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    Summary
    EudraCT Number:2014-001912-20
    Sponsor's Protocol Code Number:48431
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001912-20
    A.3Full title of the trial
    Adult mesenchymal stem cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stem cells IntraNasally)
    Volwassen mesenchymale stamceltherapie voor regeneratie van het neonatale brein: de PASSIoN trial (Perinatale Arteriële Stroke behandeld met Stamcellen IntraNasaal)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mesenchymal stem cells for neonatal stroke
    Mesenchymale stamceltherapie voor neonatale herseninfarcten
    A.3.2Name or abbreviated title of the trial where available
    PASSIoN
    PASSIoN
    A.4.1Sponsor's protocol code number48431
    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 SponsorUniversity Medical Center Utrecht, The Netherlands
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht, The Netherlands
    B.5.2Functional name of contact pointHead of Department of Neonatology
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6 3584AB
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3485 AB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887554545
    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 namemesenchymale stem cells
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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
    Perinatal arterial Ischemic Stroke (PAIS)
    Perinataal arterieel ischemisch herseninfarct
    E.1.1.1Medical condition in easily understood language
    neonatal stroke
    herseninfarct bij pasgeborene
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study will investigate whether bone marrow-derived allogeneic MSCs, as administered by the nasal route, can induce the formation of neuronal tissue and restore brain function in neonates who suffered from perinatal arterial ischemic stroke (PAIS) compared to a matched group of historic untreated controls. The ultimate goals of the present study is therefore to develop a therapy using adult human allogenic MSCs to reduce or even to prevent the lifelong consequences of PAIS-related brain damage in this group of term newborns.
    Deze studie zal onderzoeken of volwassen allogene MSC uit beenmerg, toegediende via de nasale route, de formatie van neuronaal weefsel kan induceren en zal zorgen voor het herstellen van hersenfunctie van neonaten die een perinataal arterieel ischemisch herseninfarct hebben doorgemaakt, vergeleken met gematchte historische niet-MSC behandelde PAIS patienten. Het einddoel van deze studie is dan ook om een therapie te ontwikkelen met volwassen allogene MSCs om de levenslange negatieve gevolgen van PAIS-gerelateerde hersenschade substantieel te verminderen.
    E.2.2Secondary objectives of the trial
    Not applicable
    niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - (Near-)Term infants, ≥36+0 weeks of gestation, admitted to one of the Dutch NICUs, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms.
    - PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery
    - Written informed consent from custodial parent(s)
    - A terme pasgeborenen, geboren na een zwangerschapsduur van ≥36+0 weken, opgenomen in een van de Nederlandse NICUs, gediagnosticeerd met PAIS binnen 3 dagen na klinische presentatie
    - PAIS is gekarakteriseerd als een voornamelijk unilaterale lesie in het stroomgebied van de arteria cerebri media
    - Ouders hebben schirftelijk informed consent gegeven
    E.4Principal exclusion criteria
    - Any proven or suspected congenital anomaly, chromosomal disorder, metabolic disorder.
    - Presence of an infection of the central nervous system.
    - No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
    - Bewezen of verdenken op congenitale afwijking, chromosomale afwijking of metabole stoornis.
    - Aanwezigheid van een infectie aan het centrale zenuwstelsel.
    - Geen realistische levensverwachten (bijvoorbeeld door ernstige hersenschade), zoals beoordeeld door behandelend arts
    E.5 End points
    E.5.1Primary end point(s)
    Our primary objective is to determine if MSC treatment reduces brain damage, which will be measured on one hand by the change in lesion size and brain growth between the time of onset of the insult and 3 months of age and on the other hand by change of reorganisation of the sensorimotor cortex after neonatal stroke. Change in lesion size and brain growth will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within 3 days after clinical presentation and at 3 months of age. We will use post-processing fibre-tracking programs on diffusion tension imaging (DTI) to detect whether MSC treatment stimulates reorganization of the sensorimotor cortex
    Onze primaire uitkomstmaat is om te bepalen of MSC-therapie hersenschade redueert, wat aan de ene kant gemeten zal worden door de verandering in infarctgroote en hersengroei te meten tussen het moment van optreden van het infarct en de leeftijd van 3 maanden, en aan de andere kant door verandering in reoganisatie van de sensorimotore cortex na neonatale stroke. Volumeveranderingen en hersengroei zullen worden geschat met behulp van geavanceerde volumetrische MRI technieken, welke worden uitgevoerd binnen 3 dagen na klinische presentatie en op de leeftijd van 3 maanden. Post-processing fibre-tracking programma's op diffusion tensor imaging (DTI) zullen worden gebruikt om te zien of MSC-therapie reorganisatie van de sensorimotore cortex stimuleert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 months of age
    op de leeftijd van 3 maanden
    E.5.2Secondary end point(s)
    Bayley scales (BSID-III scales: Mental development index (NDI) and psychomotor index (PDI)
    Bayley scales (BSID-III scales: Mental development index (NDI) en psychomotor index (PDI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 2-years of age
    op leeftijd van 2 jaar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.4Number of treatment arms in the trial20
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 20
    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) No
    F.1.3Elderly (>=65 years) No
    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
    neonates in first week of life
    pasgeborenen in eerste week
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-21
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