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    Clinical Trial Results:
    Evaluation of the safety and efficacy of the treatment of scars and cutis laxa syndrome with the use of autologous (fresh and stored) stem cells isolated from adipose tissue within the project: 'The therapeutic potential of mesenchymal stem cells tested in clinical trials and in vitro - a justification for characterized cells storage'.

    Summary
    EudraCT number
    		 2016-004110-10
    Trial protocol
    		 PL  
    Global end of trial date
    18 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2021
    First version publication date
    24 Jun 2021
    Other versions
    Summary report(s)
    		 SUMMARY_2ABC_clinical_trial

    Trial information

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    Trial identification
    Sponsor protocol code
    2ABC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03887208
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Warsaw
    Sponsor organisation address
    ul. Żwirki i Wigury 61, Warszawa, Poland, 02-091
    Public contact
    malgorzata.lewandowska-szumiel@wum.edu.pl, Center for Preclinical Research and Technology CEPT, 4822 1166115, malgorzata.lewandowska-szumiel@wum.edu.pl
    Scientific contact
    malgorzata.lewandowska-szumiel@wum.edu.pl, Center for Preclinical Research and Technology CEPT, 4822 1166115, malgorzata.lewandowska-szumiel@wum.edu.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
    18 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study was to demonstrate the safety and efficacy of autologous adipose tissue-derived stem cells - fresh (SVF fraction) or cryopreserved (ADSC fraction), delivered via topical injection in patients with scarring or cutis laxa of the dorsal surface of the hands.
    Protection of trial subjects
    The study protocol and all changes to this document and patient information card have been reviewed and approved by the appropriate independent ethics committees. The study was conducted in accordance with the current version of the declaration of Helsinki. The study was conducted in accordance with the Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH). Before the study, all patients gave written informed consent to participate in the study. The study procedures (objectives, methodology, potential risks, anticipated benefits) were detailed in the patient information card and explained to each patient by the investigator. In order to protect patients, the following medications were used: Midazolam - premedication, relieving tension before surgery EMLA (Lidocaine + Prilocaine) - analgesic Tumescent fluid - infiltration anesthesia Augmentin - infection prevention Low molecular weight heparin - antithrombotic prevention
    Background therapy
    		 Before the mesotherapy treatment/placebo administration, all patients underwent a non-ablative fractional laser treatment aimed at stimulating collagen renewal, which is used in the treatment of scars and keloids, smoothing the skin surface and improving skin tone. The laser setting parameters in all patients were the same, in low standard ranges recommended for a given area and type of changes/indications in the patient. Before liposuction, anticoagulant treatment with low molecular weight heparin in a standard dose, oral antibiotic (Augmentin 1.0 g) or intravenous (Tarcefandol 1.0 g - second generation cephalosporin) and premedication (Midazolam 7.5-15 mg) were used. Operation fields were prepared as for a surgical procedure, i.e. washed with a disinfectant. Before the laser therapy and mesotherapy, Emla cream with lignocaine and 5% prilocaine or prescription cream with 23% lignocaine was used (40-60 min). They were washed off before the procedure. Allowed emergency treatment included: - causal treatment of emergency medical conditions directly life-threatening, - systemic antibiotic therapy in the case of bacterial infections up to 10 days, - topical treatment with antiseptics (octenisept, boric acid, chlorhexidine).
    Evidence for comparator
    		 Studied therapy was compared to placebo.
    Actual start date of recruitment
    31 Jan 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: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    99
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient recruitment to the clinical trial started on 31.01.2018. The first patient was enrolled to the study on 31.01.2018 and the last patient on 23.05.2019. Patients were recruited in two research centers: Timeless Chirurgia Plastyczna spółka z o.o., Warsaw, Poland and Melitus Sp. z o o, Warsaw, Poland.

