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    Clinical Trial Results:
    Clinical trial Phase I/II, test of concept, double blind, randomized, controlled with placebo, to evalue the safety and efficiency of the treatment with expanded adult mesenchymal stem cells from allogenic adipose tissue, in patients with HIV infection with controlled viral load and immunological discordant response.

    Summary
    EudraCT number
    		 2014-000307-26
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2024
    First version publication date
    14 Feb 2024
    Other versions
    Summary report(s)
    		 CeTMAd-VIH-2014
    CeTMAd-VIH-2014

    Trial information

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    Trial identification
    Sponsor protocol code
    CeTMAd-VIH-2014
    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, Sevilla, Spain,
    Public contact
    Ana Cardesa Gil, Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud, +34 NA955048366NA, ana.cardesa@juntadeandalucia.es
    Scientific contact
    Ana Cardesa Gil, Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud, +34 NA955048366NA, ana.cardesa@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
    27 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the safety of the intravenous infusion of 4 doses of allogenic mesenchimal stem cells from adipose tissue (ASC), in patients with infection for HIV and immunological discordant response. 2. To evaluate the efficiency of the intravenous infusion of 4 ASC's doses in the immunological recovery after 3 monthly cycles of CeTMAd's infusion and 1 additional infusion in week 20 in patients with infection for HIV and immunological discordant response.
    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 Jun 2016
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    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
    		 5
    Number of subjects completed
    		 5

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

    Arms
    Arm title
    		 Group A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CeTMAd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intraarterial use
    Dosage and administration details
    0.5x106 células / kg peso paciente.

    Number of subjects in period 1
    		Group A
    Started
    5
    Completed
    5

    Baseline characteristics

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

    Reporting group values
    		 Group A Total
    Number of subjects
    		 5 5
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 5 5

    End points

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

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

    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: Information included in summary
    End point values
    		 Group A Feasibility and safety
    Number of subjects analysed
    5
    5
    Units: units
    5
    5
    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 1
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    Vascular disorders
    venous thrombosis
         subjects affected / exposed
    5 / 5 (100.00%)
         occurrences all number
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Sep 2016
    The use of premedication is considered before each CetMAd infusion. Update of co-investigators and inclusion of the UPCIT of the CHUGr as the center involved in the trial. Update of the scale for the gradation of AAs (DAIDs table), of the clinical trial schedule repealed regulations (EECC, donation of tissues and TAs), and of the methods accepted contraceptives.

    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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