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    Summary
    EudraCT Number:2017-002456-88
    Sponsor's Protocol Code Number:Stroke34
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-23
    Trial 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2017-002456-88
    A.3Full title of the trial
    STROKE34: randomized controlled phase IIa trial of intra-arterial CD34+ cells in acute ischemic stroke.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STROKE34: clinical trial to evaluate the efficacy of an autotransplant of stem cells (CD34+) administered after an acute ischemic stroke.
    A.3.2Name or abbreviated title of the trial where available
    STROKE34
    A.4.1Sponsor's protocol code numberStroke34
    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 SponsorCENTRO HOSPITALAR E UNIVERSITÁRIO DE COIMBRA, E.P.E
    B.1.3.4CountryPortugal
    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 supportCompete 2020
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Hospitalar e Universitário de Coimbra
    B.5.2Functional name of contact pointJoão Sargento Freitas
    B.5.3 Address:
    B.5.3.1Street AddressPraceta Mota Pinto
    B.5.3.2Town/ cityCoimbra
    B.5.3.3Post code3000-075
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351239400400
    B.5.6E-mailjsargentof@hotmail.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 nameAutotransplant of CD34+ cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAUTOLOGOUS CD34+ CELLS
    D.3.9.3Other descriptive nameAUTOLOGOUS CD34+ CELLS
    D.3.9.4EV Substance CodeSUB176697
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100000000
    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
    Acute ischemic stroke
    E.1.1.1Medical condition in easily understood language
    Acute ischemic stroke
    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 21.1
    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
    The main objective of the trial will be to assess the efficacy of intra-arterial administration of CD34+ cells at two timepoints after acute ischemic stroke. Primary outcome will be infarct volume in MRI performed at 3 months.
    E.2.2Secondary objectives of the trial
    The secondary objectives will include adverse events and multidimensional functional and neurological measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-80 years;
    • Acute hemispheric ischemic stroke attributable to injury within the territory supplied by the Middle Cerebral Artery;
    • Symptomatic arterial territory is recanalyzed;
    • Onset of an acute ischemic stroke that can have full clinical, imagiological and bone marrow collection within seven days after onset. Onset is defined as the time that the subject was last seen in a normal state, or bedtime for unwitnessed strokes occurring during sleep;
    • Readily accessible peripheral venous access blood sampling;
    • Ability to understand the requirements of the study and be willing to provide written informed consent, as evidenced by signature on an informed consent document, agreeing to perform the required assessments. In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative.
    E.4Principal exclusion criteria
    • Patients found delirious, comatose, demented or having any mental impairment that in the investigator’s opinion renders the subject incapable to participate in the study;
    • Neurological or non-neurological comorbidities that in the investigator’s opinion may lead, independent of the current stroke, to further deterioration in the subject’s neurological status during the trial period, or may render the study’s neurological assessments inconclusive for the purpose of evaluating solely the stroke’s effects;
    • Presence of high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke
    • Chronic or active acute inflammatory disease at baseline;
    • Active malignancy, or recent surgery (within the previous 3 months);
    • Premorbid neurological deficits and functional limitations assessed by a premorbid Modified Rankin Scale (mRS) score >2;
    • Premorbid severe hepatic, renal or hematologic diseases;
    • Known pregnancy. Females of childbearing potential will be screened at baseline with urine pregnancy test and positive results will be excluded (the choice of excluding pregnancies is due to the relative contra-indication to MRI in these patients);
    • Contra-indication to MRI.
    • Allergy to contrast agents.
    E.5 End points
    E.5.1Primary end point(s)
    Ischemic stroke volume on MRI performed at three months
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three months after stroke onset.
    E.5.2Secondary end point(s)
    • Hemorrhagic transformation (defined as type 2 parenchymal hemorrhage)
    • Any stroke (ischemic stroke, intracerebral hemorrhage and subarachnoid hemorrahge)
    • Death of any cause
    • Functional outcome at three months: modified Rankin Scale (mRS)
    • Impact of stroke throughout the first three months: Stroke Impact Scale (SIS)
    • Cognitive performance at three months: Montreal Cognitive Assessment scale (MoCA)
    • Functional Independence at three months: Barthel Scale
    • Upper limb Capacity at three months: Stroke Upper Limb Capacity Scale (SULCS)
    • Mood at three months: Hospital Anxiety and Depression Scale (HADS)
    • Quality of life at three months: EuroQol Scale (EQ-5D)
    • Gait speed at three months (10 meters test)
    • Temporo-spacial gait organization at three months (GAITRIte speed)
    • Deglutition at three months: Functional Oral Intake Scale (FOIS)
    • Language: Aphasia Rapid Test (ART)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months after stroke onset.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham procedure: anesthesia of illiac crest followed by anesthesia of groin in the angio suite.
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    In the event of any safety concern regarding the participants, the Data Safety Monitoring Board will make a recommendation to continue, stop, or modify the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    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
    We will include patients in the subacute stage of stroke. In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    The participation in the study will not change in any way the treatment or care of the study participants. The decision on patient care during and after the trial will be taken by the attending physician.
    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 Instituto de Ciências Nucleares Aplicadas à Saúde
    G.4.3.4Network Country Portugal
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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