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    Clinical Trial Results:
    A Phase II Efficacy Study of Intracerebral CTX0E03 DP In Patients with Stable Paresis of the Arm Following an Ischaemic Stroke.

    Summary
    EudraCT number
    		 2012-003482-18
    Trial protocol
    		 GB  
    Global end of trial date
    16 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2019
    First version publication date
    06 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RN01-CP-0002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02117635
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ReNeuron Ltd.
    Sponsor organisation address
    Pencoed Business Park,Pencoed,, Bridgend, United Kingdom, CF35 5HY
    Public contact
    Shaun Stapleton, ReNeuron Ltd., +44 2038198400, shaun-stapleton@reneuron.com
    Scientific contact
    Rick Beckman, ReNeuron Ltd., +44 2038198400, rick-beckman@reneuron.com
    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
    16 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To determine whether a sufficient proportion of patients experience response of their paretic arm following treatment with CTX0E03 DP at a dose level of 20 million cells to justify a subsequent randomised study. o Response will be defined as a minimum improvement of 2 points in test number 2 of the Action Research Arm Test (Grasp a 2.5 cm^3 block and move it from the starting position to the target end position) in the affected arm 3 months after injection of CTX0E03 DP. This would represent an improvement from a pre-treatment state in which the patient was unable to grasp and reposition the block as required to a post-treatment state in which the patient could accomplish the task as specified within 60 seconds and would represent recovery of useful function in a previously paretic arm.
    Protection of trial subjects
    The study protocol, the patient information sheet (PIS) and consent form and all amendments were submitted to all relevant Competent Authorities (CA) and Research Ethics Committees (REC) in accordance with local regulations. Approval was obtained from the REC and regulatory agency prior to study initiation. This study was conducted in accordance with Good Clinical Practice (GCP) as defined by the International Council for Harmonization (ICH), the ethical principles that have their origin in the Declaration of Helsinki and its amendments, and all applicable national and international laws. Prior to enrolment and any screening activities, the study procedures and any known or likely risks were explained to the patients in lay language by the Investigator or designee. Patients were provided with a written PIS and informed consent form (ICF) and were given ample opportunity to enquire about the study. Once the Investigator was assured that the patient understood the commitments of participating in the study, the patient was asked to sign and personally date the ICF in the presence of the Investigator or Sub-investigator. If the patient was not physically able to sign the form, a witness may have signed the consent form on their behalf. Each patient’s consent form was also signed and dated by the Investigator or Subinvestigator. No protocol-specific tests or procedures, that were not part of routine care, were performed prior to informed consent being obtained. All active patients signed an updated ICF if revisions that affected the patients’ safety or decision to participate were made to the ICF during the course of the study. This study was guided by a Data Safety Monitoring Board (DSMB) which included a minimum of one clinician expert in the management of stroke, one neurosurgeon and one medical statistician. The DSMB reviewed all safety data at predetermined intervals during the course of the study.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Jun 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Regulatory reason, Safety
    Long term follow-up duration
    		 100 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total, 41 patients were enrolled from 8 different clinical sites in the UK. Out of the 41 patients enrolled, 23 patients were treated. The first patient was enrolled on 31 July 2014. The last patient visit took place on 16 August 2017.

    Pre-assignment
    Screening details
    		 Of the 41 patients screened, 23 passed screening and were treated in the study. The reasons for screen failure were as follows, in order of importance: Test positive for Human Leucocyte Antigens (HLA) expressed on the CTX0E03 cell line; Withdrawal of consent; Did not meet the entry criteria; Missing record; Other.

    Period 1
    Period 1 title
    D365 Final Analysis (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CTX0E03 DP
    Investigational medicinal product code
    CTX0E03 DP
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intracerebral use
    Dosage and administration details
    CTX0E03 DP is a formulation containing a human neural stem cell line developed by ReNeuron. CTX0E03 DP is an off-white, opaque, sterile suspension. The treatment in this study was an intracerebral implantation of 400 μL CTX0E03 DP at a nominal dose level of 20x10^6 cells in sterile suspension on a single occasion.

