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    Clinical Trial Results:
    Bone marrow-derived mesenchymal stromal cell treatment in patients with severe ischaemic heart failure: a randomized placebo-controlled trial (MSC-HF trial)

    Summary
    EudraCT number
    		 2008-001850-42
    Trial protocol
    		 DK  
    Global end of trial date
    31 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2020
    First version publication date
    07 Apr 2020
    Other versions
    Summary report(s)
    		 MSC CHF summary
    Publication European Heart Journal

    Trial information

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    Trial identification
    Sponsor protocol code
    MSC-HF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00644410
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Jens Kastrup Professor, Department of Cardiology 2014, +45 35452819, jens.kastrup@regionh.dk
    Scientific contact
    Jens Kastrup Professor, Department of Cardiology 2014, +45 35452819, jens.kastrup@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
    30 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    It is a single centre, randomised controlled study of the effect of NOGA guided direct intramyocardial injection of mesenchymal stromal cells on the developement of new myocardium and blood vessels in patients with heart failure. Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium. The patients will be followed for safety, clinical symptoms, MRI and CT for 12 months
    Protection of trial subjects
    The GMP unit in the Capital Region of Denmark monitored the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Apr 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    8
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients followed for Heart failure or referred for an invasive investigation to the Department of Cardiology was screened for participation in the study.

    Pre-assignment
    Screening details
    		 At time of inclusion the patients were on maximum tolerable medication with no changes in medication for two months. Patients had LVEF≤45% and were New York Heart Association (NYHA) Class II-III. Major exclusion criteria were acute coronary syndrome, stroke or transitional cerebral ischemia within six weeks, revascularization within 4 months, moder

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    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
    Yes

    Arm title
    		 Active - MSC
    Arm description
    		 Injection of autologous bone marrow derived mesenchymal stromal cells
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mesenchymal stromal cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracardiac use
    Dosage and administration details
    The patient was treated with the number of cell produced after two cell culture expansion passages : mean of 77.5±67.9 x106 (inter quartile range 53.8x106) MSCs

    Arm title
    		 Placebo
    Arm description
    		 Saline injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracardiac use
    Dosage and administration details
    0.2 ml isotonic NaCl

    Number of subjects in period 1
    		Active - MSC Placebo
    Started
    40
    20
    Completed
    40
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active - MSC
    Reporting group description
    		 Injection of autologous bone marrow derived mesenchymal stromal cells

    Reporting group title
    Placebo
    Reporting group description
    		 Saline injection

    Reporting group values
    		 Active - MSC Placebo Total
    Number of subjects
    		 40 20 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.1 ± 7.7 64.2 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10
        Male
    		 36 14 50

    End points

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    End points reporting groups
    Reporting group title
    Active - MSC
    Reporting group description
    		 Injection of autologous bone marrow derived mesenchymal stromal cells

    Reporting group title
    Placebo
    Reporting group description
    		 Saline injection

    Primary: Left ventricular end-systolic volume

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    End point title
    		 Left ventricular end-systolic volume
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 6 months follow-up
    End point values
    		 Active - MSC Placebo
    Number of subjects analysed
    40
    20
    Units: ml
        geometric mean (confidence interval 95%)
    -7.6 (-11.8 to -3.4)
    5.4 (-0.4 to 11.2)
    Statistical analysis title
    		 difference
    Comparison groups
    Active - MSC v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    baseline to 6 months follow-up
    Adverse event reporting additional description
    There was no serious adverse event due to the mesenchymcal stem cell therapy
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Hospitals reports
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Mesenchymal stromal cell
    Reporting group description
    		 Patients treated with mesenchymal stromal cells

    Reporting group title
    Placebo
    Reporting group description
    		 Patients treated with placebo

    Serious adverse events
    		 Mesenchymal stromal cell Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Mesenchymal stromal cell Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 20 (0.00%)
    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: There were no adverse or serious adverse events that could be related to the treatment.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25926562
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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
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