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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    ENSAYO CLINICO FASE II MULTICENTRICO, ABIERTO Y ALEATORIZADO SOBRE EL USO TERAPEUTICO DE LA INFUSION INTRAARTERIAL DE CÉLULAS MONONUCLEADAS DE MÉDULA ÓSEA AUTÓLOGA EN PACIENTES NO DIABÉTICOS CON ISQUEMIA CRÓNICA CRÍTICA DE MIEMBROS INFERIORES

    Summary
    EudraCT number
    		 2009-013636-20
    Trial protocol
    		 ES  
    Global end of trial date
    29 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
    CMMo/ICC/2009
    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
    29 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluar la seguridad y factibilidad del autotrasplante de células mononucleadas de médula ósea (mo-CMNs) autóloga administradas por vía intraarterial en el miembro afecto de pacientes no diabéticos con isquemia crónica crítica de los miembros inferiores sin posibilidades de revascularización ni otras alternativas terapéuticas.
    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
    01 Jul 2009
    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
    Spain: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    From 65 to 84 years
    0
    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
    		 28 [1]
    Number of subjects completed
    		 28

    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: It is detailed in the summary of the clinical report
    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 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unexpanded autologous bone marrow adult mononuclear stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1x10e8 moCMNs

    Arm title
    		 Group 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unexpanded autologous bone marrow adult mononuclear stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5x10e8 moCMNs

    Arm title
    		 Group 3
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unexpanded autologous bone marrow adult mononuclear stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1x10e9 moCMNs

    Number of subjects in period 1 [2]
    		Group 1 Group 2 Group 3
    Started
    9
    11
    8
    Completed
    9
    11
    8
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: It is detailed in the summary of the clinical report

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment and follow-up
    Reporting group description
    		 -

    Reporting group values
    		 Recruitment and follow-up Total
    Number of subjects
    		 28 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 -

    Reporting group title
    Group 2
    Reporting group description
    		 -

    Reporting group title
    Group 3
    Reporting group description
    		 -

    Primary: Safety and feasibility

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    End point title
    		 Safety and feasibility [1]
    End point description
    To evaluate the safety and feasibility of autotransplantation of mononucleated marrow cells autologous bone, administered intra-arterially in non-diabetic patients with ischemia chronic critical condition of the lower limbs without the possibility of revascularization or other therapeutic alternatives.
    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: It is detailed in the summary of the clinical report
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    9
    11
    8
    Units: units
    9
    11
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    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
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: It is detailed in the summary of the clinical report

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2009
    changes in the research team
    29 Mar 2011
    new participating centers are added
    08 May 2012
    The monitoring period is modified
    10 Jun 2013
    The sample size is decreased

    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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