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    Clinical Trial Results:
    Randomised Control Trial To Compare The Effects Of G-CSF And Autologous Bone Marrow Progenitor Cells Infusion On Quality Of Life And Left Ventricular Function In Patients With Heart Failure Secondary to Ischaemic Heart Disease- REGENERATE-IHD

    Summary
    EudraCT number
    		 2005-002706-27
    Trial protocol
    		 GB  
    Global end of trial date
    08 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2017
    First version publication date
    09 Sep 2017
    Other versions
    Summary report(s)
    		 Regen IHD results

    Trial information

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    Trial identification
    Sponsor protocol code
    Reda 005286
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00747708
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Jessry Veerapen, Barts Health NHS Trust, 44 2037658708, dj.veerapen@bartshealth.nhs.uk
    Scientific contact
    Prof Anthony Mathur, Queen Mary University, 44 2037658704, 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
    26 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether peripheral mobilisation of autologous stem cells and intracardiac administration of the mononuclear fraction of bone marrow derived cells will lead to an improvement in symptoms and cardiac function in patients with heart failure
    Protection of trial subjects
    Data Protection Act Data Safety Monitoring Committee
    Background therapy
    		 Standard treatment for heart failure secondary to ischaemic heart disease as per National and European standards.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2005
    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: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    54
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started in 2005 with the first patient consented in May 2005. The last patient was recruited in June 2011. A total of 90 patients successfully completed the trial assessments.

    Pre-assignment
    Screening details
    		 1133 patients were screened for eligibility, 105 consented but only 90 patients treated on the trial. 1028 patients were excluded and the breakdown is as follows: Normal LV EF n=236, Valvular disease n= 32, Non- ischaemic HF n=79, renal function n=24, RIP n=53, AF n=27, No ICF n=389, other co-morbidities n=188.

    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
    Blinding implementation details
    Randomisation was performed via a dedicated electronic software to either one of the 3 arms of the study (Peripheral, Intracoronary, Intramyocardial). Within each arm the patient was randomised to either the placebo or active arm. Participants, research team and analyst were blinded to whether patients received placebo or stem cell but not to which treatment arm they were assigned to.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Peripheral
    Arm description
    		 30 patients randomised to the peripheral arm and were further assigned to either receive placebo or G-CSF. Patients were blinded to the which placebo/active arm but due to haematological response, the researchers would be able to determine the treatment arm they were assigned to.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Arm title
    		 Intracoronary
    Arm description
    		 30 patients were randomised into this arm and further randomised in 1:1 ratio to stem cell versus placebo. Following G-CSF injection, patients underwent a bone marrow procedure. 15 patients were re-infused with stem cell and 15 patients were with serum placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Arm title
    		 Intramyocardial
    Arm description
    		 30 patients were randomised in this arm and further randomised in 1:1 ratio to either receive stem cell or placebo intramyocardial infusions.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Arm title
    		 Peripheral
    Arm description
    		 30 patients randomised to the peripheral arm and were further assigned to either receive placebo or G-CSF. Patients were blinded to the which placebo/active arm but due to haematological response, the researchers would be able to determine the treatment arm they were assigned to.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Arm title
    		 Intracoronary
    Arm description
    		 30 patients were randomised into this arm and further randomised in 1:1 ratio to stem cell versus placebo. Following G-CSF injection, patients underwent a bone marrow procedure. 15 patients were re-infused with stem cell and 15 patients were with serum placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Arm title
    		 Intramyocardial
    Arm description
    		 30 patients were randomised in this arm and further randomised in 1:1 ratio to either receive stem cell or placebo intramyocardial infusions.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Granocytes colony forming factor
    Investigational medicinal product code
    G-CSF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP was administered at 10ug/kg/day for days.

    Number of subjects in period 1
    		Peripheral Intracoronary Intramyocardial Peripheral Intracoronary Intramyocardial
    Started
    15
    15
    15
    15
    15
    15
    Completed
    15
    15
    15
    15
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Patients with symptomatic ischaemic cardiomyopathy and no further treatment options were enrolled and randomised.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 90 90
    Age categorical
    Patient above 18 years of age and less or equal to 80 years.
    Units: Subjects
        18 years >Age <81 years
    		 90 90
    Gender categorical
    5 out of 90 participants were female.
    Units: Subjects
        Female
    		 5 5
        Male
    		 85 85

    End points

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    End points reporting groups
    Reporting group title
    Peripheral
    Reporting group description
    		 30 patients randomised to the peripheral arm and were further assigned to either receive placebo or G-CSF. Patients were blinded to the which placebo/active arm but due to haematological response, the researchers would be able to determine the treatment arm they were assigned to.

    Reporting group title
    Intracoronary
    Reporting group description
    		 30 patients were randomised into this arm and further randomised in 1:1 ratio to stem cell versus placebo. Following G-CSF injection, patients underwent a bone marrow procedure. 15 patients were re-infused with stem cell and 15 patients were with serum placebo.

    Reporting group title
    Intramyocardial
    Reporting group description
    		 30 patients were randomised in this arm and further randomised in 1:1 ratio to either receive stem cell or placebo intramyocardial infusions.

    Reporting group title
    Peripheral
    Reporting group description
    		 30 patients randomised to the peripheral arm and were further assigned to either receive placebo or G-CSF. Patients were blinded to the which placebo/active arm but due to haematological response, the researchers would be able to determine the treatment arm they were assigned to.

    Reporting group title
    Intracoronary
    Reporting group description
    		 30 patients were randomised into this arm and further randomised in 1:1 ratio to stem cell versus placebo. Following G-CSF injection, patients underwent a bone marrow procedure. 15 patients were re-infused with stem cell and 15 patients were with serum placebo.

    Reporting group title
    Intramyocardial
    Reporting group description
    		 30 patients were randomised in this arm and further randomised in 1:1 ratio to either receive stem cell or placebo intramyocardial infusions.

    Primary: Change in Left Ventricular Ejection Fraction

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    End point title
    		 Change in Left Ventricular Ejection Fraction
    End point description
    Patient left ventricular ejection was assessed at baseline and at 12 month via advanced cardiac imaging, i.e. CT or CMR.
    End point type
    Primary
    End point timeframe
    1 year
    End point values
    		 Peripheral Intracoronary Intramyocardial Peripheral Intracoronary Intramyocardial
    Number of subjects analysed
    15
    15
    15
    15
    15
    15
    Units: percentage
        number (not applicable)
    -0.98
    1.1
    4.15
    -1.25
    0.89
    4.99
    Statistical analysis title
    		 Statistical design and analysis
    Statistical analysis description
    A paired T-test to detect any statistically significance of within-group change in LVEF
    Comparison groups
    Peripheral v Intracoronary v Intramyocardial v Peripheral v Intracoronary v Intramyocardial
    Number of subjects included in analysis
    90
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.038
    Method
    		 Paired-T test
    Parameter type
    		 as above
    Point estimate
    4.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 9.6
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event were collected throughout the duration of each subject time on the trial.
    Adverse event reporting additional description
    All events were recorded and reported.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Due to ethics stipulation at the time of study approval, all events were reported were SAE.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2005
    Changes to study criteria to exclude patients with positive virology, AF, does not respond to device, weight >143kg. Addition of pre-med and extra bone marrow sample to be taken for other research.
    01 May 2008
    Change to protocol to add cardiac CT for patients unable to undergo cardiac MRI.
    05 Nov 2008
    Addition of a thymosin bta-4 sub-study was added to explore the mechanism of action by which bone marrow derived stem cells improve cardiac functions.
    14 Oct 2011
    Addition of the angiogenesis study.

    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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