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    Summary
    EudraCT Number:2020-002373-95
    Sponsor's Protocol Code Number:270682
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-08-24
    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 ConcernedNorway - NOMA
    A.2EudraCT number2020-002373-95
    A.3Full title of the trial
    Study of Mesenchymal Autologous stem cells as Regenerative Treatment for Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the regenerative effect of mesenchymal stem cell treatment in patients with multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    SMART-MS
    A.4.1Sponsor's protocol code number270682
    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 SponsorHaukeland University Hospital
    B.1.3.4CountryNorway
    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 supportHaukeland University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversity of Bergen
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversity Hospital Ulm
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAkershus University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSt.Olav University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversity Hospital of North Norway
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportKLINBEFORSK
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHaukeland University Hospital
    B.5.2Functional name of contact pointDepartment of Neurology
    B.5.3 Address:
    B.5.3.1Street AddressJonas Lies vei 65
    B.5.3.2Town/ cityBergen
    B.5.3.3Post code5021
    B.5.3.4CountryNorway
    B.5.4Telephone number004755975000
    B.5.6E-mailechr@helse-bergen.no
    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 nameMesenchymal stem cells
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    Multiple sclerosis (MS)
    E.1.1.1Medical condition in easily understood language
    Primary or secondary progressive MS
    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
    To investigate neuroregenerative efficacy of autologous mesenchymal stem cell treatment in patients with progressive MS as measured by neurophysiological parameters
    E.2.2Secondary objectives of the trial
    To investigate neuroregenerative efficacy, safety and feasibilty of autologous mesenchymal stem cell treatment in patients with progressive MS as measured by neurophysiological, radiological, ophtalmological and clinical parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 to ≤55, both genders
    • Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS (1)
    • An EDSS score of 4 to 7
    • Disease duration 2 - 18 years
    E.4Principal exclusion criteria
    • Treatment with cytotoxic medications during the last 3 months prior to inclusion
    • Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment
    • Any active or chronic infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening
    • Current immunomodulatory/immunosuppressive treatment
    • Immunomodulatory/immunosuppressive treatment within 6 months prior to inclusion. This includes, but is not restricted to treatment with natalizumab, fingolimod, dimetylfumurat, glatiramer acetate, interferon beta medications, teriflunomide, and siponimod.
    • Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion
    • Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion
    • Treatment with glucocorticoids or ACTH within three months prior to start of inclusion
    • Having experienced an MS relapse within 2 years prior to study inclusion
    • History of malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year, within the last 10 years
    • Severely limited live expectancy by another co-morbid illness
    • History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts
    • Immunocompromised patients
    • Estimated glomerular filtration rate >60 ml/min/1.73 m2 or known renal failure
    • Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment
    • Platelet (thrombocyte) count < 100 x 10*9/L
    • Participation in another experimental clinical study with administration of another IMP within the preceding 12 months
    • Contraindications to MRI
    • Prior or current major depression
    • Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
    • Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation
    • Known hypersensitivity against paracetamol, codein or xylocain
    • Diagnosis or strong suspicion of polyneuropathy
    • Prior or current alcohol or drug dependencies
    • Inability to give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    •Difference in combined evoked potentials (CEP; visual evoked potentials (VEP) + somatosensoric evoked potentials (SEP) + motor evoked potentials (MEP)) at 6 months (arm A vs. arm B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    • Evaluation of number and nature of adverse events
    • Difference in CEP at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in VEP at 6 months (arm A vs. arm B)
    • Difference in VEP at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in SEP at 6 months (arm A vs. arm B)
    • Difference in SEP at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in MEP at 6 months (arm A vs. arm B)
    • Difference in MEP at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in EDSS at 6 months (arm A vs. arm B)
    • Difference in EDSS at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in MRI T2-weighted hyperintense lesion volume at 6 months (arm A vs. arm B)
    • Difference in MRI T2-weighted hyperintense lesion volume at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in MRI T1-weighted hypointense lesion volume at 6 months (arm A vs. arm B)
    • Difference in MRI T1-weighted hypointense lesion volume at 6 months (study treatment 1 vs. study treatment 2)
    • Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 6 months (arm A vs. arm B)
    • Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 12 months (study treatment 1 vs. study treatment 2)
    • Difference in retinal thickness measured with OCT at 6 months (arm A vs. arm B)
    • Difference in retinal thickness measured with OCT at 12 months (study treatment 1 vs study treatment 2)
    • Difference in brain volume at 6 months (arm A vs. arm B)
    • Difference in brain volume at 6 months (study treatment 1 vs. study treatment 2)
    • Difference in Nine-Hole-Peg Test (9-HPT) score at 6 months (arm A vs. arm B)
    • Difference in Nine-Hole-Peg Test (9-HPT) score at 6 months (study treatment 1 vs. study treatment 2)
    • Difference in Timed 25 Foot Walk (T25FW) score at 6 months (arm A vs. arm B)
    • Difference in Timed 25 Foot Walk (T25FW) score at 6 months (study treatment 1 vs. study treatment 2)
    • Difference in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), European Quality of Life 5 dimensions (EQ-5D-5L), Multiple Sclerosis Impact Scale (MSIS) and Fatigue severity scale (FSS) score at 6 months (arm A vs. arm B)
    • Difference in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), European Quality of Life 5 dimensions (EQ-5D-5L), Multiple Sclerosis Impact Scale (MSIS) and Fatigue severity scale (FSS) score at 12 months (study treatment 1 vs. study treatment 2)
    • Intraindividual CEP (longitudinal) between study treatment 1 vs. study treatment 2 in each patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    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 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 Yes
    E.8.1.7Other No
    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 trial2
    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 concerned4
    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 years3
    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: 18
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    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)
    Standard operating procedures for these patients
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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