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    Summary
    EudraCT Number:2012-003482-18
    Sponsor's Protocol Code Number:RN01-CP-0002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-003482-18
    A.3Full title of the trial
    A Phase II Efficacy Study of Intracerebral CTX0E03 DP In Patients with Stable Paresis of the Arm Following an Ischaemic Stroke.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An effectiveness and safety trial of CTX0E03 Drug Product injected into a patient's brain for the treatment of stable stroke due to reduced blood flow.
    A.3.2Name or abbreviated title of the trial where available
    PISCES II
    A.4.1Sponsor's protocol code numberRN01-CP-0002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorReNeuron Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportReNeuron Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReNeuron Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressPencoed Business Park
    B.5.3.2Town/ cityPencoed, Bridgend
    B.5.3.3Post codeCF35 5HY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442038198400
    B.5.6E-mailinfo@reneuron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCTX0E03 Drug Product (DP)
    D.3.2Product code CTX0E03
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracerebral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCTX0E03 human neural stem cells
    D.3.9.2Current sponsor codeCTX0E03
    D.3.9.3Other descriptive nameCTX0E03 human neural stem cells
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Supratentorial ischaemic stroke
    E.1.1.1Medical condition in easily understood language
    Stroke due to a reduced blood flow to the brain.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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 cm3 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.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of i.c. CTX0E03 DP in restoring upper limb function following an ischaemic stroke using the Action Research Arm Test (ARAT).
    • To assess the efficacy of i.c. CTX0E03 DP in restoring function following an ischaemic stroke using the National Institutes of Health Stroke Scale (NIHSS).
    • To assess the efficacy of i.c. CTX0E03 DP in restoring patient’s functional independence following an ischaemic stroke using the Rankin Focused Assessment (RFA) version of the Modified Rankin Scale (mRS).
    • To assess the efficacy of i.c. CTX0E03 DP in improving patient’s ability to execute activities of daily living following an ischaemic stroke using the Barthel Index (BI).
    • To assess the efficacy of i.c. CTX0E03 DP in sensorimotor recovery of the affected limb following an ischaemic stroke using the Fugl-Meyer Assessment (FMA).
    • To assess the safety and tolerability of i.c. CTX0E03 DP in patients following an ischaemic stroke.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to paresis of the affected arm.
    2. Supratentorial ischaemic stroke.
    3. Male or female.
    4. Age 40 years or more.
    5. Stroke, at time of consent, satisfying the following criteria:
    • Modified NIH Stroke Scale (NIHSS) Motor Arm Score of 2 (some effort against gravity),3 (no movement against gravity) or 4 (no movement) for the paretic arm post ischaemic stroke at visit 1 and 2.
    • Clinical diagnosis of stroke confirmed by physician using neuro-imaging (computerised tomography or magnetic resonance imaging).
    • A Score of 0 or 1 for test 2 of the Action Research Arm Test (Grasp a 2.5 cm3 block and move it from the starting position to the target end position) at visit 1 and 2 post-stroke using the affected arm.
    6. Ability to comprehend verbal commands.
    7. Eligible for neurosurgery, including appropriate anatomical target for cell implantation.
    E.4Principal exclusion criteria
    1. Prior history of stroke resulting in permanent moderate to severe disability (i.e. Rankin Scale greater than 2) (other than the presenting ischaemic stroke).
    2. Stroke due to haemorrhage.
    3. History of neurological or other disease resulting in significant functional impairment of the paretic arm impairing potential ability to pick up, lift and place a 2.5 cm3 block (e.g. Parkinson’s disease, motor neuron disease, arthritis, Dupuytren’s contracture or fixed anatomical abnormality).
    4. Any contraindications to MRI including presence of a cardiac pacemaker (excluding MR-conditional cardiac pacemaker), metal fragments in eye etc.
    5. Uncontrolled blood pressure defined as systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg (patients are only to be excluded if an initial value exceeding these limits is repeated on retesting over several days).
    6. Patient with a severe comorbid disorder, not expected to survive more than 12 months.
    7. Acute cardiovascular events other than the presenting ischaemic stroke (e.g. myocardial infarction, recent coronary intervention for symptomatic cardiac disease) considered by the Investigator or the anaesthetist responsible for the patient to place the patient at increased anaesthetic risk, 3 months prior to planned injection of CTX0E03 DP.
    8. History of malignant disease, (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
    9. Current treatment with tamoxifen.
    10. Patients taking valproate drugs for any indication in whom it is not considered appropriate to discontinue the valproate for a period of one week prior and four weeks post neurosurgery. Patients in whom valproate is switched to an alternative agent during this period may be included.
    11. Requirement for antiplatelets and/or anticoagulants including heparin, warfarin or other anticoagulants/ medication that cannot be interrupted to allow surgery.
    12. Requirement for intermittent (stop/start date from 1-month prior-to and 3 month post- CTX0E03 DP administration) use of oral antispasticity medications (oral antispasticity medications are acceptable if they have been taken regularly for at least one month prior to CTX0E03 DP administration).
    13. A history of uncontolled diabetes e.g. history of hypoglycaemic or hyperglycaemic events requiring hospital admission over previous 6 months.
    14. Females of childbearing potential (FOCBP) (or within 2 years of last menstrual cycle) must have a confirmed negative pregnancy test at time of treatment and agree to use two reliable methods of contraception (e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom) for the duration of this study.
    15. Sexually active males with partners who are FOCBP must be willing to use a reliable method of contraception (e.g. barrier and spermicide or as described above) for the duration of this study.
    16. Considered unlikely to be able to attend for all follow-up visits.
    17. Organ transplant recipient.
    18. In the opinion of the Investigator, sustained consumption of alcohol or drugs at a level likely to be injurious to health.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a minimum 2 point improvement in the ARAT test number 2:
    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 cm3 block and move it from the starting position to the target end position) in the affected arm 3 months after implantation 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months following the single dose drug treatment.
    E.5.2Secondary end point(s)
    • To assess the efficacy of intracranial CTX0E03 DP in restoring upper limb function following an ischaemic stroke using the Action Research Arm Test (ARAT).
    • To assess the efficacy of intracranial CTX0E03 DP in restoring function following an ischaemic stroke using the National Institutes of Health Stroke Scale (NIHSS).
    • To assess the efficacy of intracranial CTX0E03 DP in restoring patient’s functional independence following an ischaemic stroke using the Rankin Focused Assessment (RFA) version of the Modified Rankin Scale (mRS).
    • To assess the efficacy of intracranial CTX0E03 DP in improving patient’s ability to execute activities of daily living following an ischaemic stroke using the Barthel Index (BI).
    • To assess the efficacy of intracranial CTX0E03 DP in sensorimotor recovery of the affected limb following an ischaemic stroke using the Fugl-Meyer Assessment (FMA).
    • To assess the safety and tolerability of intracranial CTX0E03 DP in patients following an ischaemic stroke.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Periodically up to 12 months following the single dose drug treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Witnessed informed consent in the event that the patient is unable to sign informed consent due to paresis of the affected arm.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Where national cancer registries permit patients will be flagged for life-long follow-up for new diagnosis of cancer and survival.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR Stroke Research Network
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation NHS Research Scotland Permissions Coordinating Centre (NRSPCC)
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation National Institute for Social Care and Health Research (NISCHR)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-16
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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
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