    Pre-assignment
    Screening details
    		 The number of patients planned for inclusion was 100. 127 patients were recruited (signed consent to participate in the study) in two clinical sites: 72 at Site 1 and 55 at Site 2. 15 patients did not pass the screening. 112 patients were randomized - 92 to arm A (active treatment) and 20 to arm B (placebo).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 In arm A patients with cutis laxa or scarring received a dose of stem cell suspension isolated from lipoaspirate and then injected into the patient's skin. Patients received treatment in two schemes. In Scheme I (SVF) patients received a fresh fraction of cells isolated from adipose tissue (not subjected to in vitro culture). This is the so-called stromal vascular fraction. Some SVF cells were frozen and some were prepared in cell culture for the second and subsequent applications in the patient. In Scheme II (ADSC) the first application of the cultured cell suspension took place 6-12 days after the liposuction/lipoaspiration procedure. Some cells were cryopreserved and after thawing prepared in cell culture for the second and subsequent applications in the patient.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adipose tissue-derived mesenchymal stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A dose of stem cell suspension isolated from lipoaspirate and then injected into the patient's skin

    Arm title
    		 Placebo
    Arm description
    		 In arm B, placebo was administered to a hand or two scars or a single scar. The placebo was a 0.9% NaCl (saline) solution injected using the same procedure as for the stem cell suspension.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The placebo was a 0.9% NaCl (saline) solution injected using the same procedure as for the stem cell suspension.

    Number of subjects in period 1
    		Arm A Placebo
    Started
    92
    20
    Completed
    74
    20
    Not completed
    18
    0
         Consent withdrawn by subject
    12
    -
         preparation of product was imposible
    4
    -
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 overall trial (overall period) Total
    Number of subjects
    		 112 112
    Age categorical
    Subjects aged 18-75 years were enrolled in the trial
    Units: Subjects
        Adults (18-75 years)
    		 112 112
    Gender categorical
    Units: Subjects
        Female
    		 103 103
        Male
    		 9 9
    Subject analysis sets

    Subject analysis set title
    All patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis

    Subject analysis set title
    Arm A Scarring SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm A Cutis laxa SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm A Cutis laxa ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm A Scarring ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm B Cutis laxa ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B Scarring ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B Cutis laxa SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm B Scarring SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm A ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm A SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm B ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm A Scarring
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring administered active treatment

    Subject analysis set title
    Arm A Cutis laxa
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment

    Subject analysis set title
    Arm B Scarring
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered placebo

    Subject analysis set title
    Arm B Cutis laxa
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo

    Subject analysis sets values
    		 All patients Arm A Scarring SVF Arm A Cutis laxa SVF Arm A Cutis laxa ADSC Arm A Scarring ADSC Arm B Cutis laxa ADSC Arm B Scarring ADSC Arm B Cutis laxa SVF Arm B Scarring SVF Arm A ADSC Arm A SVF Arm B ADSC Arm B SVF Arm A Scarring Arm A Cutis laxa Arm B Scarring Arm B Cutis laxa
    Number of subjects
    94
    18
    17
    20
    19
    5
    5
    5
    5
    39
    35
    10
    10
    37
    37
    10
    10
    Age categorical
    Subjects aged 18-75 years were enrolled in the trial
    Units: Subjects
        Adults (18-75 years)
    94
    18
    17
    19
    19
    5
    5
    5
    5
    38
    35
    10
    10
    37
    36
    10
    10
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    86
    15
    17
    19
    16
    5
    5
    5
    4
    35
    32
    10
    9
    31
    36
    9
    10
        Male
    8
    3
    0
    1
    3
    0
    0
    0
    1
    4
    3
    0
    1
    6
    1
    1
    0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 In arm A patients with cutis laxa or scarring received a dose of stem cell suspension isolated from lipoaspirate and then injected into the patient's skin. Patients received treatment in two schemes. In Scheme I (SVF) patients received a fresh fraction of cells isolated from adipose tissue (not subjected to in vitro culture). This is the so-called stromal vascular fraction. Some SVF cells were frozen and some were prepared in cell culture for the second and subsequent applications in the patient. In Scheme II (ADSC) the first application of the cultured cell suspension took place 6-12 days after the liposuction/lipoaspiration procedure. Some cells were cryopreserved and after thawing prepared in cell culture for the second and subsequent applications in the patient.

    Reporting group title
    Placebo
    Reporting group description
    		 In arm B, placebo was administered to a hand or two scars or a single scar. The placebo was a 0.9% NaCl (saline) solution injected using the same procedure as for the stem cell suspension.

    Subject analysis set title
    All patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis

    Subject analysis set title
    Arm A Scarring SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm A Cutis laxa SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm A Cutis laxa ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm A Scarring ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm B Cutis laxa ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B Scarring ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B Cutis laxa SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm B Scarring SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm A ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered active treatment in Scheme II (ADSC)

    Subject analysis set title
    Arm A SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered active treatment in Scheme I (SVF)

    Subject analysis set title
    Arm B ADSC
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered placebo in Scheme II (ADSC)

    Subject analysis set title
    Arm B SVF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients administered placebo in Scheme I (SVF)

    Subject analysis set title
    Arm A Scarring
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring administered active treatment

    Subject analysis set title
    Arm A Cutis laxa
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered active treatment

    Subject analysis set title
    Arm B Scarring
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with scarring, administered placebo

    Subject analysis set title
    Arm B Cutis laxa
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with cutis laxa, administered placebo

    Primary: Time taken to see a 50% improvement in the patient's quality of life score from baseline

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    End point title
    		 Time taken to see a 50% improvement in the patient's quality of life score from baseline
    End point description
    End point type
    Primary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Placebo Arm A Scarring SVF Arm A Cutis laxa ADSC Arm A Scarring ADSC Arm B Cutis laxa ADSC Arm B Scarring ADSC Arm B Scarring SVF Arm A ADSC Arm A SVF Arm B ADSC Arm B SVF Arm A Scarring Arm A Cutis laxa Arm B Scarring Arm B Cutis laxa
    Number of subjects analysed
    74
    20
    18
    19
    19
    5
    5
    5
    38
    35
    10
    10
    37
    36
    10
    10
    Units: weeks
        arithmetic mean (standard error)
    22.6 ( 0.8 )
    23.4 ( 1.6 )
    23.3 ( 1.7 )
    21.5 ( 2.0 )
    21.3 ( 2.1 )
    25.5 ( 0.0 )
    25.5 ( 0.0 )
    17.1 ( 4.6 )
    21.4 ( 1.4 )
    23.8 ( 1.0 )
    25.5 ( 0.0 )
    21.3 ( 2.7 )
    22.3 ( 1.3 )
    22.8 ( 1.2 )
    21.3 ( 3.1 )
    25.5 ( 0.0 )
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Placebo v Arm A
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.869
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A Scarring v Arm B Scarring
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.515
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A Cutis laxa v Arm B Cutis laxa
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.334
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A Scarring ADSC v Arm B Scarring ADSC
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.903
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A Scarring SVF v Arm B Scarring SVF
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.454
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A Cutis laxa ADSC v Arm B Cutis laxa ADSC
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.757
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A ADSC v Arm B ADSC
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.918
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Log Rank (Mantel-Cox)
    Comparison groups
    Arm A SVF v Arm B SVF
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.869
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm A v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.877
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm B Scarring v Arm A Scarring
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.546
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm A Cutis laxa v Arm B Cutis laxa
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm A Scarring ADSC v Arm B Scarring ADSC
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.909
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm B Scarring SVF v Arm A Scarring SVF
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm B Cutis laxa ADSC v Arm A Cutis laxa ADSC
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.765
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm B ADSC v Arm A ADSC
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.922
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Univariate Cox hazard models
    Comparison groups
    Arm A SVF v Arm B SVF
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.876
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Multivariate Cox hazard models
    Comparison groups
    Arm A v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.878
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Multivariate Cox hazard models
    Comparison groups
    Arm B Scarring v Arm A Scarring
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.557
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Multivariate Cox hazard models
    Comparison groups
    Arm A Cutis laxa v Arm B Cutis laxa
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Change in the assessment of skin lesions

