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    Summary
    EudraCT Number:2012-000518-13
    Sponsor's Protocol Code Number:2011-398
    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:2012-06-21
    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 number2012-000518-13
    A.3Full title of the trial
    Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Own mesenchymal stem cells for multiple sclerosis patients
    A.3.2Name or abbreviated title of the trial where available
    COMSCIMS
    A.4.1Sponsor's protocol code number2011-398
    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 SponsorProf. Per Soelberg Sørensen
    B.1.3.4CountryDenmark
    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 supportDanish Multiple Sclerosis Society
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Roberto S. Oliveri
    B.5.2Functional name of contact pointCell Therapy Unit, The Blood Bank,
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535452034
    B.5.5Fax number4535390038
    B.5.6E-mailoliveri@rh.dk
    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.2.1.1.1Trade name Mesenchymal stem/stromal cells
    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 (MSCs)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) 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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAutologous MSCs
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    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 assess the effect of intra-venously applied autologous MSCs on cerebral inflammation in multiple sclerosis patients
    E.2.2Secondary objectives of the trial
    To assess secondary endpoints as stated elsewhere
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Inflammatory form of multiple sclerosis (MS)
    a. Relapsing-remitting MS (RRMS)
    b. Secondary progressive MS (SPMS) with attacks within the last year

    2. Age 18-50 yr

    3. Affected by MS 2 to 10 years

    4. Expanded disability status scale (EDSS) 3.0-6.5

    5. Progression, attacks and/or progression on MRI after >= 1 yr on disease modifying treatment demonstrated by at least one of the following criteria:
    a. Increase >=1 EDSS point, if baseline EDSS >= 5.0 or 0.5 EDSS point, if baseline EDSS >=5.5, or quantifiable objective evidence for similar progression
    b. >=1 moderate-severe attack within the last 18 months
    c. >=1 Gadolinium positive lesion (double or triple dose Gd)
    d. >=1 new T2 lesion

    6. Evidence for actual inflammatory aktivity, demonstrated by one of the following:
    a. >=1 moderate-severe attack within the last 18 months
    b. >=1 Gadolinium positive lesion (double or triple dose Gd)
    c. >=1 new T2 lesion
    E.4Principal exclusion criteria
    1. Secondary progressive MS without relapses

    2. Primary progressive MS

    3. <= 3 months since treatment with immunosuppressive agents

    4. <= 1 month since modification of therapy with interferon beta or glatiramer acetate

    5. Glucocorticosteroid therapy within the last 30 days

    6. Attack within past 60 days

    7. Pregnancy (detected by urinary hCG in fertile women) or lactation

    8. Uncertain contraception. Acceptable methods of contraception are: sexual inactivity, surgical sterilization, spiral, p-pill or similar p-patch transdermal contraceptive pill or implant or double barrier method (condom or diaphragm with spermicide cream)

    9. Congestive heart failure (NYHA III / IV), cardiomyopathy, heart rhythm disorder requiring treatment, unstable or severe heart disease (CCS III or IV), severe hypertension (systolic greater than 180, diastolic greater than 110)

    10. Previously demonstrated hematologic disease

    11. Previously demonstrated renal insufficiency

    12. Any medical or psychiatric condition or other circumstance that affects the neurological assessment of the person and thereby affect the study's clarification

    13. Contraindication to MRI with gadolinium contrast (eg pacemakers, metal implants)
    E.5 End points
    E.5.1Primary end point(s)
    Number of Gadolinium positive lesions and / or newly demonstrated or increased T2 lesions (combined unique activity) over a period of 24 weeks after administration of MSCs compared with the control period (24 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after MSCs (or placebo)
    E.5.2Secondary end point(s)
    1. Comparison at 48 weeks between early versus late administration of MSCs by:
    a. Change in CUA (combined unique MRI activity), ie. new or enlarged T2 lesions or Gd positive lesion over a period of 48 weeks after administration of mesenchymal stem cells in the MSC group versus the control group
    b. Change in EDSS or functional systems
    c. Number of relapses over a period of 24 weeks after administration of MSCs in the MSC group versus the control group
    d. Disease-free patients (no relapse, progression or MRI activity) over a period of 24 weeks after administration of MSCs in the MSC group versus the control group

    2. Time to first documented relapse over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo (infusion).
    A relapse is defined as development of new or worsening neurological symptoms and outcome in the absence of fever which lasts more than 48 hours. One documented relapse to be measured, corresponding to an increase of at least 1 point in either pyramidal, cerebellar, brain stem, sensory or visual function system or to an increase of at least ½ point on EDSS. A non-documented attack is one that does not meet the criteria for a confirmed relapse.

    3. Total number of relapses (documented and undocumented) over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    4. The number of attack-free patients over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    5. Change in brain volume (SIENA atrophy measurements) over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    6. The number of new and enlarged T2-weighted lesions over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    7. Volume Change of T2-weighted lesions over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    8. Volume Change of T1-weighted lesions over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    9. Change in EDSS over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.

    10. The number of patients with a worsening in EDSS of 1 point maintained for 13 weeks over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described elsewhere (E.5.2)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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
    Last visit of the last patient
    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 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 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: 25
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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)
    Not different from the expected normal treatment of the condition
    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 Danish Multiple Sclerosis Center
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Danish Research Center for Magnetic Resonance
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-04
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