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    Clinical Trial Results:
    BOne marrOw transfer to enhance ST-elevation infarct regeneration-2

    Summary
    EudraCT number
    		 2005-000774-46
    Trial protocol
    		 DE  
    Global end of trial date
    24 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Sep 2021
    First version publication date
    16 Sep 2021
    Other versions
    Summary report(s)
    		 Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    BOOST-2
    Additional study identifiers
    ISRCTN number
    		 ISRCTN17457407
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hannover Medical School
    Sponsor organisation address
    Carl-Neuberg-Str. 1, Hannover, Germany, 30625
    Public contact
    Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    Scientific contact
    Prof. Dr. K. Wollert, Hannover Medical School, EudraCT@mh-hannover.de
    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
    10 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To demonstrate the efficacy of low-dose intracoronary bone marrow cell (BMC) therapy in improving left ventricular function (left ventricular ejection fraction, LVEF) determined by magnetic resonance imaging (MRI) in patients with ST-elevation myocardial infarction (STEMI) at 6 months. • To demonstrate the efficacy of radiated BMC prior to intracoronary BMC therapy in improving left ventricular function determined by MRI in patients with ST elevation myocardial infarction at 6 months.
    Protection of trial subjects
    not applicable
    Background therapy
    		 Previous regular cardiovascular medication was reported by 23 to 44% of patients: beta-blockers (8 to 24%), ACE inhibitors (5 to 19%) and statins (3 to 18%) The cardiovascular medication given during the initial hospital course is summarised in Table 14.; all patients received ASS, and all but one had statin treatment. Further cardiovascular drugs that were given to the great majority of patients were ACE inhibitors, beta-blockers, and clopidogrel. Another frequently prescribed cardiovascular medication were aldosterone inhibitors (roughly one third of patients). For details see Table 14. During the course of the study this picture did not change essentially. A summary of regular cardiovascular medication at week 6, month 6 and 18 is provided in Table 20. For the Safety Population, the respective information about cardiovascular medication is presented in Tables 13, 15 and 21.
    Evidence for comparator
    		 none
    Actual start date of recruitment
    06 Feb 2006
    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
    Germany: 171
    Country: Number of subjects enrolled
    Norway: 17
    Worldwide total number of subjects
    188
    EEA total number of subjects
    188
    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)
    149
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 06.02.2006 to 26.04.2016

    Pre-assignment
    Screening details
    		 patients with acute myocardial infarction

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All bone marrow
    Arm description
    		 Please see CSR and publication attached for details
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bone Marrow (autolog iBMC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infusion
    Dosage and administration details
    Bone marrow transplantation (infusion)

    Number of subjects in period 1
    		All bone marrow
    Started
    188
    Completed
    188

    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
    		 188 188
    Age categorical
    Older 30 years. Please see CSR and publication attached for details
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Älter 30 Jahre
    		 188 188
    Gender categorical
    It is not an endpoint of the study to evaluate gender specific differences of intracoronary BMC therapy after AMI. Therefore consecutive patients will be included in the study, irrespective of their gender. It is expected, that the gender distribution in the study will reflect the gender distribution of the appearance of myocardial infarction, although this assumption might not be fulfilled in the trial. Please see CSR and publication attached for details.
    Units: Subjects
        Female
    		 94 94
        Male
    		 94 94

    End points

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    End points reporting groups
    Reporting group title
    All bone marrow
    Reporting group description
    		 Please see CSR and publication attached for details

    Primary: Change in LVEF from base line to 6 months

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    End point title
    		 Change in LVEF from base line to 6 months [1]
    End point description
    Please see CSR and publication attached for details
    End point type
    Primary
    End point timeframe
    6 months after base line
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see CSR and publication attached for details.
    End point values
    		 All bone marrow
    Number of subjects analysed
    188 [2]
    Units: MRI
    least squares mean (standard deviation)
        BMC
    0 ( 0 )
    Notes
    [2] - please see CSR attached for more information
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24h Adverse events (AE) need to be documented up to 6 weeks after randomization Serious adverse events (SAE) need to be documented throughout the 18 months follow-up period
    Adverse event reporting additional description
    Serious adverse events (SAE) need to be documented throughout the 18 months follow-up period. An electronic AE-case report form needs to be completed and e-mailed to IST GmbH and faxed to PD Dr. Kai C. Wollert within 24 hours of occurrence.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 0%
    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 CSR and publication attached for details.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2007
    Amendment 1 zu Prüfplan V7; Genehmigung PEI 25.10.2007
    09 Aug 2010
    Amendment 2 zu Prüfplan V7; Genehmigung PEI am 06.09.2010

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Feb 2012
    The recruitement of the trial has been halted due to organizational reasons: supply of excipient PBS to manufacturer of verum (MHH-CTC) has been terminated by manufacturer of PBS (Baxter)
    23 Feb 2012

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    patient enrolment slower than expected; majority of patients screened for the trial, LVEF was only slightly reduced; patient population developed only modest adverse LV remodelling and had a good prognosis 6 months after PCI;

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28431003
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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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