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    Summary
    EudraCT Number:2018-000805-22
    Sponsor's Protocol Code Number:A2017SCI03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-000805-22
    A.3Full title of the trial
    A multi-center, double-blind, randomized, placebo-controlled, delayed-start phase II/III study to assess the efficacy and safety of Neuro-Cells in (sub)acute spinal cord injury patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of the effectiveness and safety of an autologous stem cell product (Neuro-Cells) in patients with a (sub)acute spinal cord injury.
    A.3.2Name or abbreviated title of the trial where available
    Stem Cells in Spinal Cord Injury (SCI2)
    A.4.1Sponsor's protocol code numberA2017SCI03
    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 SponsorNeuroplast BV
    B.1.3.4CountryNetherlands
    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 supportNeuroplast BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroplast BV
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressOxfordlaan 55
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 EV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310433885617
    B.5.6E-mailinfo@neuroplast.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/0000002559
    D.3 Description of the IMP
    D.3.1Product nameNeuro-Cells
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal 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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product / EMA / 474951 / 2012 (original name was AMARCELL but this has changed into Neuro-Cells)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntrathecal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Traumatic spinal cord injury
    E.1.1.1Medical condition in easily understood language
    Paralysis of the limbs and/or trunk caused by a trauma of the spinal cord.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to characterize and confirm the safety of intrathecal intervention of Neuro-Cells and to investigate the effect of early administration of Neuro-Cells (between 6 and 10 weeks after the TSCI incident) on the neurological (motor) condition of TSCI patients approx. 6 months after intrathecal intervention.
    This primary objective is intended to answer the question if an early intervention with Neuro-Cells does improve, and to what level, the neurological (motor) condition induced by a TSCI.
    E.2.2Secondary objectives of the trial
    • To investigate the effect of late administration of Neuro-Cells (between 32 and 34 weeks after the TSCI incident) on the neurological (motor) condition of TSCI patients approx. 6 months after intrathecal intervention.
    This secondary objective is intended to answer the question if a later intrathecal intervention with Neuro-Cells does improve, and to what level, the neurological (motor) condition induced by a TSCI.

    • The other secondary objectives in this study are intended to investigate the effect of Neuro-Cells on the autonomic and sensoric neurological dysfunction, daily activity level, quality of life, pain perception, spasticity, use of pain-reducing and spasticity-reducing medication of TSCI patients approximately 6 and respectively 12 months after intrathecal intervention depending on initial treatment assignment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age range: 18 - 65 years
    2. Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization
    3. Randomization can be done within 6-10 weeks after the TSCI incident
    4. Level of injury between C4 to T12
    5. Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed
    E.4Principal exclusion criteria
    1. SCI AIS grade D or E at the start of enrolment
    2. Allergic to mice antibodies and/or iron-dextran
    3. Level of SCI above C4 or below T12
    4. Positive HIV, hepatitis B or C serology
    5. Positive Lues test
    6. Total Nuclear Cell (TNC) count in Bone Marrow sample < 1x109 TNC
    7. Patients suffering from respiratory issues that cannot breathe on their own 24/7
    8. Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis etc.), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator’s discretion
    9. Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti-inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed) (see section 6.8)
    10. Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g., heroin, cocaine, XTC)
    11. Individuals that belong to vulnerable population groups
    12. Females with childbearing potential without using adequate birth control methods (e.g., contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged release), subdermal implantation, vaginal ring or transdermal patches), and/or being pregnant or in the lactation period
    13. Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial
    14. Participants with extreme comorbidity before or after the TSCI
    15. Participants who are unable to comply with the requirements of this clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety endpoint:
    • Safety at approx. 3 months after intrathecal intervention with Neuro-Cells (day 90 for the patients treated 6-8 weeks after the TSCI incident and day 270 for the patients treated at 32-34 weeks after the TSCI incident)
     Physical examination status
    o Following an electronic Case Report Form (e-CRF) checklist in which the physician focusses on the spinal cord (International Standards for Neurological Classification of SCI (ISNCSCI)), the upper and lower respiratory tract, the circulation (pulse and blood pressure) and the liver, spleen and kidneys (enlargement and pressure pain)
     Biochemical changes in blood and urine
    o Measuring biochemical blood variables: red and white blood cell counts, Hb, Ht, platelets, ASAT, ALAT, AP, cholesterol (LDL and HDL), triglycerides, creatinine, urea, sodium, potassium, chloride, calcium, phosphor, bilirubin, total protein and albumin
    o Measuring biochemical urine variables: protein, cells, glucose and sediment

    Adverse events incidences and severity reported during the study (first to last visit)

    Primary efficacy endpoint:
    • Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 2) at 6 months after the intrathecal intervention (day 180) in patients treated with Neuro-Cells 6 to 8 weeks after the TSCI incident as compared to placebo treated patients.

    The SCl-induced neurological (motor) condition is expressed in the International Standards for Neurological Classification of SC (ISNCSCI). The ISNCSCI motor score is an internationally accepted assessment score to describe the disability of a SCI patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, 180 and 360 of the study.
    E.5.2Secondary end point(s)
    Secondary efficacy:
    • Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 5) at 6 months after the intrathecal intervention (day 360) in patients treated with Neuro-Cells 32 to 34 weeks after the TSCI incident as compared to placebo treated patients

    • In patients treated with Neuro-Cells approximately 6-8 weeks after the TSCI, the following secondary endpoints will be studied at days 180 and 360 and compared to the placebo treated patients and the baseline measurements (day 0):
     Increase in ISNCSCI sensory scores (pinprick and light touch)
     Functional outcome using SCIM III assessments (Bluvshtein et al, 2011)
     Pain perception (Widerstrom-Noga et al, 2014) and pain-reducing medication
     Spasticity measurements of the knee and hip flexor and extensor muscles using the modified Ashworth scale (MAS) (Bohannon and Smith, 1987) and actual spasticity-reducing medication
     General wellbeing 3 question items QoL (Charlifue et al, 2012)

    • In patients treated with Neuro-Cells approximately 32-34 weeks after the TSCI, the following secondary endpoints will be studied at days 360 and compared to the baseline measurements (day 0 and day 180):
     Increase in ISNCSCI sensory scores (pinprick and light touch)
     Functional outcome using SCIM III assessments
     Pain perception and pain-reducing medication
     Spasticity measurements of the knee and hip flexor and extensor muscles using the modified Ashworth scale (MAS) and actual spasticity-reducing medication
     General wellbeing 3 question items QoL
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary measures will be studied at days 0, 180 and 360 of the study.
    Improvements in urinary and bowel functions will be studied at days 0 and 360.
    Safety aspects will be studied at study days 90 and 270.
    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) Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Delayed-start protocol
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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
    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 Decision2019-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-07-30
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