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    Clinical Trial Results:
    Pilot study investigating the effect of intra-coronary and intra-myocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy

    Summary
    EudraCT number
    		 2009-013103-63
    Trial protocol
    		 DE  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Oct 2020
    First version publication date
    09 Oct 2020
    Other versions
    Summary report(s)
    		 Final Report-2009-013103-63-#1884-AlsterMACS

    Trial information

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    Trial identification
    Sponsor protocol code
    1884
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01337011
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Asklepios Kliniken Hamburg GmbH
    Sponsor organisation address
    Ruebenkamp 226, Hamburg, Germany, 22307
    Public contact
    Dr. Kai Jaquet, ASKLEPIOS proresearch, +49 040181885-3034, k.jaquet@asklepios.com
    Scientific contact
    Dr. Kai Jaquet, ASKLEPIOS proresearch, +49 040181885-3034, k.jaquet@asklepios.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
    02 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety, feasibility, and efficacy of intra-myocardial as well as intra-coronary CD133pos. BM cell therapy on left ventricular ejection fraction as measured by echocardiography.
    Protection of trial subjects
    Whole intervention is done under sedation.
    Background therapy
    		 Standard of care according to medical guidelines at that time
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of 6 patients in 2012 and 4 patients in 2013

    Pre-assignment
    Screening details
    		 Patients with chronic heart disease

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

    Period 1
    Period 1 title
    AlsterMACS (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 intra-coronary application
    Arm description
    		 Intracoronary application of CD133pos. autologous bone marrow derived stem cells
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CD133pos. autologous bone marrow derived stem cells
    Investigational medicinal product code
    Other name
    CD133pos. autologous bone marrow derived stem cells
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intracardiac use
    Dosage and administration details
    single dose

    Arm title
    		 intra-myocardial CD133+
    Arm description
    		 intra-myocardial application of CD133po. cells
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CD133pos. autologous bone marrow derived stem cells
    Investigational medicinal product code
    Other name
    CD133+
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    total number of transplanted CD133+ BMNC = approx. 0.7 - 1.0 Mill. cells per patient

    Number of subjects in period 1
    		intra-coronary application intra-myocardial CD133+
    Started
    8
    2
    Completed
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    intra-coronary application
    Reporting group description
    		 Intracoronary application of CD133pos. autologous bone marrow derived stem cells

    Reporting group title
    intra-myocardial CD133+
    Reporting group description
    		 intra-myocardial application of CD133po. cells

    Reporting group values
    		 intra-coronary application intra-myocardial CD133+ Total
    Number of subjects
    		 8 2 10
    Age categorical
    inclusion criterium age: adults (18-64 years) and adults (65-84 years)
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 2 10
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 8 2 10
    Subject analysis sets

    Subject analysis set title
    CD133+ intramyocardial+intracoronary
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pilot study investigating the effect of intra-coronary and intra-myocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy

    Subject analysis sets values
    		 CD133+ intramyocardial+intracoronary
    Number of subjects
    10
    Age categorical
    inclusion criterium age: adults (18-64 years) and adults (65-84 years)
    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:
        
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    intra-coronary application
    Reporting group description
    		 Intracoronary application of CD133pos. autologous bone marrow derived stem cells

    Reporting group title
    intra-myocardial CD133+
    Reporting group description
    		 intra-myocardial application of CD133po. cells

    Subject analysis set title
    CD133+ intramyocardial+intracoronary
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pilot study investigating the effect of intra-coronary and intra-myocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy

    Primary: safety

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    End point title
    		 safety
    End point description
    no pericardial effusion, no additional hospitalisation, no death
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 intra-coronary application intra-myocardial CD133+ CD133+ intramyocardial+intracoronary
    Number of subjects analysed
    8
    2
    10
    Units: hospitalisation
        number (not applicable)
    0
    0
    0
    Statistical analysis title
    		 paired t-test
    Statistical analysis description
    Analysis of primary hypotheses: The first primary hypothesis - change in ejection fraction between baseline vs. 6months – will be proved using a paired t-test.
    Comparison groups
    intra-coronary application v intra-myocardial CD133+
    Number of subjects included in analysis
    10
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ClinicalTrials.gov
    Dictionary version
    PRV
    Reporting groups
    Reporting group title
    cell therapy group (intra-myo)
    Reporting group description
    		 Cell therapy group (intra-myocardial application of CD133+ BMNC)

    Reporting group title
    cell therapy group (intra-coro)
    Reporting group description
    		 cell therapy group (intra-coronary application of CD133+ BMNC)

    Serious adverse events
    		 cell therapy group (intra-myo) cell therapy group (intra-coro)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 cell therapy group (intra-myo) cell therapy group (intra-coro)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 2 (50.00%)
    Cardiac disorders
    Ventricular arrhythmia
    Additional description: ventricular tachycardia
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    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.
    Due to financial problems and leaving of PI, study had to be cancelled.
    For support, Contact us.
    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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