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    Clinical Trial Results:
    A Danish, single centre, double-blind, randomized study evaluating allogeneic adipose tissue derived mesenchymal stromal cell therapy to reduce primary graft dysfunction after lung transplantation. A phase I-II study

    Summary
    EudraCT number
    		 2019-004848-30
    Trial protocol
    		 DK  
    Global end of trial date
    10 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Oct 2024
    First version publication date
    05 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12.12.2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Jens Kastrup, Rigshospitalet, 45 35452819, jens.kastrup@regionh.dk
    Scientific contact
    Jens Kastrup, Rigshospitalet, 45 35452819, jens.kastrup@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate safety of treatment with allogeneic adipose tissue-derived mesenchymal stromal cells (ASCs) in patients undergoing lung transplantation, to evaluate whether the treatment can reduce host immunological reaction towards the graft, and to reduce the ischemic reperfusion-injury after transplantation.
    Protection of trial subjects
    The study was approved by the National Committee on Health Research Ethics, the Danish Health and Medicines Agency and the Data Inspectorate. The study responsible persons had access to health care data from the patient’s records. This information was important to ensure that the patients fulfil all the protocol criteria and approvals from the authorities. The study was monitored by the GCP-unit, Capital region of Denmark. Representatives from these authorities and the responsible for the clinical trial had access to all patient and study data. This control ensured that the clinical study was conducted in accordance with the approved protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2020
    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
    Denmark: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    26
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ten women and 20 men were treated with 200 million ASCs (n=10), 100 million ASCs (n=10) or saline infusion (n=10). No statistically significant differences in major baseline characteristics were observed between the three groups except in forced vital capacity and quality of life activity score. Randomization was performed using an online tool.

    Pre-assignment
    Screening details
    		 Thirty-one patients were included from December 2020 to April 2023. During transplantation, one patient developed an unexpected need for extra corporal membrane oxygenation and thus was excluded before ASC/placebo treatment according to the in- and exclusion criteria.

    Period 1
    Period 1 title
    Inclusion period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    Patients were randomized in blocks of six using a web program RANDOM.ORG - List Randomizer [Internet]. https://www.random.org/lists/ CSCC was responsible for the randomization code and for preparing the cell product in infusion bag, to assure blinding of the treatment for the clinical team. It was not possible to see whether it was 200 or 100 million ASCs or placebo (saline) in the prepared infusion bag.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ASC 200
    Arm description
    		 Patients receiving 200 million ASCs
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASC_CSCC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Allogeneic 200 million ASCs

    Arm title
    		 ASC 100
    Arm description
    		 Patients recieving 100 mio. ASCs
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASC_CSCC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Allogeneic 100 million ASCs

    Arm title
    		 Placebo
    Arm description
    		 Saline infusion
    Arm type
    		 Placebo

    Investigational medicinal product name
    Isotonic saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Isotonic saline infusion

    Number of subjects in period 1
    		ASC 200 ASC 100 Placebo
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASC 200
    Reporting group description
    		 Patients receiving 200 million ASCs

    Reporting group title
    ASC 100
    Reporting group description
    		 Patients recieving 100 mio. ASCs

    Reporting group title
    Placebo
    Reporting group description
    		 Saline infusion

    Reporting group values
    		 ASC 200 ASC 100 Placebo Total
    Number of subjects
    		 10 10 10 30
    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
    Age in years
    Units: years
        arithmetic mean (standard deviation)
    		 55.5 ( 6.8 ) 59.6 ( 5.6 ) 55.6 ( 6.2 ) -
    Gender categorical
    Gender M/F
    Units: Subjects
        Female
    		 4 3 3 10
        Male
    		 6 7 7 20
    Subject analysis sets

    Subject analysis set title
    overall
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Statistical analysis was performed using SPSS version 29 (SPSS Inc., Chicago, Illinois). Continuous variables are presented as mean±standard deviation and categorical variables are presented as numbers and percentages. Categorical data are compared using Fisher’s exact or Chi-square test as appropriate. Analysis of variances (Anova) is used to compare more than two groups for normal data distribution. A two-sided P-value of<0.05 is considered statistically significant. It was predefined in the protocol that the ASC groups would be analysed alone and combined against the placebo group.

