<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03778333</url>
  </required_header>
  <id_info>
    <org_study_id>MSC-progressive MS</org_study_id>
    <nct_id>NCT03778333</nct_id>
  </id_info>
  <brief_title>Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden</brief_title>
  <official_title>Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the safety of a single dose of IV infusion of bone-marrow derived autologous&#xD;
      Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label phase 1, single-center, pre-post comparison study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate number of participants with an adverse event related to the treatment.</measure>
    <time_frame>48 weeks</time_frame>
    <description>Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.</measure>
    <time_frame>48 weeks</time_frame>
    <description>Brain MRI examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).</measure>
    <time_frame>48 weeks</time_frame>
    <description>EDSS assessed by neurologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate effect on peripheral blood immune cell populations.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Peripheral blood samples.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Autologous Mesenchymal Stem Cells</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Open label single arm study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous mesenchymal stem cells</intervention_name>
    <description>IV therapy with autologous bone-marrow derived mesenchymal stem cells</description>
    <arm_group_label>Open label single arm study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of MS&#xD;
&#xD;
               1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically&#xD;
                  documented relapse in the past 12 months or ≥2 clinically documented relapses in&#xD;
                  the last 24 months.&#xD;
&#xD;
               2. Secondary progressive MS with clinical progression as evidenced by an increase of&#xD;
                  1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or&#xD;
                  evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.&#xD;
&#xD;
               3. Primary progressive MS with clinical progression as evidenced by an increase of 1&#xD;
                  EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.&#xD;
&#xD;
          2. Age_ 18-65 years&#xD;
&#xD;
          3. Disease duration: 2-20 years&#xD;
&#xD;
          4. EDSS 3,0-7,0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subtype of MS not fulfilling inclusion criteria&#xD;
&#xD;
          2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod,&#xD;
             within the 3 months prior to randomization&#xD;
&#xD;
          3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to&#xD;
             randomization&#xD;
&#xD;
          4. Treatment with corticosteroids within the 30 days prior to randomization&#xD;
&#xD;
          5. Relapse occurred during the 60 days prior to randomization&#xD;
&#xD;
          6. Previous history of a malignancy other than basal cell carcinoma of the skin or&#xD;
             carcinoma in situ that has been in remission for more than one year&#xD;
&#xD;
          7. Severely limited life expectancy by another co-morbid illness&#xD;
&#xD;
          8. Active or chronic severe infection.&#xD;
&#xD;
          9. History of previous diagnosis of myelodysplasia or previous hematologic disease or&#xD;
             current clinically relevant abnormalities of white blood cell counts&#xD;
&#xD;
         10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice&#xD;
             active contraception during the duration of the study)&#xD;
&#xD;
         11. eGFR &lt; 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI&#xD;
             examination.&#xD;
&#xD;
         12. Inability to give written informed consent in accordance with research ethics board&#xD;
             guidelines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karolinska Institute, Karolinska University Hospital Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Institute, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 14, 2015</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Lou Brundin</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Chronic Progressive</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03778333
org study id: MSC-progressive MS
nct id: NCT03778333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To assess the safety of a single dose of IV infusion of bone-marrow derived autologous
      Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label phase 1, single-center, pre-post comparison study
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate number of participants with an adverse event related to the treatment.
time frame: 48 weeks
description: Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.
measure: To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.
time frame: 48 weeks
description: Brain MRI examination
measure: To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).
time frame: 48 weeks
description: EDSS assessed by neurologist.
measure: To evaluate effect on peripheral blood immune cell populations.
time frame: 24 weeks
description: Peripheral blood samples.
arm group label: Open label single arm study
arm group type: Experimental
description: All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.
intervention type: Biological
intervention name: Autologous mesenchymal stem cells
description: IV therapy with autologous bone-marrow derived mesenchymal stem cells
arm group label: Open label single arm study
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Lou Brundin
investigator title: MD, PhD
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Chronic Progressive
mesh term: Sclerosis