<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/NCT02966951</url>
  </required_header>
  <id_info>
    <org_study_id>ATKneeUJCTC</org_study_id>
    <nct_id>NCT02966951</nct_id>
  </id_info>
  <brief_title>Use of Adipose Tissue Derived Mesenchymal Stem Cells for Knee Osteoarthrosis</brief_title>
  <official_title>Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Adipose Tissue Derived Mesenchymal Stem Cells (ATMSC) for Advanced Stage III and IV KOA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanan Jafar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</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>
      Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed&#xD;
      with Knee osteoarthrosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according&#xD;
      to specific inclusion and exclusion criteria. These patients will be injected with Adipose&#xD;
      Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment,&#xD;
      laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the safety and tolerability of the intra articular injection</measure>
    <time_frame>Time Frame: 6 months</time_frame>
    <description>patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the efficacy of intra-articular injection of ATMSC</measure>
    <time_frame>12 months</time_frame>
    <description>The efficacy of the intra-articular injection of ATMSC will be assessed by Magnetic Resonance Imaging (MRI).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Knee Osteoarthrosis</condition>
  <arm_group>
    <arm_group_label>adipose tissue mesenchymal stem cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adipose tissue derived mesenchymal stem cell</intervention_name>
    <description>Intra-articular adipose tissue derived mesenchymal stem cell injection.</description>
    <arm_group_label>adipose tissue mesenchymal stem cell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Severe KOA stage III or IV by Laurance &amp; Kellgren staging as judged by Posterioranterior&#xD;
        (PA) Xray of the knee joint.&#xD;
&#xD;
        Willing to participate by signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sublaxation beyond 20 degrees of the bones of the knee joint&#xD;
&#xD;
          -  Oral anticoagulants or heparin therapy&#xD;
&#xD;
          -  Heart failure or arrhythmia&#xD;
&#xD;
          -  Body Mass Index &gt; 35&#xD;
&#xD;
          -  Uncontrolled Diabetes Mellitus.&#xD;
&#xD;
          -  Evidence of Infectious Diseases.&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than&#xD;
             3000.&#xD;
&#xD;
          -  Unreliable patients&#xD;
&#xD;
          -  Non-resident in Jordan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdallah Awidi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cell Therapy Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hanan Jafar, PhD</last_name>
    <phone>00962798871087</phone>
    <email>hanan.jafar@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cell Therapy Center</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdalla Awidi, MD</last_name>
      <phone>0096265355000</phone>
      <email>abdalla.awidi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Hanan Jafar</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>osteoarthrosis</keyword>
  <keyword>knee</keyword>
  <keyword>adipose tissue</keyword>
  <keyword>stem cells</keyword>
  <keyword>cell therapy</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>Undecided</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/NCT02966951
org study id: ATKneeUJCTC
nct id: NCT02966951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed
      with Knee osteoarthrosis
Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according
      to specific inclusion and exclusion criteria. These patients will be injected with Adipose
      Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment,
      laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of the safety and tolerability of the intra articular injection
time frame: Time Frame: 6 months
description: patients will be monitored for any adverse events resulting from the intraarticular injection of ATMSC
measure: Assessment of the efficacy of intra-articular injection of ATMSC
time frame: 12 months
description: The efficacy of the intra-articular injection of ATMSC will be assessed by Magnetic Resonance Imaging (MRI).
arm group label: adipose tissue mesenchymal stem cell
arm group type: Experimental
description: Intra-articular adipose tissue derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of ATMSC in each dose
intervention type: Biological
intervention name: Adipose tissue derived mesenchymal stem cell
description: Intra-articular adipose tissue derived mesenchymal stem cell injection.
arm group label: adipose tissue mesenchymal stem cell
criteria: 
gender: All
minimum age: 42 Years
maximum age: 75 Years
healthy volunteers: No
last name: Abdallah Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
last name: Hanan Jafar, PhD
phone: 00962798871087
email: hanan.jafar@gmail.com
facility: 
status: Recruiting
contact: 
country: Jordan
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Hanan Jafar
investigator title: Researcher
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided