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    Clinical Trial Results:
    Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE

    Summary
    EudraCT number
    		 2015-002929-19
    Trial protocol
    		 NL   DK   SI   DE   AT   PL  
    Global end of trial date
    31 Dec 2022

    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)
    		 Synopsis SCIENCE
    SCIENCE trial

    Trial information

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    Trial identification
    Sponsor protocol code
    SCIENCE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02673164
    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 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2022
    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
    In hospital follow-up 24 hours after treatment.
    Background therapy
    		 Maximal tolarable medical heart failure therapy
    Evidence for comparator
    		 No
    Actual start date of recruitment
    01 Jan 2016
    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
    Poland: 20
    Country: Number of subjects enrolled
    Slovenia: 30
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Netherlands: 14
    Worldwide total number of subjects
    133
    EEA total number of subjects
    133
    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)
    58
    From 65 to 84 years
    75
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 133 of the planned 139 patients were included in the trial. It was not possible to prolong the inclusion period, due to finalization of the Horizon2020 grant period.

    Pre-assignment
    Screening details
    		 A total of 133 patients (122 men and 11 women) with stable symptomatic chronic ischemic HFrEF were included into the study. Approximately 2/3 of the patients were in NYHA II class and 1/3 in NYHA III in both groups.

    Pre-assignment period milestones
    Number of subjects started
    		 133
    Number of subjects completed
    		 133

    Period 1
    Period 1 title
    Baseline ASC (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All participating in the clinical contact with the patients and the collected data were blinded. When all data were collected and analyzed then the code was broken by the producer of the cell and placebo vials.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ASC treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSCC_ASC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Injections of 110 mio. CSCC_ASCs in 5 mL CryoStor

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Injections of saline

    Number of subjects in period 1
    		ASC treatment Placebo
    Started
    90
    43
    Completed
    90
    41
    Not completed
    0
    2
         dead
    -
    2

    Baseline characteristics

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

    Reporting group values
    		 Baseline ASC Total
    Number of subjects
    		 133 133
    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
    The mean age was 66.4 ± 8.1 years in the ASC group and 64.0 ± 8.8 years in the placebo group
    Units: years
        arithmetic mean (standard deviation)
    		 65.2 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 122 122

    End points

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    End points reporting groups
    Reporting group title
    ASC treatment
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: LVESV (left ventricular end systolic volume)

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    End point title
    		 LVESV (left ventricular end systolic volume)
    End point description
    End point type
    Primary
    End point timeframe
    6 months after ASC or placebo intramyocardial injections
    End point values
    		 ASC treatment Placebo
    Number of subjects analysed
    90
    41
    Units: mL
        number (not applicable)
    90
    41
    Statistical analysis title
    		 T-test
    Comparison groups
    ASC treatment v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months after ASC/placebo treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 other
    Dictionary version
    1
    Reporting groups
    Reporting group title
    ASC and Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 ASC and Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 133 (3.76%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    1 year
         subjects affected / exposed
    5 / 133 (3.76%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ASC and Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 133 (48.87%)
    Cardiac disorders
    1 year
         subjects affected / exposed
    65 / 133 (48.87%)
         occurrences all number
    65

    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/36644821
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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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