    Number of subjects in period 1
    		Treatment arm
    Started
    23
    D90
    23
    Completed
    20
    Not completed
    3
         Death
    1
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    D365 Final Analysis
    Reporting group description
    		 All treated subjects

    Reporting group values
    		 D365 Final Analysis Total
    Number of subjects
    		 23 23
    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)
    		 11 11
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.39 ( 10.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Day 365
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated subjects at Day 365

    Subject analysis set title
    Day 90
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated subjects at Day 90

    Subject analysis set title
    NIHSS UL < 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects with a baseline NIHSS Upper Limb Score of less than 4

    Subject analysis set title
    NIHSS UL = 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects with a baseline NIHSS Upper Limb score of 4

    Subject analysis sets values
    		 Day 365 Day 90 NIHSS UL < 4 NIHSS UL = 4
    Number of subjects
    23
    23
    14
    9
    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)
    11
    11
    9
    2
        From 65-84 years
    12
    12
    5
    7
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.39 ( 10.77 )
    62.39 ( 10.77 )
    57.57 ( 9.43 )
    69.89 ( 8.39 )
    Gender categorical
    Units: Subjects
        Female
    10
    10
    8
    2
        Male
    13
    13
    6
    7

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Subject analysis set title
    Day 365
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated subjects at Day 365

    Subject analysis set title
    Day 90
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All treated subjects at Day 90

    Subject analysis set title
    NIHSS UL < 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects with a baseline NIHSS Upper Limb Score of less than 4

    Subject analysis set title
    NIHSS UL = 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects with a baseline NIHSS Upper Limb score of 4

    Primary: Action Research Arm Test 2 - Minimum improvement of 2 points

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    End point title
    		 Action Research Arm Test 2 - Minimum improvement of 2 points [1]
    End point description
    The primary efficacy endpoint, correlating to useful recovery of function, was defined as the ability to use the previously paretic arm to pick up a 2.5cm^3 block from a table top, lift it and reposition it on a higher surface. This is Action Research Arm Test number 2. A responder is defined as having a minimum improvement of 2 points in test number 2 from baseline. Results are also displayed per baseline NIHSS Upper Limb Score. The % of subjects is presented to the nearest whole number.
    End point type
    Primary
    End point timeframe
    90 Days
    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: The system does not allow for statistical analysis for studies with a single treatment arm.
    End point values
    		 Treatment arm NIHSS UL < 4 NIHSS UL = 4
    Number of subjects analysed
    23
    14
    9
    Units: % of subjects
    number (not applicable)
        Day 90
    4
    7
    0
        Day 365
    15
    25
    0
    No statistical analyses for this end point

    Secondary: National Institutes of Health Stroke Scale - Minimum improvement of 10 points

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    End point title
    		 National Institutes of Health Stroke Scale - Minimum improvement of 10 points
    End point description
    This endpoint is to assess the efficacy of intracranial CTX0E03 DP in restoring function following an ischaemic stroke using the National Institutes of Health Stroke Scale (NIHSS). The NIHSS comprises 11 items, each scored from 0-2/3/4 giving a total of 0 - 42 where lower numbers correspond to better neurological impairment outcomes. A responder is defined as having a minimum improvement of 10 points from baseline.
    End point type
    Secondary
    End point timeframe
    90 Days; 365 Days
    End point values
    		 Day 365 Day 90
    Number of subjects analysed
    20
    23
    Units: No. of subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Barthel Index - Minimum improvement of 9 points

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    End point title
    		 Barthel Index - Minimum improvement of 9 points
    End point description
    This endpoint is to assess the efficacy of intracerebral CTX0E03 DP in improving patient’s ability to execute activities of daily living following an ischaemic stroke using the Barthel Index (BI). The BI comprises 10 items, each scored from 0-10 or 0-15 in intervals of 5 points giving a total of 0 - 100 where higher numbers correspond to better functional outcomes. A responder is defined as having a minimum improvement of 9-points from baseline. Results are also displayed per baseline NIHSS Upper Limb score. The % of subjects is presented to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    90 Days; 365 Days
    End point values
    		 Treatment arm NIHSS UL < 4 NIHSS UL = 4
    Number of subjects analysed
    23
    14
    9
    Units: % of subjects
    number (not applicable)
        Day 90
    35
    21
    56
        Day 365
    40
    25
    63
    No statistical analyses for this end point

