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    Clinical Trial Results:
    Clinical trial phase I/II multicentric, open, randomized and controlled for the study of stem cells as therapy critical ischemia in low limbs in insulinized type 2 diabetic patients: study of the insulin

    Summary
    EudraCT number
    		 2010-019774-33
    Trial protocol
    		 ES  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2021
    First version publication date
    09 Apr 2021
    Other versions
    Summary report(s)
    		 Clinical Report

    Trial information

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    Trial identification
    Sponsor protocol code
    CeTMMoTa/ICPDI/2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Red Andaluza de Diseño y Traslación en Terapias Avanzadas (former Iniciativa Andaluza en Terapias Avanzadas) – Fundación Progreso y Salud
    Sponsor organisation address
    Avda. Américo Vespucio 15 · Edificio S-2 ·2ª Pta., Sevilla, Spain,
    Public contact
    Rosario Carmen Mata Alcázar-Caballero, Red Andaluza de Diseño y Traslación en Terapias Avanzadas – Fundación Progreso y Salud, +34 955 048 366, terapias.avanzadas@juntadeandalucia.es
    Scientific contact
    Rosario Carmen Mata Alcázar-Caballero, Red Andaluza de Diseño y Traslación en Terapias Avanzadas – Fundación Progreso y Salud, +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
    20 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effect of the infusion intrarterial of mononuclear cells of bony marrow, cells CD133 + and cells mesenquimales of adipose tissue, on the inflammatory citoquinas, the resistance to the insulin and the decrease of the needs of this one, beside to evaluate the safety, viability and efficiency of the intra-arterial injection of cells in diabetic patients type 2. The aims of the study gather in efficiency and safety. - Safety: there will be evaluated the possible complications derived from the procedure in the first 24 hours after the administration of stem cells. - Efficiency: quantification of the degree of neovascularizacion (angio/arteriogenesis and vasculogenesis) to 6 months of the administration
    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
    15 Sep 2011
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    9
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Type 2 diabetic, on insulin treatment for at least 3 previous months. Severe grade atherosclerotic infrapopliteal vascular disease (patients with Rutherford-Becker category ≥4), mono or bilateral. Impossibility of surgical or endovascular revascularization or failure of revascularization surgery. Life expectancy> 2 year.

    Pre-assignment
    Screening details
    		 The predicted population was 48 clinically evaluable diabetic patients with critical chronic ischemia of at least one lower limb and no possibility of revascularization. Finally, it was not possible to reach the predicted “n”, including 20 patients who were randomized to the 4 predicted groups.

    Period 1
    Period 1 title
    Recruitment and follow-up
    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
    		 Expanded autologous adipose tissue adult mesenchymal stem cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Expanded autologous adipose tissue adult mesenchymal stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5x10E6 cells/kg

    Arm title
    		 Group B
    Arm description
    		 CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2-7 x10E6 CD133+ cells

    Arm title
    		 Group C
    Arm description
    		 Unexpanded autologous bone marrow adult mononuclear stem cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unexpanded autologous bone marrow adult mononuclear stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150-250 x 10E6 cells

    Arm title
    		 Group D
    Arm description
    		 Conventional treatment
    Arm type
    		 Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    8
    6
    3
    3
    Completed
    8
    6
    3
    3
    Period 2
    Period 2 title
    Data analysis
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Expanded autologous adipose tissue adult mesenchymal stem cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Expanded autologous adipose tissue adult mesenchymal stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5x10E6 cells/kg

    Arm title
    		 Group B
    Arm description
    		 CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2-7 x10E6 CD133+ cells

    Arm title
    		 Group C
    Arm description
    		 Unexpanded autologous bone marrow adult mononuclear stem cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Unexpanded autologous bone marrow adult mononuclear stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150-250 x 10E6 cells

    Arm title
    		 Group D
    Arm description
    		 Conventional treatment
    Arm type
    		 Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group A Group B Group C Group D
    Started
    8
    6
    3
    3
    Completed
    8
    6
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Expanded autologous adipose tissue adult mesenchymal stem cells

    Reporting group title
    Group B
    Reporting group description
    		 CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells

    Reporting group title
    Group C
    Reporting group description
    		 Unexpanded autologous bone marrow adult mononuclear stem cells

    Reporting group title
    Group D
    Reporting group description
    		 Conventional treatment

    Reporting group values
    		 Group A Group B Group C Group D Total
    Number of subjects
    		 8 6 3 3 20
    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
    Units: years
        median (full range (min-max))
    		 64.5 (45 to 77) 61.5 (49 to 73) 73 (70 to 77) 78 (63 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 1 1 6
        Male
    		 6 4 2 2 14
    Cardiovascular disease
    Units: Subjects
        Yes
    		 8 6 3 3 20
        No
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Expanded autologous adipose tissue adult mesenchymal stem cells