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    End point title
    		 Change in the assessment of skin lesions
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Cutis laxa SVF Arm A Cutis laxa ADSC Arm A Scarring ADSC Arm B Cutis laxa ADSC Arm B Scarring ADSC Arm B Cutis laxa SVF Arm B Scarring SVF Arm A ADSC Arm A SVF Arm B ADSC Arm B SVF
    Number of subjects analysed
    18
    17
    19
    19
    5
    5
    5
    5
    38
    35
    10
    10
    Units: scale
        arithmetic mean (standard deviation)
    -9.00 ( 13.44 )
    -9.41 ( 17.91 )
    -6.26 ( 19.10 )
    -10.95 ( 12.34 )
    -11.40 ( 11.39 )
    -11.80 ( 13.12 )
    -4.40 ( 5.77 )
    -19.80 ( 20.03 )
    -8.61 ( 16.04 )
    -9.20 ( 15.53 )
    -11.60 ( 11.59 )
    -12.10 ( 16.09 )
    No statistical analyses for this end point

    Secondary: Change in the thickness of the scar on ultrasound

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    End point title
    		 Change in the thickness of the scar on ultrasound
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    0.03 ( 0.88 )
    -0.08 ( 0.82 )
    0.50 ( 0.55 )
    0.13 ( 0.70 )
    No statistical analyses for this end point

    Secondary: Change in the thickness of the subcutaneous tissue on ultrasound

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    End point title
    		 Change in the thickness of the subcutaneous tissue on ultrasound
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    -1.45 ( 11.43 )
    3.18 ( 10.58 )
    -2.22 ( 8.40 )
    0.55 ( 1.17 )
    No statistical analyses for this end point

    Secondary: Change in the color of the scar as assessed by the investigator

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    End point title
    		 Change in the color of the scar as assessed by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -0.88 ( 0.60 )
    -1.32 ( 0.67 )
    -1.00 ( 0.71 )
    -1.20 ( 0.45 )
    No statistical analyses for this end point

    Secondary: Change in the appearance of the scar as assessed by the investigator

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    End point title
    		 Change in the appearance of the scar as assessed by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -0.41 ( 0.51 )
    -0.42 ( 0.51 )
    -0.20 ( 0.45 )
    -0.60 ( 0.55 )
    No statistical analyses for this end point

    Secondary: Change in the prominence of the scar as assessed by the investigator

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    End point title
    		 Change in the prominence of the scar as assessed by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -0.88 ( 0.93 )
    -0.95 ( 0.85 )
    -0.60 ( 0.55 )
    -1.20 ( 0.84 )
    No statistical analyses for this end point

    Secondary: Change in scar deformation as assessed by the investigator

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    End point title
    		 Change in scar deformation as assessed by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.29 ( 0.59 )
    -1.21 ( 0.63 )
    -0.80 ( 0.45 )
    -0.60 ( 0.89 )
    No statistical analyses for this end point

    Secondary: Change in the structure of the scar as assessed by the investigator

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    End point title
    		 Change in the structure of the scar as assessed by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.06 ( 0.75 )
    -1.26 ( 0.65 )
    -1.00 ( 0.71 )
    -1.60 ( 0.55 )
    No statistical analyses for this end point

    Secondary: Change in pain as assessed by the patient

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    End point title
    		 Change in pain as assessed by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -0.06 ( 0.42 )
    -0.16 ( 0.83 )
    0.00 ( 0.00 )
    -1.20 ( 1.64 )
    No statistical analyses for this end point

    Secondary: Change in itching as assessed by the patient

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    End point title
    		 Change in itching as assessed by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -0.11 ( 0.68 )
    -0.21 ( 0.79 )
    0.00 ( 0.00 )
    -0.80 ( 1.30 )
    No statistical analyses for this end point

