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    Clinical Trial Results:
    A prospective, double blind, randomized, placebo-controlled clinical trial of intracoronary infusion of immunoselected, bone marrow-derived Stro3 mesenchymal precursor cells (MPC) in the treatment of patients with ST-elevation myocardial infarction

    Summary
    EudraCT number
    2010-020497-41
    Trial protocol
    GB   BE   NL   DK   SE   CZ   AT   PL   IT   ES   PT  
    Global end of trial date
    06 Apr 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Feb 2023
    First version publication date
    25 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANG.AMI-IC001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01781390
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Mesoblast, Inc.
    Sponsor organisation address
    5 New Street Square, London, United Kingdom, EC4A 3TW
    Public contact
    Clinical Trials Information, Mesoblast Limited , +61 396396036, clinical@mesoblast.com
    Scientific contact
    Clinical Trials Information, Mesoblast Limited , +61 396396036, clinical@mesoblast.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
    06 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the safety and feasibility of intracoronary allogeneic, immuno-selected, bone marrow-derived Stro3 mesenchymal precursor cell (MPC) delivery in the treatment of subjects with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention of the left anterior descending coronary artery (LAD).
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP). In addition, the study was overseen by an Independent Data and Safety Monitoring Board.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 25
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Czechia: 19
    Country: Number of subjects enrolled
    Denmark: 5
    Worldwide total number of subjects
    103
    EEA total number of subjects
    80
    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)
    66
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects with a diagnosis of ST-elevation myocardial infarction were randomized in 1:1:1 to receive either 12.5 Million or 25 Million MPCs or placebo (saline).

    Pre-assignment period milestones
    Number of subjects started
    106 [1]
    Number of subjects completed
    103

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Subjects who were Randomized and Not Treated: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 106 subjects were randomized in the study out of which 3 subjects were not treated.
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received matching-placebo solution 2 milliliters per minute (mL/min) infused intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracoronary use
    Dosage and administration details
    Matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary.

    Arm title
    Mesenchymal Precursor Cells (MPC) 12.5 M
    Arm description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Mesenchymal Precursor Cells (MPC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracoronary use
    Dosage and administration details
    MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min

    Arm title
    Mesenchymal Precursor Cells (MPC) 25 M
    Arm description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Mesenchymal Precursor Cells (MPC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracoronary use
    Dosage and administration details
    MPC 25 solution 2 mL/min infused Intracoronary for 60 min

    Number of subjects in period 1
    Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
    Started
    34
    34
    35
    Completed
    32
    28
    32
    Not completed
    2
    6
    3
         Withdrawal of Consent
    -
    3
    1
         Adverse Event
    1
    2
    1
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching-placebo solution 2 milliliters per minute (mL/min) infused intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 12.5 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 25 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.

    Reporting group values
    Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M Total
    Number of subjects
    34 34 35 103
    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
    Units: years
        arithmetic mean (standard deviation)
    61.3 ± 9.79 60.7 ± 13.11 57.6 ± 12.12 -
    Gender categorical
    Units: Subjects
        Female
    7 2 8 17
        Male
    27 32 27 86
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1 1 0 2
        Not Hispanic or Latino
    33 33 35 101
        Unknown or Not Reported
    0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    1 0 0 1
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    0 0 0 0
        White
    33 33 34 100
        More than one race
    0 0 0 0
        Unknown or Not Reported
    0 1 1 2
    Left Ventricular (LV) End-systolic Volume (LVESV) as Assessed by Cardiac MRI
    Full analysis population included all subjects who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of subjects with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
    Units: milliliter (ml)
        arithmetic mean (standard deviation)
    85.544 ± 34.8935 91.728 ± 30.4476 92.163 ± 33.1251 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching-placebo solution 2 milliliters per minute (mL/min) infused intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 12.5 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 25 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.

    Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [1]
    End point description
    The safety set included all randomized subjects who received treatment.
    End point type
    Primary
    End point timeframe
    Up to approximately 8 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was conducted for this endpoint.
    End point values
    Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
    Number of subjects analysed
    34
    34
    35
    Units: subjects
        TEAEs
    28
    30
    31
        SAEs
    14
    16
    14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 8 years
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching-placebo solution 2 milliliters per minute (mL/min) infused intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 12.5 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.

    Reporting group title
    Mesenchymal Precursor Cells (MPC) 25 M
    Reporting group description
    Subjects received MPC 12.5 solution 2 mL/min infused intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.

    Serious adverse events
    Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 34 (41.18%)
    16 / 34 (47.06%)
    14 / 35 (40.00%)
         number of deaths (all causes)
    0
    2
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Thyroid adenoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    3 / 35 (8.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Angina pectoris
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diaphragmatic hernia gangrenous
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypovolaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 34 (76.47%)
    30 / 34 (88.24%)
    30 / 35 (85.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    3 / 35 (8.57%)
         occurrences all number
    2
    1
    3
    Hypotension
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 34 (11.76%)
    1 / 35 (2.86%)
         occurrences all number
    2
    4
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 34 (11.76%)
    1 / 35 (2.86%)
         occurrences all number
    1
    5
    1
    Aortic dilatation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Catheter site haematoma
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    1
    2
    1
    Chest pain
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    3 / 35 (8.57%)
         occurrences all number
    1
    1
    4
    Fatigue
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
         occurrences all number
    3
    5
    1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 34 (5.88%)
    6 / 34 (17.65%)
    3 / 35 (8.57%)
         occurrences all number
    2
    7
    4
    Oedema peripheral
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    2
    Pyrexia
         subjects affected / exposed
    5 / 34 (14.71%)
    2 / 34 (5.88%)
    3 / 35 (8.57%)
         occurrences all number
    5
    2
    3
    Chest discomfort
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Medical device site rash
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Pseudophakodonesis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    2
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Rales
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    0
    Cough
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
    5 / 35 (14.29%)
         occurrences all number
    3
    2
    5
    Dyspnoea
         subjects affected / exposed
    2 / 34 (5.88%)
    8 / 34 (23.53%)
    2 / 35 (5.71%)
         occurrences all number
    2
    11
    3
    Epistaxis
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    2
    0
    1
    Asthma
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    4
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Pleural effusion
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory failure
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract inflammation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    1
    2
    1
    Insomnia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    1
    1
    2
    Claustrophobia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Initial insomnia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Cardiac murmur
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Electrocardiogram T wave normal
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Gastric pH decreased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Heart rate irregular
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Inflammatory marker increased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Monoclonal immunoglobulin present
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin B12 decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Post procedural haematoma
         subjects affected / exposed
    4 / 34 (11.76%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    0
    Arthropod sting
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Radius fracture
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Wound
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
         occurrences all number
    3
    3
    1
    Arteriospasm coronary
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    Bradycardia
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    3
    Cardiac failure
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    3 / 35 (8.57%)
         occurrences all number
    1
    1
    3
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 34 (11.76%)
    0 / 35 (0.00%)
         occurrences all number
    1
    4
    0
    Palpitations
         subjects affected / exposed
    0 / 34 (0.00%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
         occurrences all number
    0
    4
    1
    Pericarditis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    3 / 35 (8.57%)
         occurrences all number
    0
    1
    3
    Ventricular tachycardia
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 34 (8.82%)
    5 / 35 (14.29%)
         occurrences all number
    1
    7
    5
    Atrial flutter
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Intracardiac thrombus
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Arrhythmia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Cardiac aneurysm
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Chronotropic incompetence
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Coronary artery dissection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Dressler's syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Pericardial rub
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Rhythm idioventricular
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 34 (11.76%)
    8 / 34 (23.53%)
    5 / 35 (14.29%)