    Reporting group title
    Group B
    Reporting group description
    		 CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells

    Reporting group title
    Group C
    Reporting group description
    		 Unexpanded autologous bone marrow adult mononuclear stem cells

    Reporting group title
    Group D
    Reporting group description
    		 Conventional treatment
    Reporting group title
    Group A
    Reporting group description
    		 Expanded autologous adipose tissue adult mesenchymal stem cells

    Reporting group title
    Group B
    Reporting group description
    		 CD133 + Unexpanded Autologous Bone Marrow Adult Mononuclear Stem Cells

    Reporting group title
    Group C
    Reporting group description
    		 Unexpanded autologous bone marrow adult mononuclear stem cells

    Reporting group title
    Group D
    Reporting group description
    		 Conventional treatment

    Primary: Degree of neovascularization (Total tube area)

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    End point title
    		 Degree of neovascularization (Total tube area) [1] [2]
    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
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    8
    6
    3
    Units: TTA
    arithmetic mean (full range (min-max))
        Infusion
    9384.58 (8052.76 to 10716.40)
    7626.42 (6412.81 to 8840.03)
    10143.88 (9782.32 to 10505.43)
        6th month
    8304.88 (7202.91 to 9406.85)
    8557.63 (7616.74 to 9498.51)
    10394.50 (9770.25 to 11018.76)
    No statistical analyses for this end point

    Primary: Degree of neovascularization (branching points)

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    End point title
    		 Degree of neovascularization (branching points) [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [3] - 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
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    8
    6
    3
    Units: Branching points (BP)
    arithmetic mean (full range (min-max))
        Infusion
    13.67 (8.62 to 18.71)
    8.08 (4.00 to 12.16)
    28.75 (26.00 to 31.50)
        6th month
    10.50 (6.21 to 14.79)
    14.13 (10.72 to 17.53)
    14.75 (11.15 to 18.36)
    No statistical analyses for this end point

    Primary: Degree of neovascularization (Segments)

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    End point title
    		 Degree of neovascularization (Segments) [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [5] - 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
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    8
    6
    3
    Units: Segments (S)
    arithmetic mean (full range (min-max))
        Infusion
    238.00 (183.5 to 292.5)
    176.67 (132.15 to 221.18)
    375.88 (347.96 to 403.80)
        6th month
    185.00 (144.73 to 225.28)
    235.88 (191.80 to 279.95)
    264.63 (230.12 to 299.14)
    No statistical analyses for this end point

    Primary: Degree of neovascularization (Total tube length)

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    End point title
    		 Degree of neovascularization (Total tube length) [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [7] - 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
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    8
    6
    3
    Units: Total tube length (TTL)
    arithmetic mean (full range (min-max))
        Infusion
    1953.40 (1586.74 to 2320.06)
    2090.92 (1775.40 to 2406.44)
    2602.69 (2492.12 to 2713.26)
        6th motnh
    2248.28 (1966.72 to 2529.84)
    2382.89 (2124.87 to 2640.90)
    2914.51 (2744.72 to 3084.30)
    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
    All groups
    Reporting group description
    		 -

    Serious adverse events
    		 All groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 19 (42.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Post procedural complication
    Additional description: Admission to ICU after torpid evolution after multinodular goiter surgery
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Ischaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Stroke
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Progressive dyspnea
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Right foot abscess
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 19 (57.89%)
    Injury, poisoning and procedural complications
    Non-drug-eluting stent implantation in a vessel
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Cardiac disorders
    Hypotensive episodes
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    Right sciatica
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Increased leukocytes, neutrophils, and ESR
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Refers moderate pain in lower limbs
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain in both legs and fatigue from being fasting
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Joint pain in the left ankle
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Heaviness in lower limbs
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Occasional pain in right lower limb
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain in lower limbs
    Additional description: Pain in the 4th finger of lower left limb, edema, occasional cramps and stitches at rest
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    Flu
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Aug 2011
    • Update on the procedure for obtaining bone marrow cells, both mononucleated and CD133⁺: • Inclusion of a clinical test in the protocol. The use of Optical Coherence Tomography (OCT) is incorporated in 3 visits for better monitoring of the general condition of the patient.
    01 Apr 2014
    The difficulties of inclusion of patients and development of the trial led the promoter and research team to review the protocol and eliminate those tests from which the necessary information was not obtained to achieve the objectives of the trial. In addition, it was agreed to review the validity of the results of the tests (their expiration), to extend as much as possible the period allowed from their performance to the randomization of patients, thus avoiding deviations from the protocol. For all this, it was necessary to make a new amendment to the protocol This amendment represented a simplified version of the initial protocol, although it maintained the “n” of 48 patients initially expected.

    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.
    Reported in the summary
    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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