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    Clinical Trial Results:
    Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine. Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’ Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in patients with Chronic Ischaemic Heart Failure (CIHF)

    Summary
    EudraCT number
    		 2016-004683-19
    Trial protocol
    		 PL  
    Global end of trial date
    10 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2022
    First version publication date
    14 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIHF-Study
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03418233
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Krakowski Szpital Specjalistyczny im. Jana Pawła II
    Sponsor organisation address
    Pradnicka 80, Krakow, Poland, 31-202
    Public contact
    Gąsior, Ewa, 48 126142000, e.gasior@szpitaljp2.krakow.pl
    Scientific contact
    MD, PhD, Piotr Musiałek, 48 126142000, badaniakliniczne@szpitaljp2.krakow.pl
    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
    30 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the regenerative capacity of CardioCell in patients with Chronic Ischaemic Heart Failure (CIHF) based on the evaluation of Left ventricle ejection fraction assessed by SPECT
    Protection of trial subjects
    The Principal Investigator (PI) retains overall responsibility for the informed consent of participants at their site and must ensure that any person delegated responsibility to participate in the informed consent process is duly authorized, trained and competent to participate according to the ethically approved protocol, principles of Good Clinical Practice (GCP) and Declaration of Helsinki. The Sponsor has ethical, legal and scientific obligations to carefully follow this project in a detailed and orderly manner in accordance with established research principles and applicable regulations. The investigator, as part of his responsibilities, is expected to cooperate with the Sponsor in ensuring that the project adheres to the protocol and GCP requirements. As part of a concerted effort to fulfil these obligations, the Sponsor will authorize a Clinical research Organization (CRO) to perform monitoring tasks and visit the centers during the project. The processes reviewed can relate to participant enrolment, consent, eligibility, and allocation to trial groups; adherence to trial interventions and policies to protect participants, including reporting of harm and completeness, accuracy, and timeliness of data collection. The investigator will permit the Sponsor’ authorized CRO personnel to monitor the project as frequently as is deemed necessary and provide access to medical records.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 May 2018
    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: 115
    Worldwide total number of subjects
    115
    EEA total number of subjects
    115
    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
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients who provided informed consent and met inclusion criteria without any exclusion criteria were enrolled to the study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cardio-Cell
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intracoronary use
    Dosage and administration details
    Patients randomized to the active treatment group: Transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin) was performed using a dedicated cell delivery catheter.

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Cardio-Cell placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracoronary use
    Dosage and administration details
    Patients randomized to the placebo group: 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.

    Arm title
    		 labelled cardio-cell
    Arm description
    		 active labelled product, not blinded, according to protocol
    Arm type
    		 active labelled product

    Investigational medicinal product name
    labeled Cardio-Cell
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intracoronary use
    Dosage and administration details
    Patients randomized to the active labeled product treatment group: Transcoronary or trans-bypass graft administration of labeled Cardo-Cell at dosage of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin) will be performed using a dedicated cell delivery catheter.

    Number of subjects in period 1
    		active group placebo labelled cardio-cell
    Started
    69
    36
    10
    Completed
    63
    34
    10
    Not completed
    6
    2
    0
         Adverse event, serious fatal
    4
    1
    -
         Consent withdrawn by subject
    1
    -
    -
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    active group
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    labelled cardio-cell
    Reporting group description
    		 active labelled product, not blinded, according to protocol

    Primary: Left ventricle ejection fraction (LVEF) increase

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    End point title
    		 Left ventricle ejection fraction (LVEF) increase
    End point description
    Left ventricle ejection fraction (LVEF) increase, assessed by SPECT at 6M FU vs. during index (baseline) imaging – comparison between two groups (active vs placebo therapy)
    End point type
    Primary
    End point timeframe
    baseline vs 6 M FU
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    61
    27
    8
    Units: percent
        median (inter-quartile range (Q1-Q3))
    1.0 (-1.0 to 4.0)
    3.0 (-1.0 to 5.0)
    -2.0 (-5.75 to -0.25)
    Statistical analysis title
    		 Left ventricle ejection fraction (LVEF) increase
    Comparison groups
    placebo v active group
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.912
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: An increase the result of 6 minute walk test at 3 and 6 month.

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    End point title
    		 An increase the result of 6 minute walk test at 3 and 6 month.
    End point description
    total distance difference in 6 minute walk test between baseline and 6 month.
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU- total distance difference
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    44
    29
    7
    Units: metre
        median (inter-quartile range (Q1-Q3))
    35.5 (5.0 to 76.0)
    25.0 (0.0 to 76.5)
    55.0 (15.0 to 60.0)
    Statistical analysis title
    		 An increase the result of 6 minute walk test
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7097
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU.

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    End point title
    		 Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU.
    End point description
    Difference between IS (infarct scar) [%left ventricle] in MRI at 6m FU and baseline
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    26
    13
    0 [1]
    Units: percent
        median (inter-quartile range (Q1-Q3))
    -0.52 (-0.91 to -0.26)
    -0.62 (-1.06 to -0.18)
    ( to )
    Notes
    [1] - endpoint in this population was not analysed according to protocol (labelled population)
    Statistical analysis title
    		 Myocardial perfusion improvement MR
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9694
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: An improvement the result of spiroergometric test at 6 month FU.

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    End point title
    		 An improvement the result of spiroergometric test at 6 month FU.
    End point description
    An improvement the result of spiroergometric test at 6 month FU - VO₂max (mL/(kg∙min)) difference
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    22
    14
    4
    Units: varied
        median (inter-quartile range (Q1-Q3))
    1.75 (0.3 to 3.2)
    -0.2 (-2.88 to 1.83)
    2.95 (-2.3 to 7.6)
    Statistical analysis title
    		 An improvement the result of spiroergometric test
    Statistical analysis description
    An improvement the result of spiroergometric test at 6 month FU.
    Comparison groups
    placebo v active group
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1761
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: echocardiography LVEF, EDV, ESV assesment

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    End point title
    		 echocardiography LVEF, EDV, ESV assesment
    End point description
    Left ventricle ejection fraction (LVEF) change against baseline, assessed in echocardiography at 6 months FU.
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    65
    35
    9
    Units: varied
        median (inter-quartile range (Q1-Q3))
    2.0 (-1.0 to 4.0)
    3.0 (1.0 to 5.0)
    1.0 (-1.0 to 3.5)
    Statistical analysis title
    		 echocardiography LVEF
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1378
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: NT pro-BNP level a 6 months in comparison to the baseline level.

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    End point title
    		 NT pro-BNP level a 6 months in comparison to the baseline level.
    End point description
    NT pro-BNP level at 6 months in comparison to the baseline level
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    61
    34
    10
    Units: pg/ml
        median (inter-quartile range (Q1-Q3))
    39 (-128.5 to 315.50)
    -24.5 (-447.75 to 204.0)
    -280.0 (-554.50 to 95.75)
    Statistical analysis title
    		 NT pro-BNP level a 6 months in comparison
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0619
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 6 month and 1 year FU.

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    End point title
    		 The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 6 month and 1 year FU.
    End point description
    The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 1 year FU
    End point type
    Secondary
    End point timeframe
    baseline vs 1 year FU
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    69
    36
    10
    Units: amount (n)
    12
    2
    2
    Statistical analysis title
    		 The occurrence of MACE
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1312
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU.

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    End point title
    		 Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU.
    End point description
    Physical functioning: Baseline - 6M FU
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months vs 1 year FU
    End point values
    		 active group placebo labelled cardio-cell
    Number of subjects analysed
    60
    32
    8
    Units: number
        median (inter-quartile range (Q1-Q3))
    5.0 (-5.0 to 10)
    5.0 (0.0 to 18.75)
    2.5 (-17.5 to 15.0)
    Statistical analysis title
    		 Quality of life improvement
    Comparison groups
    placebo v active group
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1998
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported in patients from personal consent and study enrollment to last visit in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    trial population
    Reporting group description
    		 -

    Serious adverse events
    		 trial population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 115 (25.22%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    heart failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 115 (13.04%)
         occurrences causally related to treatment / all
    0 / 21
         deaths causally related to treatment / all
    0 / 1
    Acute myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    coronary artery disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 115 (2.61%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    cardiac thrombus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    LVAD implantation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
    Additional description: no additional information from family was available
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Peritonitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin and subcutaneous tissue disorders
    necrotic ulceration of foot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin lesion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    kidney failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    medical device site infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 115 (1.74%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 trial population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 115 (18.26%)
    Vascular disorders
    haemoptysis
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    Cardiac disorders
    PCI
    Additional description: PCI prior to procedure during control angiography
         subjects affected / exposed
    5 / 115 (4.35%)
         occurrences all number
    5
    ICD implantation/reimplantation
         subjects affected / exposed
    5 / 115 (4.35%)
         occurrences all number
    5
    heart failure optimalisation
         subjects affected / exposed
    4 / 115 (3.48%)
         occurrences all number
    5
    CRT implantation
         subjects affected / exposed
    2 / 115 (1.74%)
         occurrences all number
    2
    chest pain
         subjects affected / exposed
    3 / 115 (2.61%)
         occurrences all number
    3
    transient no-reflow
    Additional description: Transient no-reflow in the right coronary artery during administration of the study product.
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    Surgical and medical procedures
    planned operation
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    visit in emergency unit
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    Nervous system disorders
    mild stroke
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma exacerbation
         subjects affected / exposed
    1 / 115 (0.87%)
         occurrences all number
    2
    Infections and infestations
    mild infection
         subjects affected / exposed
    2 / 115 (1.74%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2019
    Version 2.0- data of new study sites was added, description of study catheter was clarified, information about additional blood collections was added.

    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
    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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