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    Clinical Trial Results:
    Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction using Bone Marrow Mononuclear Cells</full-title-trial

    Summary
    EudraCT number
    		 2008-004625-42
    Trial protocol
    		 DE  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Oct 2020
    First version publication date
    07 Oct 2020
    Other versions
    Summary report(s)
    		 2008-004625-42-#1777-AlsterStemCells final report

    Trial information

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    Trial identification
    Sponsor protocol code
    KardioPII
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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, k.jaquet@asklepios.com
    Scientific contact
    Dr. Kai Jaquet, ASKLEPIOS proresearch, 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
    25 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Can transendocardial injection of BMNC be used safely in patients with symptomatic heart failure?
    Protection of trial subjects
    Bone marrow aspiration as well as minimal invasive catheter based mapping and cell injection procedure of/into left ventricle were performed under sedation.
    Background therapy
    		 Besides cell therapy treatment patients received optimal standard cardiologic therapy (medication) according to at that time validated medical guidelines.
    Evidence for comparator
    		 The results were compared to a matched control group of revascularised, post-STEMI patients with optimal standard therapy.
    Actual start date of recruitment
    15 Jan 2009
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    21
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between January 2009 and July 2010 all patients admitted to the cardiology department at St. Georg Hospital for acute STEMI were assessed regarding EF following successful revascularisation by pri¬mary percutaneous coronary intervention (PCI). Patients aged <80 years and baseline measurements of EF <45% (CMR) assessed at least one week after PCI wi

    Pre-assignment
    Screening details
    		 EF <45% (CMR) assessed at least one week after PCI with additional symptoms of heart failure (NYHA Class ≥II) as well as NT-proBNP levels >250 pg/ml despite successful revascularisation were eligible.

    Pre-assignment period milestones
    Number of subjects started
    		 23
    Number of subjects completed
    		 23

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 cell therapy arm
    Arm description
    		 Patients receiving BMNC cell therapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bone marrow mononuclear cells (BMNC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intramuscular use, Percutaneous use
    Dosage and administration details
    15-20 injections of concentrated BMNC (100 μl each) were performed; in total, 220±42*106 cells/patient were injected.

    Arm title
    		 control group
    Arm description
    		 control group
    Arm type
    		 Active comparator

    Investigational medicinal product name
    non-treated control group
    Investigational medicinal product code
    Other name
    control group
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracardiac use
    Dosage and administration details
    This is the "Placebo Group". Ethical committee prohibited injection of placebo (saline). Therefore this is a non-treatment goup.

    Number of subjects in period 1
    		cell therapy arm control group
    Started
    12
    11
    Completed
    12
    11

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    cell therapy arm
    Reporting group description
    		 Patients receiving BMNC cell therapy.

    Reporting group title
    control group
    Reporting group description
    		 control group

    Primary: increase of EF

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    End point title
    		 increase of EF
    End point description
    Significant increase of EF (+7.9±1.5%, p=0.001) while the control group showed no Change.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 cell therapy arm control group
    Number of subjects analysed
    12
    11
    Units: percent volume/volume
        arithmetic mean (standard deviation)
    7.9 ( 1.5 )
    7.9 ( 1.5 )
    Statistical analysis title
    		 non-parametric Wilcoxon rank-sum test
    Statistical analysis description
    Significance within each group (cell therapy, control group) was assessed by the Kolmogorov-Smirnov test followed by a one-sample t-test with “no change” (Δ=0) as the hypothetical value. Significance of ΔEF between the groups was analysed by the non-parametric Wilcoxon rank-sum test.
    Comparison groups
    cell therapy arm v control group
    Number of subjects included in analysis
    23
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    During visit after 6 and 12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ClinicalTrials.gov
    Dictionary version
    PRS
    Reporting groups
    Reporting group title
    cell therapy group
    Reporting group description
    		 Group of patients receiving cell therapy

    Serious adverse events
    		 cell therapy group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    decompensated heart failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PCI
    Additional description: percutaneous coronary intervention 8 months after cell therapy
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 cell therapy group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    Cardiac disorders
    non-serious cardiac adverse event
    Additional description: non-serious cardiac adverse events: ventricular tachycardia (unrelated/unlikely) occurred in 3 patients
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3

    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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