    Secondary: Change in the color of the scar as assessed by the patient

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    End point title
    		 Change in the color of the scar as assessed by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.83 ( 1.50 )
    -1.58 ( 1.50 )
    -1.60 ( 3.36 )
    -3.00 ( 1.58 )
    No statistical analyses for this end point

    Secondary: Change in scar thickness as assessed by the patient

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    End point title
    		 Change in scar thickness as assessed by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.89 ( 1.60 )
    -1.11 ( 1.52 )
    -1.80 ( 0.84 )
    -2.60 ( 2.30 )
    No statistical analyses for this end point

    Secondary: Change in scar irregularity as assessed by the patient

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    End point title
    		 Change in scar irregularity as assessed by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Scarring SVF Arm A Scarring ADSC Arm B Scarring ADSC Arm B Scarring SVF
    Number of subjects analysed
    18
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.61 ( 1.29 )
    -1.05 ( 1.61 )
    -1.40 ( 1.14 )
    -2.80 ( 2.17 )
    No statistical analyses for this end point

    Secondary: Change in skin thickness on ultrasound

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    End point title
    		 Change in skin thickness on ultrasound
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Cutis laxa SVF Arm A Cutis laxa ADSC Arm B Cutis laxa ADSC Arm B Cutis laxa SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    0.25 ( 0.25 )
    0.22 ( 0.17 )
    0.24 ( 0.14 )
    0.37 ( 0.28 )
    No statistical analyses for this end point

    Secondary: Change in the thickness of the subcutaneous tissue on ultrasound

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    End point title
    		 Change in the thickness of the subcutaneous tissue on ultrasound
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Cutis laxa SVF Arm A Cutis laxa ADSC Arm B Cutis laxa ADSC Arm B Cutis laxa SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: mm
        arithmetic mean (standard deviation)
    0.54 ( 1.14 )
    0.74 ( 0.82 )
    0.75 ( 1.02 )
    1.13 ( 0.59 )
    No statistical analyses for this end point

    Secondary: Change in the degradation of subcutaneous tissue

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    End point title
    		 Change in the degradation of subcutaneous tissue
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, week 4-5, week 8-9, week 24-27 and on early termination of the study
    End point values
    		 Arm A Cutis laxa SVF Arm A Cutis laxa ADSC Arm B Cutis laxa ADSC Arm B Cutis laxa SVF
    Number of subjects analysed
    17
    19
    5
    5
    Units: scale
        arithmetic mean (standard deviation)
    -1.12 ( 0.78 )
    -1.16 ( 0.90 )
    -1.00 ( 1.22 )
    -1.40 ( 0.89 )
    No statistical analyses for this end point

    Secondary: Evaluation of the safety of the application method by assessment of adverse reactions