         occurrences all number
    5
    12
    5
    Dizziness postural
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    Headache
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    2
    1
    2
    Lethargy
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
         occurrences all number
    1
    3
    1
    Presyncope
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Syncope
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Amnesia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Mental impairment
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Sensory disturbance
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    2
    2
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Spontaneous haematoma
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Cataract
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Macular degeneration
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    2
    Constipation
         subjects affected / exposed
    1 / 34 (2.94%)
    5 / 34 (14.71%)
    1 / 35 (2.86%)
         occurrences all number
    1
    5
    1
    Diarrhoea
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 34 (8.82%)
    5 / 35 (14.29%)
         occurrences all number
    4
    3
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    0
    4
    0
    Nausea
         subjects affected / exposed
    1 / 34 (2.94%)
    5 / 34 (14.71%)
    3 / 35 (8.57%)
         occurrences all number
    1
    5
    4
    Vomiting
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
    3 / 35 (8.57%)
         occurrences all number
    3
    2
    3
    Dyspepsia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal hernia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Bowel movement irregularity
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Chronic gastritis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Eructation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal spasm
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic failure
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Liver disorder
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    3 / 35 (8.57%)
         occurrences all number
    0
    0
    3
    Lower urinary tract symptoms
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Urinary retention
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Renal cyst
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Renal failure
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Strangury
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Ureterolithiasis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    4 / 35 (11.43%)
         occurrences all number
    0
    1
    5
    Muscle spasms
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    3
    Musculoskeletal pain
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 34 (11.76%)
    1 / 35 (2.86%)
         occurrences all number
    1
    4
    1
    Myalgia
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    2
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    4
    Arthralgia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    1
    Costochondritis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    2
    Tendonitis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    3 / 35 (8.57%)
         occurrences all number
    0
    3
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    3
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    0
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 34 (8.82%)
    0 / 35 (0.00%)
         occurrences all number
    1
    4
    0
    Bronchitis
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Campylobacter infection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Corona virus infection
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Eye infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Lung infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Pertussis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    1
    Decreased appetite
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Gout
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2012
    The purpose of the amendment was to refine assessments, include additional events captured as Major adverse cardiac and cerebrovascular events(MACCE) to be consistent with the CEC adjudication process, clarification of AE description of the Severity and changing Causality to a binary assessment. Clarification on feasibility endpoint was also made.
    24 Apr 2012
    The purpose of the amendment was to remove termination conditions outlined in section 4.4, early termination of study and in Section 12.8 termination of study.
    21 May 2012
    The purpose of the amendment was to revise wording with respect to early termination of the study.
    07 Sep 2012
    The purpose of the amendment was to refine timing and type of assessments, including ECHO, ECG, Troponins, Serum Pregnancy Test, and AEs. Added footnotes to Table 2. Replaced conditions for conducting cardiac MRI at Early Termination Visit. Updated data on Human Clinical Studies. Clarified infusion time of allogeneic MPCs. Revised the frequency of providing adverse event and serious adverse event data to the DSMB. Clarified the protocol assessments and follow-up for subjects who prematurely withdrew from study. Added non-MACCE events that may be reviewed by Clinical Events Committee.
    06 Aug 2013
    The purpose of the amendment was to refine assessments, inclusion / exclusion criteria, modify solution for dilution of the MPCs and placebo. Included requirement of an intracoronary bolus of glyceryl trinitrate (GTN)/ nitroglycerin (NTG) administration prior to the initial infusion of the investigational agent. Changed primary efficacy endpoint.
    13 May 2014
    The purpose of the amendment was to add study hypothesis, and revise study assessments, secondary objectives, and primary efficacy endpoint. Timing of Onset of Chest Pain to Initial Balloon Inflation and stratification for randomization balancing was revised. Updated statistical analysis methods for the primary analysis.
    01 Aug 2016
    The purpose of the amendment was to update the rationale for trial size and justification that an interim analysis was not needed and was not to be performed.
    11 Oct 2016
    The purpose of the amendment was to correct the power from 90% to 80%.
    04 May 2017
    The purpose of the amendment was to correct power from 90% to 80%. A power of 90% was inadvertently introduced when addressing the assumptions for changing the sample size from 225 to 105 (Protocol v8).

    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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