    Subject analysis sets values
    		 overall
    Number of subjects
    30
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Age in years
    Units: years
        arithmetic mean (standard deviation)
    56.9 ( 6.3 )
    Gender categorical
    Gender M/F
    Units: Subjects
        Female
    10
        Male
    20

    End points

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    End points reporting groups
    Reporting group title
    ASC 200
    Reporting group description
    		 Patients receiving 200 million ASCs

    Reporting group title
    ASC 100
    Reporting group description
    		 Patients recieving 100 mio. ASCs

    Reporting group title
    Placebo
    Reporting group description
    		 Saline infusion

    Subject analysis set title
    overall
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Statistical analysis was performed using SPSS version 29 (SPSS Inc., Chicago, Illinois). Continuous variables are presented as mean±standard deviation and categorical variables are presented as numbers and percentages. Categorical data are compared using Fisher’s exact or Chi-square test as appropriate. Analysis of variances (Anova) is used to compare more than two groups for normal data distribution. A two-sided P-value of<0.05 is considered statistically significant. It was predefined in the protocol that the ASC groups would be analysed alone and combined against the placebo group.

    Primary: PGD

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    End point title
    		 PGD
    End point description
    PGD was defined according to the International Society for Heart and Lung Transplantation (ISHLT) as pulmonary infiltrates and hypoxemia occurring in the first 72 hours after transplantation. PGD was graded every 24 hours during the first 72 hours after transplantation. Time started at reperfusion of the second lung. PGD was analysed and graded by two independent consultants with expertise in lung transplantations and blinded to the patient’s treatment status. If there was disagreement in PGD, consensus had to be reached.
    End point type
    Primary
    End point timeframe
    72 hours
    End point values
    		 ASC 200 ASC 100 Placebo
    Number of subjects analysed
    10
    10
    10
    Units: noon unit
        number (not applicable)
    10
    7
    14
    Statistical analysis title
    		 Per protocol
    Statistical analysis description
    Statistical analysis was performed using SPSS version 29 (SPSS Inc., Chicago, Illinois). Continuous variables are presented as mean±standard deviation and categorical variables are presented as numbers and percentages. Categorical data are compared using Fisher’s exact or Chi-square test as appropriate. Analysis of variances (Anova) is used to compare more than two groups for normal data distribution. A two-sided P-value of<0.05 is considered statistically significant. It was predefined in the p
    Comparison groups
    ASC 200 v ASC 100 v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Final follow-up after 3 months
    Adverse event reporting additional description
    Please see SAE section
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Danish authorities
    Dictionary version
    1
    Reporting groups
    Reporting group title
    ASC 200
    Reporting group description
    		 Patients receiving 200 million ASCs

    Reporting group title
    ASC 100
    Reporting group description
    		 Patients recieving 100 mio. ASCs

    Reporting group title
    Placebo
    Reporting group description
    		 Saline infusion

    Serious adverse events
    		 ASC 200 ASC 100 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    4 / 10 (40.00%)
    5 / 10 (50.00%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Cardiomyopathy acute
    Additional description: Takutsubo cardiomyopathy
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (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
    Immune system disorders
    Acute cellular rejection
    Additional description: Acute cellular rejection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (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
    Respiratory, thoracic and mediastinal disorders
    Death
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (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
    Pleural effusion
    Additional description: Recurrent pleural effusion
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (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
    recurrent laryngeal nervous paresis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic disorder
    Additional description: Diaphragm paralysis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (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
    Breast abscess
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (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
    Pneumonia
    Additional description: pneumonia, bacterial, viral and fungal
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ASC 200 ASC 100 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    Respiratory, thoracic and mediastinal disorders
    Breast abscess
    Additional description: Please see SAE section
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (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? 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.
    A small phase I/II trial
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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