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    End point title
    		 Evaluation of the safety of the application method by assessment of adverse reactions
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments were performed on day 0, day 0 +1 day, day 6-12, week 2, week 4-5, week 6, week 8-9, week 10, week 24-27 and on early termination of the study
    End point values
    		 All patients
    Number of subjects analysed
    94
    Units: number od adverse reactions
    150
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Assessment of adverse events was conducted from day 0 to the end of clinical trial (week 24-27).
    Adverse event reporting additional description
    Assessments were performed on day 0, day 0 +1 day, day 6-12, week 2, week 4-5, week 6, week 8-9, week 10, week 24-27 and on early termination of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 other
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 94 (1.06%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Blood pressure increased
    Additional description: Patient 2ABC01016 experienced SAE that was hospitalization for increased blood pressure. Patient recovered completely. In the investigator's opinion, it was not related to the test product, but administration of the product was discontinued.
         subjects affected / exposed
    1 / 94 (1.06%)
         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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 94 (58.51%)
    General disorders and administration site conditions
    Swelling
    Additional description: Swelling after mesotherapy
         subjects affected / exposed
    4 / 94 (4.26%)
         occurrences all number
    7
    Erythema
    Additional description: Skin erythema after mesotherapy
         subjects affected / exposed
    7 / 94 (7.45%)
         occurrences all number
    9
    Dry skin
    Additional description: Hand skin roughness or dryness after mesotherapy
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    5
    Skin injury
    Additional description: Bruising hand skin at the application site
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Skin irritation
    Additional description: Itching of the hand skin at the application site
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Skin sensitisation
    Additional description: Paresthesia after liposuction
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    2
    Pain
    Additional description: Pain associated with liposuction
         subjects affected / exposed
    13 / 94 (13.83%)
         occurrences all number
    14
    Blood pressure increased
    Additional description: Increased blood pressure
         subjects affected / exposed
    4 / 94 (4.26%)
         occurrences all number
    4
    Abdominal pain
    Additional description: Stabbing pain in the lower left abdominal quadrant
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Throat irritation
    Additional description: Sore throat
         subjects affected / exposed
    4 / 94 (4.26%)
         occurrences all number
    4
    Rhinitis
    Additional description: Watery rhinitis
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Headache
    Additional description: Headache
         subjects affected / exposed
    13 / 94 (13.83%)
         occurrences all number
    25
    Tremor
    Additional description: Symptoms of tremor combined with an episode of increased blood pressure (160/98)
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Pharyngitis
    Additional description: Acute pharyngitis
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Immune system disorders
    Allergy to plants
    Additional description: Birch pollen allergy
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    2
    Allergic respiratory disease
    Additional description: Respiratory allergy
         subjects affected / exposed
    5 / 94 (5.32%)
         occurrences all number
    6
    Eye allergy
    Additional description: Itching and redness of the conjunctiva of both eyes of an allergic nature
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Menstruation irregular
    Additional description: Occurrence of menstrual bleeding after an 8-month break
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Menopausal symptoms
    Additional description: Perimenopausal symptoms
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
    Additional description: Infection of the upper or lower respiratory tract, common cold
         subjects affected / exposed
    16 / 94 (17.02%)
         occurrences all number
    18
    Sinusitis
    Additional description: Inflammation of the paranasal sinuses
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Cough
    Additional description: Cough
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Asthma
    Additional description: Asthmatic symptoms (exacerbation of periodically occurring dyspnoea in the spring)
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Nervous system disorders
    Migraine
    Additional description: Migraine headache
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Oedema peripheral
    Additional description: Painless swelling of lower legs
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Iron deficiency
    Additional description: Low serum iron levels (up to 55 mcg/ml)
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Otitis media acute
    Additional description: Acute otitis media
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Eye disorders
    Lacrimation increased
    Additional description: Lacrimation acompanied by a runny nose
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Conjunctivitis
    Additional description: Conjunctivitis of both eyes
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    2
    Gastrointestinal disorders
    Gastric pH increased
    Additional description: Gastric hyperacidity
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    2
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Vitiligo
    Additional description: Vitiligo in the place of the scar on the hand after laser treatment
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Inflammation
    Additional description: Nonspecific inflammation of the soft tissues of the hands with massive swelling; inflammatory lump on the forearm
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    4
    Scar pain
    Additional description: Pain in the scar area
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Haemorrhage subcutaneous
    Additional description: Subcutaneous hemorrhage under the eye
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Urticaria
    Additional description: Acute urticaria
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Skin reaction
    Additional description: Skin allergy
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Ankle deformity
    Additional description: Right ankle sprain
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Back pain
    Additional description: Spine pain
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences all number
    3
    Tooth fracture
    Additional description: Fracture in the root of the lower left IV tooth
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Pain in extremity
    Additional description: Lower limb pain in the area of the left shin; pain in the left shoulder area; hip pain
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences all number
    3
    Finger deformity
    Additional description: Injury of fourth finger of the right hand
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1
    Formication
    Additional description: Formication and numbness of both hands radiating to the elbows
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    2
    Infections and infestations
    Viral infection
    Additional description: Shingles
         subjects affected / exposed
    2 / 94 (2.13%)
         occurrences all number
    2
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    3 / 94 (3.19%)
         occurrences all number
    4
    Bite
    Additional description: Tick bite
         subjects affected / exposed
    1 / 94 (1.06%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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