<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/NCT03822858</url>
  </required_header>
  <id_info>
    <org_study_id>TISCHMS-MSCNP-003</org_study_id>
    <nct_id>NCT03822858</nct_id>
  </id_info>
  <brief_title>Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis</brief_title>
  <official_title>Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tisch Multiple Sclerosis Research Center of New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tisch Multiple Sclerosis Research Center of New York</source>
  <brief_summary>
    <textblock>
      To give expanded access to intrathecal autologous MSC-NP treatment to patients with&#xD;
      progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal MSC-NP injection</intervention_name>
    <description>Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.&#xD;
10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of MS as defined by the McDonald criteria&#xD;
&#xD;
          -  Diagnosis of primary progressive or secondary progressive MS&#xD;
&#xD;
          -  Patients will be 18 years or older&#xD;
&#xD;
          -  Significant disability shown by an Expanded Disability Status Score (EDSS, [5]) ≥4.5&#xD;
             that was not acquired within the last 12 months *(Patients with moderate to severe&#xD;
             cerebellar dysfunction who have an EDSS of &lt;6.5 who are not eligible for our Ph II&#xD;
             Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS&#xD;
             scores are heavily related to muscle strength and not balance or coordination and most&#xD;
             accurately reflect paraparesis. Also there are patients with MS who have disabling&#xD;
             upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not&#xD;
             suitable for the Phase II study but may benefit from this therapy).&#xD;
&#xD;
          -  Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI&#xD;
             and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the&#xD;
             last six months and no significant change in EDSS (1 point or more) in the last 12&#xD;
             months&#xD;
&#xD;
          -  Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial.&#xD;
             For example, patients with EDSS &gt;6.5 or MS symptom onset and/or duration of disease&#xD;
             &gt;15 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients who have had any prior stem cell treatments, including HSCT&#xD;
&#xD;
          -  Pregnant or nursing mothers or any woman intending to become pregnant in the next&#xD;
             three years&#xD;
&#xD;
          -  Use of systemic chemotherapeutic or anti-mitotic medications within three months of&#xD;
             study start date due to the possibility of interference with bone marrow procedure&#xD;
&#xD;
          -  History of central nervous system infection or immunodeficiency syndromes due to&#xD;
             increased risk of CNS infection&#xD;
&#xD;
          -  Patients who are anticipated to have difficultly accessing the intrathecal space&#xD;
             related to scoliosis, obesity, or any other relevant factors determined by the PI.&#xD;
&#xD;
          -  Patients who have not tried available therapies for their progressive MS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Saud A Sadiq, MD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tisch MS Research Center of New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tisch MS Research Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Harris VK, Stark J, Vyshkina T, Blackshear L, Joo G, Stefanova V, Sara G, Sadiq SA. Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis. EBioMedicine. 2018 Mar;29:23-30. doi: 10.1016/j.ebiom.2018.02.002. Epub 2018 Feb 3.</citation>
    <PMID>29449193</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>Neural Progenitors</keyword>
  <keyword>Autologous</keyword>
  <keyword>Bone Marrow</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>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/NCT03822858
org study id: TISCHMS-MSCNP-003
nct id: NCT03822858
lead sponsor: 
To give expanded access to intrathecal autologous MSC-NP treatment to patients with
      progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell
      trial.
expanded access type treatment: Yes
intervention type: Drug
intervention name: Intrathecal MSC-NP injection
description: Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.
10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Saud A Sadiq, MD, FAAN
role: Principal Investigator
affiliation: Tisch MS Research Center of New York
facility: 
country: United States
citation: Harris VK, Stark J, Vyshkina T, Blackshear L, Joo G, Stefanova V, Sara G, Sadiq SA. Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis. EBioMedicine. 2018 Mar;29:23-30. doi: 10.1016/j.ebiom.2018.02.002. Epub 2018 Feb 3.
PMID: 29449193
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis