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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’. Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with acute myocardial infarction (AMI).

    Summary
    EudraCT number
    		 2016-004662-25
    Trial protocol
    		 PL  
    Global end of trial date
    16 Feb 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
    AMI-Study
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03404063
    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
    Clinical Trial Information Desk, Ewa Gąsior, 48 126142000, e.gasior@szpitaljp2.krakow.pl
    Scientific contact
    Principal Investigator, Piotr Musiałek MD, PhD, 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
    25 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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’. Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with acute myocardial infarction (AMI).
    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. In order to constitute evidence with respect to product safety, regulatory and legal compliance, the investigator agrees to retain project related documents in a location which is secure and to which access can be gained if required. The following documents must be archived: the investigators file with respect to all required GCP documents, including signed patient informed consent forms, CRFs and monitoring forms. Data reported into eCRF will be anonymized by patients code. The list with assigned code numbers will be stored in Investigation Centre and will not be shared. 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
    20 Oct 2017
    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)
    78
    From 65 to 84 years
    37
    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
    CardioCell
    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.

    Number of subjects in period 1 [1]
    		active group placebo
    Started
    70
    35
    Completed
    67
    33
    Not completed
    3
    2
         Adverse event, serious fatal
    2
    2
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 10 patients were enrolled as a pilot cohort according to protocol

    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
    		 -

    Primary: IS of the LV muscle (cMRI) change1

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    End point title
    		 IS of the LV muscle (cMRI) change1
    End point description
    IS (infarct size) of the LV (left ventricle) muscle (cMRI) change between baseline and 6 months FU
    End point type
    Primary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    58
    29
    Units: percent
        median (inter-quartile range (Q1-Q3))
    -6.36 (-11.46 to -2.41)
    -9.54 (-19.93 to -4.74)
    Statistical analysis title
    		 IS of the LV muscle (cMRI) change
    Comparison groups
    placebo v active group
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0171
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IS of the LV muscle (SPECT) change

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    End point title
    		 IS of the LV muscle (SPECT) change
    End point description
    IS of the LV muscle (SPECT) change
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    68
    33
    Units: number
        median (inter-quartile range (Q1-Q3))
    -1.0 (-6.0 to 2.0)
    -1.0 (-9.50 to 3.00)
    Statistical analysis title
    		 IS of the LV muscle (SPECT) change
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6478
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LVEF (cMRI) change

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    End point title
    		 LVEF (cMRI) change
    End point description
    LVEF- left ventricle ejection fraction (cMRI- cardiac magnetic resonance ) change between baseline and 6 months FU
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    63
    31
    Units: number
        median (inter-quartile range (Q1-Q3))
    4.00 (-1.00 to 11.00)
    6.00 (3.00 to 9.00)
    Statistical analysis title
    		 LVEF (cMRI) change
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3319
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LVEF (SPECT) change

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    End point title
    		 LVEF (SPECT) change
    End point description
    LVEF (left ventricle ejection fraction) (SPECT) change between baseline and 6 months FU
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    69
    33
    Units: number
        median (inter-quartile range (Q1-Q3))
    3.00 (-2.00 to 7.00)
    3.00 (-0.50 to 7.00)
    Statistical analysis title
    		 LVEF (SPECT) change
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3965
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: LVEF (echo) change

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    End point title
    		 LVEF (echo) change
    End point description
    LVEF- left ventricle ejection fraction (echo) change between baseline and 6 months FU
    End point type
    Secondary
    End point timeframe
    baseline vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    68
    33
    Units: number
        median (inter-quartile range (Q1-Q3))
    3.50 (0.25 to 8.00)
    7.00 (1.50 to 10.00)
    Statistical analysis title
    		 LVEF (echo) change
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2067
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Death, MI and/or hospitalization for HF - up to 365 days after procedure

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    End point title
    		 Death, MI and/or hospitalization for HF - up to 365 days after procedure
    End point description
    Death, MI (myocardial infarct) and/or hospitalization for HF - up to 365 days after procedure
    End point type
    Secondary
    End point timeframe
    baselien vs 6 months FU
    End point values
    		 active group placebo
    Number of subjects analysed
    70
    35
    Units: number
    5
    5
    Statistical analysis title
    		 Death, MI and/or hospitalization for HF during obs
    Comparison groups
    active group v placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2953
    Method
    		 Fisher exact
    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
    overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 105 (20.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    5
    Investigations
    Cardiac stress test abnormal
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Critical limb ischaemia
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiac failure
    Additional description: cardiac failure aggravated
         subjects affected / exposed
    7 / 105 (6.67%)
         occurrences causally related to treatment / all
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Coronary artery disease progression
    Additional description: Coronary artery disease progression
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    ventricular arrhythmia
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    unstable angina
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Ischemic stroke
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Transient ischemic attack
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal bleeding
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    1 / 105 (0.95%)
         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
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 105 (55.24%)
    Cardiac disorders
    ICD implantation
         subjects affected / exposed
    11 / 105 (10.48%)
         occurrences all number
    11
    planned PCI
    Additional description: planned PCI performed prior to study procedure
         subjects affected / exposed
    17 / 105 (16.19%)
         occurrences all number
    17
    planned carotid artery stenting
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    3
    left ventricle thrombus
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    3
    mil arrythmia
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    chest pain
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    4
    control angiography
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    heart failure optimalisation
         subjects affected / exposed
    4 / 105 (3.81%)
         occurrences all number
    4
    hypotonia and fainting
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    pericardial effusion
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    poor blood pressure control
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Gastrointestinal disorders
    cholelithiasis causing bilious colic
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    diarrhoea
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    pneumonia
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    rash
    Additional description: rash after procedure
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    3
    Epistaxis
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    hematoma on thigh
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    3 / 105 (2.86%)
         occurrences all number
    3
    vaginal bleeding
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    urinary retention
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Nephropathy
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Renal colic
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Endocrine disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 105 (1.90%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Chills
    Additional description: chills after study procedure
         subjects affected / exposed
    7 / 105 (6.67%)
         occurrences all number
    7
    Fracture of left fibula
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences all number
    1
    Infections and infestations
    mild/moderate infection
         subjects affected / exposed
    4 / 105 (3.81%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2017
    Version 2.0 - following the decision to split CIRCULATE project into three separate clinical trials a version of the protocol was prepared in which the investigated medical condition was acute myocardial infarction (AMI).
    12 Feb 2019
    Version 3.0- 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
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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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