Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Clinical Trial Phase II Multicenter Open Randomized Trial of the Therapeutic Use of Cells Intraportal Infusion of Autologous Bone Marrow Mononuclear as Enhancing Liver Regeneration Prior to Performing Extended Hepatic Resection.

    Summary
    EudraCT number
    		 2009-017793-20
    Trial protocol
    		 ES  
    Global end of trial date
    20 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2023
    First version publication date
    01 Dec 2023
    Other versions
    Summary report(s)
    		 Final Report_summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CMMo/RH/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., +34 955 048 366, terapias.avanzadas@juntadeandalucia.es
    Scientific contact
    Rosario Carmen Mata Alcázar-Caballero , Fundación Pública Andaluza Progreso y Salud M.P., +34 955 048 366, terapias.avanzadas@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
    01 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility and safety of autologous bone narrow mononuclear cells as enhancer of hepetic regeneration
    Protection of trial subjects
    All patients have the right to discontinue the study at any time and may be withdrawn from the study for any reason of benefit to their well-being. On the other hand, in accordance with good clinical practice, those patients who have abandoned the study prematurely will have been recommended another alternative and, in the event that the cause has been a significant Adverse Event, the patients have been controlled by the investigator until appropriate termination, that is, until the adverse event has disappeared or until it has been determined to be permanent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 14 patients were included (after signing the consent) being one a selection fault and, consequently, 13 measurable patients according to the definition of population by intention of being treated. These patients were randomly assigned to one of the intervention groups (6 patients in group 1 (study) / 7 patients in group 2 (control).

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 13
    Number of subjects completed
    		 13

    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
    		 Study group (CMMo)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CMMo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraportal use
    Dosage and administration details
    A single dose of bone marrow mononucleated cells (10 ml)

    Arm title
    		 Group 2
    Arm description
    		 Control
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group 1 Group 2
    Started
    6
    7
    Completed
    6
    7

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Study group (CMMo)

    Reporting group title
    Group 2
    Reporting group description
    		 Control

    Subject analysis set title
    Feasibility and safety
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Feasibility and safety

    Primary: Feasibility

    		 Close Top of page
    End point title
    		 Feasibility [1]
    End point description
    End point type
    Primary
    End point timeframe
    From the inclusion of the first patient to the last visit of the last patient
    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 1 Group 2
    Number of subjects analysed
    6
    7
    Units: units
    6
    7
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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
    Haemorrhagic shock
    Reporting group description
    		 -

    Reporting group title
    Subphrenic collection
    Reporting group description
    		 -

    Reporting group title
    Pulmonary thromboembolism
    Reporting group description
    		 -

    Reporting group title
    Bradycardia
    Reporting group description
    		 -

    Reporting group title
    Fever
    Reporting group description
    		 -

    Reporting group title
    Intra-abdominal biliary
    Reporting group description
    		 -

    Reporting group title
    Persistence of biliary collection
    Reporting group description
    		 -

    Serious adverse events
    		 Haemorrhagic shock Subphrenic collection Pulmonary thromboembolism Bradycardia Fever Intra-abdominal biliary Persistence of biliary collection
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Haemorrhagic shock Subphrenic collection Pulmonary thromboembolism Bradycardia Fever Intra-abdominal biliary Persistence of biliary collection
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Haemorrhagic shock
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary tromboembolism
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Intra-abdominal biliary
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Persistence of biliary collection
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Subphrenic collection
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Fever
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2009
    Investigational therapy and stem cell application procedure
    30 Jan 2011
    New centres have been included and some exclusion criteria have been modified
    10 Oct 2011
    Some inclusion and exclusion criteria have been modified. Some centers are also added

    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
    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.

    European Medicines Agency © 1995-Tue Apr 30 05:04:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA