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    Clinical Trial Results:
    Allogeneic adipose tissue-derived stromal/stem cell therapy in patients with ischemic heart disease and heart failure

    Summary
    EudraCT number
    		 2015-001560-19
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2023
    First version publication date
    19 May 2023
    Other versions
    Summary report(s)
    		 ASC_HF II

    Trial information

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    Trial identification
    Sponsor protocol code
    CSCC-ASC2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02387723
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej, Copenhagen, Denmark, 2100
    Public contact
    Jens Kastrup, Department of Cardiology, 2014, Rigshospitalet, 0045 35452819, jens.kastrup@regionh.dk
    Scientific contact
    Jens Kastrup, Department of Cardiology, 2014, Rigshospitalet, 0045 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
    01 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To perform at clinical double-blind placebo-controlled CSCC_ASC multicentre study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.
    Protection of trial subjects
    Patients are hospitalized 24 hours after treatment
    Background therapy
    		 Maximal tolerable heart failure medical therapy
    Evidence for comparator
    		 No
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    39
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The planned 81 patients were enrolled in the study. 54 patients were treated with cell product and 27 with placebo. Mean age was 67.0 ± 9.0 years and 66.6 ± 8.1 years in the ASC and placebo groups, respectively.

    Pre-assignment
    Screening details
    		 Patients had to meet the predefined in- and exclusion criteria. 139 patients were screeened. 49 did not meet the inclusion criteria. 1 had severe kidney disease, 2 had infection, 2 had severe claudicatio, 1 had mural thrombus and 3 withdrew consent

    Pre-assignment period milestones
    Number of subjects started
    		 81
    Number of subjects completed
    		 81

    Period 1
    Period 1 title
    Randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Assessor, Data analyst, Subject
    Blinding implementation details
    All image data was stored on a central server and analysed blinded by two independent observers not aware of the treatment allocation. Moreover, they did not have access to each other’s analysed images. The study nurses, physicians and patients were not aware of the treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ASC treatment
    Arm description
    		 Injections of 0.3 mL CSCC_ASC (total cell dose 100 x 106 ASCs) (n=54) performed into the viable myocardium in the border zone of infarcted tissue using the NOGA Myostar® catheter (Biological Delivery System, Cordis, Johnson & Johnson, US).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allogeneic adipose tissue-derived stromal cells. (CSCC_ASC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CSCC_ASC constituted 110 million ASCs/5 mL CryoStor CS10 (BioLife Solutions). The CSCC_ASCs were injected into the myocardium by 12-15 injections of 0.3 mL solution except the first injection, which consisted of 0.4 mL. Point by point measurement generates an electromechanical 3D LV map. The system distinguishes between viable (unipolar voltage > 12 mV, bipolar voltage > 2.5 mV, local linear shortening-LLS > 6 %), non-viable-myocardium (unipolar voltage < 6 mV, bipolar voltage < 1.5 mV, LLS < 4%) and border zone (unipolar voltage 6-12 mV, bipolar voltage 1.5-2.5 mV, LLS 4-6 %) around myocardial scar tissue. To ensure appropriate injection into the ventricle wall, the injection catheter tip was located perpendicular to the ventricle wall and a ventricular extrasystole was elicited when extending the needle into the wall before any injection. The injections were performed into the viable myocardium judged by the 3D map in the border zone of infarcted tissue tissue with a unipo

    Arm title
    		 Placebo
    Arm description
    		 Injections of 0.3 mL isotonic saline (n=27) were performed into the viable myocardium in the border zone of infarcted tissue using the NOGA Myostar® catheter (Biological Delivery System, Cordis, Johnson & Johnson, US).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The placebo was injected into the myocardium by 12-15 injections of 0.3 mL solution except the first injection, which consisted of 0.4 mL. Point by point measurement generates an electromechanical 3D LV map. The system distinguishes between viable (unipolar voltage > 12 mV, bipolar voltage > 2.5 mV, local linear shortening-LLS > 6 %), non-viable-myocardium (unipolar voltage < 6 mV, bipolar voltage < 1.5 mV, LLS < 4%) and border zone (unipolar voltage 6-12 mV, bipolar voltage 1.5-2.5 mV, LLS 4-6 %) around myocardial scar tissue. To ensure appropriate injection into the ventricle wall, the injection catheter tip was located perpendicular to the ventricle wall and a ventricular extrasystole was elicited when extending the needle into the wall before any injection. The injections were performed into the viable myocardium judged by the 3D map in the border zone of infarcted tissue tissue with a unipolar voltage > 6 mV.

    Number of subjects in period 1
    		ASC treatment Placebo
    Started
    54
    27
    Completed
    52
    27
    Not completed
    2
    0
         Dead
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 81 81
    Age categorical
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    67.0 ± 9.0 years in the ASC group and 66.6 ± 8.1 years in the placebo group
    Units: years
        arithmetic mean (standard deviation)
    		 66.8 ( 8.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 68 68

    End points

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    End points reporting groups
    Reporting group title
    ASC treatment
    Reporting group description
    		 Injections of 0.3 mL CSCC_ASC (total cell dose 100 x 106 ASCs) (n=54) performed into the viable myocardium in the border zone of infarcted tissue using the NOGA Myostar® catheter (Biological Delivery System, Cordis, Johnson & Johnson, US).

    Reporting group title
    Placebo
    Reporting group description
    		 Injections of 0.3 mL isotonic saline (n=27) were performed into the viable myocardium in the border zone of infarcted tissue using the NOGA Myostar® catheter (Biological Delivery System, Cordis, Johnson & Johnson, US).

    Primary: LVESV (left ventricular end systolic volume)

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    End point title
    		 LVESV (left ventricular end systolic volume)
    End point description
    Difference between the two groups
    End point type
    Primary
    End point timeframe
    6 months after ASC/placebo injections
    End point values
    		 ASC treatment Placebo
    Number of subjects analysed
    52
    27
    Units: mL
        number (not applicable)
    52
    27
    Statistical analysis title
    		 T-test
    Statistical analysis description
    Paired t-test was used for normal distributed continuous data comparison within groups and unpaired t-test was used for comparison between groups
    Comparison groups
    ASC treatment v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 9
    Variability estimate
    Standard deviation
    Notes
    [1] - Between the two grops

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 years followup
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Adverse events
    Dictionary version
    1
    Reporting groups
    Reporting group title
    ASC and placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 ASC and placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 81 (3.70%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    1 year
         subjects affected / exposed
    3 / 81 (3.70%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ASC and placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 81 (39.51%)
    Cardiac disorders
    1 year
         subjects affected / exposed
    32 / 81 (39.51%)
         occurrences all number
    32

    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/36638837
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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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