<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/NCT02237846</url>
  </required_header>
  <id_info>
    <org_study_id>CNEI-2014-TBS-UCMSCOA-001</org_study_id>
    <nct_id>NCT02237846</nct_id>
  </id_info>
  <brief_title>Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis</brief_title>
  <official_title>Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Translational Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Translational Biosciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once&#xD;
      per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect&#xD;
      in osteoarthritis (OA) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will assess primarily safety and secondary efficacy endpoints of&#xD;
      allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with&#xD;
      OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will&#xD;
      receive IV UC-MSC once per day for 3 consecutive days.&#xD;
&#xD;
      The primary objective of the trial is freedom from treatment associated adverse events at 3&#xD;
      and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline,&#xD;
      and 3 and 12 months post treatment and will be quantified based on the Western Ontario and&#xD;
      McMaster osteoarthritis index (WOMAC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No enrollment&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>3 months and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a change in joint function from baseline WOMAC assessment</measure>
    <time_frame>3 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system</measure>
    <time_frame>3 months and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Intra-articular knee injection of UC-MSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV injection of UC-MSC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human umbilical cord tissue-derived mesenchymal stem cells</intervention_name>
    <arm_group_label>IV injection of UC-MSC</arm_group_label>
    <arm_group_label>Intra-articular knee injection of UC-MSC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent by the subject.&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Ability to understand the planned treatment.&#xD;
&#xD;
          -  Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic&#xD;
             severity, as defined by the modified Kellgren-Lawrence classification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Women of childbearing potential unwilling to use two forms of contraception&#xD;
&#xD;
          -  Cognitively impaired adults.&#xD;
&#xD;
          -  Presence of large meniscal tears (&quot;bucket handle&quot; tears), as detected by clinical&#xD;
             examination or by magnetic resonance imaging.&#xD;
&#xD;
          -  Inflammatory or postinfectious arthritis.&#xD;
&#xD;
          -  More than 5 degrees of varus or valgus deformity.&#xD;
&#xD;
          -  Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral&#xD;
             compartments of the tibiofemoral joint or the patellofemoral compartment) in persons&#xD;
             over 60 years of age.&#xD;
&#xD;
          -  Intraarticular corticosteroid injection within the previous 3 months.&#xD;
&#xD;
          -  A major neurologic deficit.&#xD;
&#xD;
          -  Serious medical illness with a life expectancy of less than 1 year.&#xD;
&#xD;
          -  Prior admission for substance abuse&#xD;
&#xD;
          -  Body Mass Index (BMI) of 40 kg/m2 or greater&#xD;
&#xD;
          -  Patient receiving experimental medication or participating in another clinical study&#xD;
             within 30 days of signing the informed consent&#xD;
&#xD;
          -  In the opinion of the investigator or the sponsor the patient is unsuitable for&#xD;
             cellular therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salomon Dayan, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Stem Cell Instsitute</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>knee</keyword>
  <keyword>stem cells</keyword>
  <keyword>mesenchymal</keyword>
  <keyword>umbilical cord</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>
  <!-- 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/NCT02237846
org study id: CNEI-2014-TBS-UCMSCOA-001
nct id: NCT02237846
lead sponsor: 
has dmc: No
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once
      per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect
      in osteoarthritis (OA) patients.
The proposed study will assess primarily safety and secondary efficacy endpoints of
      allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with
      OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will
      receive IV UC-MSC once per day for 3 consecutive days.

      The primary objective of the trial is freedom from treatment associated adverse events at 3
      and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline,
      and 3 and 12 months post treatment and will be quantified based on the Western Ontario and
      McMaster osteoarthritis index (WOMAC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: 3 months and 12 months
measure: Number of participants with a change in joint function from baseline WOMAC assessment
time frame: 3 months and 12 months
measure: Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system
time frame: 3 months and 12 months
arm group label: Intra-articular knee injection of UC-MSC
arm group type: Active Comparator
description: Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once
arm group label: IV injection of UC-MSC
arm group type: Active Comparator
description: Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days
intervention type: Biological
intervention name: Human umbilical cord tissue-derived mesenchymal stem cells
arm group label: IV injection of UC-MSC
arm group label: Intra-articular knee injection of UC-MSC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Salomon Dayan, MD
role: Principal Investigator
facility: 
country: Panama
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee