<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/NCT03810521</url>
  </required_header>
  <id_info>
    <org_study_id>CLT-OA1</org_study_id>
    <nct_id>NCT03810521</nct_id>
  </id_info>
  <brief_title>Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis</brief_title>
  <acronym>CLT-OA1</acronym>
  <official_title>A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de los Andes, Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de los Andes, Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC&#xD;
      based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC score</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VAS score</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in structural joint assessment by MRI</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>CLT low-dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CLT medium-dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CLT high-dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>umbilical cord derived-mesenchymal stromal cells</intervention_name>
    <description>Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells</description>
    <arm_group_label>CLT high-dose</arm_group_label>
    <arm_group_label>CLT low-dose</arm_group_label>
    <arm_group_label>CLT medium-dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient between 30 and 75 years old&#xD;
&#xD;
          -  Knee-OA Kellgren Lawrence grade I to III&#xD;
&#xD;
          -  Pain density according to visual analogue scale superior or equal to 50 mm&#xD;
&#xD;
          -  Patelar condromalacia grade I to III&#xD;
&#xD;
          -  Stable joint with normal physical exploration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral symptomatic disease&#xD;
&#xD;
          -  Local or systemic infection&#xD;
&#xD;
          -  Neoplasia&#xD;
&#xD;
          -  Immunosuppression state&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Anticoagulant therapy&#xD;
&#xD;
          -  Other types of arthritis&#xD;
&#xD;
          -  Symptomatic disease of hip and/or spine&#xD;
&#xD;
          -  Intra-articular infiltration with steroids in the last 3 months&#xD;
&#xD;
          -  Intra-articular infiltration with hyaluronic acid in the last 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francisco Espinoza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMO</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francisco Espinoza, MD</last_name>
    <phone>56226181008</phone>
    <email>fespinoza@uandes.cl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roberto Bobadilla</last_name>
    <phone>56226181000</phone>
    <email>rbobadilla@c4c.cl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clínica Universidad de los Andes</name>
      <address>
        <city>Santiago</city>
        <state>Xiii</state>
        <zip>7620001</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Matas, MD</last_name>
      <phone>56226181000</phone>
      <email>jmatas@uandes.cl</email>
    </contact>
    <contact_backup>
      <last_name>Eduardo Carrasco, MD</last_name>
      <phone>56226181000</phone>
      <email>ecarrasco@clinicauandes.cl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de los Andes, Chile</investigator_affiliation>
    <investigator_full_name>Francisco Espinoza</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>mesenchymal stromal cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03810521
org study id: CLT-OA1
nct id: NCT03810521
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC
      based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of adverse events
time frame: 6 months
measure: Change in WOMAC score
time frame: 6 months
measure: Change in VAS score
time frame: 6 months
measure: Changes in structural joint assessment by MRI
time frame: 6 months
arm group label: CLT low-dose
arm group type: Experimental
description: Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
arm group label: CLT medium-dose
arm group type: Experimental
description: Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
arm group label: CLT high-dose
arm group type: Experimental
description: Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
intervention type: Biological
intervention name: umbilical cord derived-mesenchymal stromal cells
description: Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
arm group label: CLT high-dose
arm group label: CLT low-dose
arm group label: CLT medium-dose
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Francisco Espinoza, MD
role: Principal Investigator
affiliation: CMO
last name: Francisco Espinoza, MD
phone: 56226181008
email: fespinoza@uandes.cl
last name: Roberto Bobadilla
phone: 56226181000
email: rbobadilla@c4c.cl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Universidad de los Andes, Chile
investigator full name: Francisco Espinoza
investigator title: Associate Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No