DK  
    Global end of trial date
    16 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2020
    First version publication date
    29 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-023006-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen East, Denmark, 2100
    Public contact
    Stig-Frederik Trojahn Kølle, Rigshospitalet, Copenhagen University Hospital, stigfrederik@gmail.com
    Scientific contact
    Stig-Frederik Trojahn Kølle, Rigshospitalet, Copenhagen University Hospital, stigfrederik@gmail.com
    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 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this clinical trial, is to establish a reproducible and safe method for fat transplantation, that can be used for larger reconstructions. Fat grafts after transplantation will be examined, the residual volume will be evaluated by MR. MSC enriched fat vs. non-MSC enriched fat (control) will be testet.
    Protection of trial subjects
    All subjects received informed consent both before, during and after the surgical procedures and upon follow-up. All subjects were submitted to the Department of Plastic Surgery and Burns and received sufficient pain management. All subjects also received relevant clinical follow-up's and they had the possibility to contact the responsible doctor round the clock during the trial period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Ethical reason, Regulatory reason, Safety, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject were recruited through local advertisement at Rigshospitalet and on the danish web page forsoegsperson.dk

    Pre-assignment
    Screening details
    		 Only healthy subjects were enrolled

    Pre-assignment period milestones
    Number of subjects started
    		 13
    Number of subjects completed
    		 13

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ASCs enriched fat grafts
    Arm description
    		 ASC-enriched fat graft survival vs. the survival of non-enriched fat grafts
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ex-vivo expanded ASCs
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 x 10^6 ASCs mixed with 26 ml adipose tissue = 30 ml total volume. The solution was injected subcutaneously to the back of the upper arm.

    Arm title
    		 Control - non-enriched fat grafts
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Control fat grafts
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subdermal use
    Dosage and administration details
    Pure fat graft

    Number of subjects in period 1
    		ASCs enriched fat grafts Control - non-enriched fat grafts
    Started
    13
    13
    Completed
    10
    10
    Not completed
    3
    3
         Protocol deviation
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Healthy young subjects

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 28.4 (22.0 to 34.8) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 2 2
    BMI
    Units: kg/m2
        arithmetic mean (full range (min-max))
    		 24.7 (23.3 to 26.1) -
    Subject analysis sets

    Subject analysis set title
    Volume retention
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Both the ASC-enriched fat grafts and the non-enriched control grafts were measured by MRI and after excision by histological examination.

    Subject analysis sets values
    		 Volume retention
    Number of subjects
    10
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    28.4 (22.0 to 34.8)
    Gender categorical
    Units: Subjects
        Female
    9
        Male
    1
    BMI
    Units: kg/m2
        arithmetic mean (full range (min-max))
    24.7 (23.3 to 26.1)

    End points

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    End points reporting groups
    Reporting group title
    ASCs enriched fat grafts
    Reporting group description
    		 ASC-enriched fat graft survival vs. the survival of non-enriched fat grafts

    Reporting group title
    Control - non-enriched fat grafts
    Reporting group description
    		 -

    Subject analysis set title
    Volume retention
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Both the ASC-enriched fat grafts and the non-enriched control grafts were measured by MRI and after excision by histological examination.

    Primary: MRI volume measurement

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    End point title
    		 MRI volume measurement
    End point description
    End point type
    Primary
    End point timeframe
    121 days
    End point values
    		 ASCs enriched fat grafts Control - non-enriched fat grafts Volume retention
    Number of subjects analysed
    10
    10
    20
    Units: cm3
        arithmetic mean (confidence interval 95%)
    23.00 (20.57 to 25.43)
    4.66 (3.16 to 6.16)
    23.00 (20.57 to 25.43)
    Statistical analysis title
    		 Paired T-test
    Comparison groups
    ASCs enriched fat grafts v Control - non-enriched fat grafts
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Treated subjects
    Reporting group description
    		 -

    Serious adverse events
    		 Treated subjects
    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
    		 Treated subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    Surgical and medical procedures
    Swelling
    Additional description: Temporary bruising and swelling post OP after a liposuction and lipo-injection procedure was expected and observed in all subjects.
         subjects affected / exposed
    10 / 10 (100.00%)
         occurrences all number
    10

    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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