    Secondary: Fugl-Meyer Assessment - Minimum improvement of 10 points

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    End point title
    		 Fugl-Meyer Assessment - Minimum improvement of 10 points
    End point description
    This endpoint is to assess the efficacy of intracerebral CTX0E03 DP in sensorimotor recovery of the affected limb restoring function following an ischaemic stroke using the Fugl-Meyer Assessment (FMA). FMA comprises motor assessments for upper extremities (33 tests), lower extremities (17 tests), and sensory assessments (12 tests), giving a total motor and sensory score of 0 - 124, where higher numbers correspond to a better medical outcome. A responder is defined as having a minimum improvement of 10 points from baseline on either Motor Function Upper Extremity Score or Motor Function Lower Extremity Score. The % of subjects is presented to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    90 Days; 365 Days
    End point values
    		 Day 365 Day 90
    Number of subjects analysed
    10
    10
    Units: % of subjects
        number (not applicable)
    30
    40
    No statistical analyses for this end point

    Secondary: modified Rankin Score - Minimum improvement of 1 Grade

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    End point title
    		 modified Rankin Score - Minimum improvement of 1 Grade
    End point description
    The modified Rankin Score (mRS) assessment is a hierarchical score of disability graded from 0-6 where 0 represents no symptoms and 6 represents death. Lower numbers correspond to better disability outcomes. A score of ≤2 is generally accepted to represent functional independence and a score of ≤3 signifies independence in walking. The Focused Assessment tool is a structured interview that improves inter-observer agreement on assigning mRS grades. A responder is defined as a minimum improvement of 1 grade from baseline Results are also displayed per baseline NIHSS Upper Limb score. The % of subjects is presented to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    Day 90; Day 365
    End point values
    		 Treatment arm NIHSS UL < 4 NIHSS UL = 4
    Number of subjects analysed
    23
    14
    9
    Units: % of subjects
    number (not applicable)
        Day 90
    30
    43
    11
        Day 365
    35
    50
    13
    No statistical analyses for this end point

    Secondary: Action Research Arm Test Total Score - Minimum improvement of 6 points

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    End point title
    		 Action Research Arm Test Total Score - Minimum improvement of 6 points
    End point description
    This endpoint was to assess overall improvement in Action Research Arm Test (ARAT) total score. The ARAT comprises 19 test items, each scored from 0-3 giving a total of 0 - 57 where higher numbers correspond to better functional outcomes. A responder is defined as a minimum improvement of ARAT total score of 6 points from baseline. Results are also displayed per baseline NIHSS Upper Limb score. The % of subjects is presented to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    Day 90; Day 365
    End point values
    		 Treatment arm NIHSS UL < 4 NIHSS UL = 4
    Number of subjects analysed
    23
    14
    9
    Units: % of subjects
    number (not applicable)
        Day 90
    13
    21
    0
        Day 365
    25
    42
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 365
    Adverse event reporting additional description
    This report provides safety data for all 23 treated patients. Safety data are available through the completion of the Day 365 study completion visit for 20/23 (86.96%) patients. One patient died (sepsis of unknown origin), and so was withdrawn from the study prematurely and 2 patients were lost-to follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Treatment Group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 23 (47.83%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Investigations
    HLA marker study positive
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertonia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 23 (91.30%)
    Injury, poisoning and procedural complications
    Procedural hypotension
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Fall
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    4
    Procedural headache
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Wound complication
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Wound secretion
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Joint injury
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    2
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 23 (26.09%)
         occurrences all number
    7
    Aphasia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Balance disorder
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Migraine with aura
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences all number
    6
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences all number
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Renal and urinary disorders
    Hypertonic bladder
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Musculoskeletal pain
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Arthralgia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
         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
    01 Aug 2014
    Protocol version 4.0, dated 09 Jul 2014. Changes to inclusion/exclusion criteria and trial evaluation schedule.
    26 Nov 2014
    Protocol version 6.0, dated 21-Nov-2014 Clarification regarding the use of antiplatelet and anticoagulant therapy prior to surgery. Expanding the definition of exclusion criterion #8 (relating to patients with cardiovascular events prior to the planned injection of CTX0E03 DP).
    15 May 2015
    Protocol version 7.0, dated 15-Apr-2015 Changes to qualifying stroke functional assessments Changes to inclusion/exclusion criteria Re-screening of potential eligible subjects added to protocol
    11 Apr 2016
    Protocol version 8.0, dated 09-Mar-2016 Timing of primary endpoint brought forward Additional efficacy measure is proposed as a secondary endpoint - Fugl-Meyer Assessment (FMA) Study design modification to a single cohort design Include females of childbearing potential Revised AE/SAE, follow-up and pregnancy reporting wording

    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.
    NA
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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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