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    Clinical Trial Results:
    REGENERATE – AMI

    Summary
    EudraCT number
    		 2010-021277-36
    Trial protocol
    		 DK  
    Global end of trial date
    08 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2019
    First version publication date
    22 Mar 2019
    Other versions
    Summary report(s)
    		 Published

    Trial information

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    Trial identification
    Sponsor protocol code
    REGENERATE – AMI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    JRMO, 5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Prof A Mathur, Queen Mary University of London, a.mathur@qmul.ac.uk
    Scientific contact
    Prof A Mathur, Queen Mary University of London, a.mathur@qmul.ac.uk
    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 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To improve post-infarction myocardial function
    Protection of trial subjects
    Bone Marrow aspiration was under performed under local anaesthetic.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 91
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Denmark: 8
    Worldwide total number of subjects
    100
    EEA total number of subjects
    99
    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)
    77
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started in March 2008 and ended in 2013 and 100 patients were recruited across 3 countries.

    Pre-assignment
    Screening details
    		 Ant MI patients with moderate regional wall abnormality on LV angiogram

    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
    Arm title
    		 Placebo
    Arm description
    		 Plecebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracoronary use
    Dosage and administration details
    10ml

    Number of subjects in period 1 [1]
    		Placebo
    Started
    45
    Completed
    45
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Please see full report with supplementary data attached for in-depth breakdown

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 45 45
    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)
    		 30 30
        From 65-84 years
    		 15 15
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 41 41

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Plecebo arm

    Subject analysis set title
    Placebo arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Change in LV function in the placebo group

    Subject analysis set title
    BMC arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMC intra-coronary

    Primary: Change in Ejection Fraction at 12 month based on advanced cardiac imaging

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    End point title
    		 Change in Ejection Fraction at 12 month based on advanced cardiac imaging
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Placebo arm BMC arm
    Number of subjects analysed
    45 [1]
    55 [2]
    Units: percentage
        number (confidence interval 95%)
    2.8 (-0.5 to 5.0)
    5.0 (-0.5 to 5.0)
    Notes
    [1] - Placebo
    [2] - BCM
    Statistical analysis title
    		 Paired T test
    Comparison groups
    BMC arm v Placebo arm
    Number of subjects included in analysis
    100
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 ANOVA
    Parameter type
    		 pvalue
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event were reported at 3 months, 6 months and yearly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see full report attached for all details of events

    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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