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    Clinical Trial Results:
    Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients

    Summary
    EudraCT number
    		 2008-001837-88
    Trial protocol
    		 ES  
    Global end of trial date
    26 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions
    Summary report(s)
    		 Final Report_Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    CeTMAd/ICPD/2008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Pública Andaluza Progreso y Salud M.P.
    Sponsor organisation address
    Avda. Américo Vespucio 15 · Edificio S-2 · 2ª Pta, Sevilla, Spain, 41092
    Public contact
    ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es
    Scientific contact
    ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es
    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
    26 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of regenerative treatment with adipose tissue mesenchymal stem cells (CeTMAd), administered intra-arterially in diabetic patients with critical ischemia of at least one lower limb and without the possibility of revascularization or other therapeutic alternatives. Complications derived from regenerative therapy and/or study procedures will be analyzed: - The generation of new vessels (vasculogenesis) and the enhancement of collateral circulation (angiogenesis) will be studied. - Complications derived from the procedure will be studied in the first 24h of CeTMAd administration, 1 month, 3 months, 6 months, 9 months and 12 months.
    Protection of trial subjects
    The trial has been carried out in accordance with the recommendations for Clinical Trials and the evaluation of the product under investigation in humans, which appear in the Declaration of Helsinki, revised in successive world assemblies (WMA, 2008), and the current Spanish Legislation on Clinical Trials. In addition, the ICH-GPC standards have been followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    11
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 29
    Number of subjects completed
    		 29

    Period 1
    Period 1 title
    Recruitment and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AUTOLOGOUS ADIPOSE TISSUE ADIPOSE TISSUE ADULT STEM MESENCHYMAL CELLS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intraarterial use
    Dosage and administration details
    0,5 X 10^6 CÉLULAS/KG

    Arm title
    		 Group B
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AUTOLOGOUS ADIPOSE TISSUE ADIPOSE TISSUE ADULT STEM MESENCHYMAL CELLS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intraarterial use
    Dosage and administration details
    10 X 10^6 CÉLULAS/KG

    Arm title
    		 Group control
    Arm description
    		 -
    Arm type
    		 Usual clinical practice

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group A Group B Group control
    Started
    10
    10
    9
    Completed
    10
    10
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Reporting group title
    Group control
    Reporting group description
    		 -

    Reporting group values
    		 Group A Group B Group control Total
    Number of subjects
    		 10 10 9 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 10 10 9 29
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.5 ( 9.3 ) 66.5 ( 9.3 ) 66.6 ( 14.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 6 4 15
        Male
    		 5 4 5 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 10 9 29
        From 65-84 years
    		 0 0 0 0
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 10 10 9 29
        85 years and over
    		 0 0 0 0
    Safety
    Units: units
        arithmetic mean (standard deviation)
    		 65.5 ( 9.3 ) 66.5 ( 9.3 ) 66.6 ( 14.8 ) -
    Subject analysis sets

    Subject analysis set title
    Feasibility and safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Assess the safety and feasibility of treatment regenerative with mesenchymal stem cells of adipose tissue administered intra-arterially in Diabetic patients with critical chronic ischemia of lower limbs and without the possibility of revascularization or other therapeutic alternatives.

    Subject analysis sets values
    		 Feasibility and safety
    Number of subjects
    29
    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)
    9
        From 65-84 years
    20
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65,8 ( 0,5 )
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    25
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    20
        From 65-84 years
    9
    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)
    20
        From 65-84 years
    9
        85 years and over
    0
    Safety
    Units: units
        arithmetic mean (standard deviation)
    65,8 ( 11 )

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Reporting group title
    Group control
    Reporting group description
    		 -

    Subject analysis set title
    Feasibility and safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Assess the safety and feasibility of treatment regenerative with mesenchymal stem cells of adipose tissue administered intra-arterially in Diabetic patients with critical chronic ischemia of lower limbs and without the possibility of revascularization or other therapeutic alternatives.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    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 analyses for this end point
    End point values
    		 Group A Group B Group control Feasibility and safety
    Number of subjects analysed
    10
    10
    9
    Units: units
    10
    10
    9
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the inclusion of the first patient to the last visit of the last patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Group control
    Reporting group description
    		 -

    Serious adverse events
    		 Group control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    Renal and urinary disorders
    urinary infection
         subjects affected / exposed
    5 / 10 (50.00%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2010
    Some of the exclusion criteria have been modified.
    10 Jan 2011
    The total number of patients to be recruited is modified
    20 Apr 2012
    Ophthalmoscopy is therefore eliminated as a Test of the Trial

    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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