<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/NCT03014401</url>
  </required_header>
  <id_info>
    <org_study_id>19-2893</org_study_id>
    <nct_id>NCT03014401</nct_id>
  </id_info>
  <brief_title>The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis</brief_title>
  <official_title>The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the clinical and functional outcomes of patients with&#xD;
      mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:&#xD;
&#xD;
        1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with&#xD;
           standard arthroscopic treatment consisting of: partial meniscectomy, cartilage&#xD;
           stabilization, loose body removal and selective synovectomy.&#xD;
&#xD;
        2. Standard arthroscopic treatment (above) without cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may&#xD;
      differentiate into chondrocytes, promote endogenous tissue repair, and have potent&#xD;
      anti-inflammatory properties.&#xD;
&#xD;
      Early studies show promising clinical results using ADSCs to treat patients with&#xD;
      osteoarthritis, but no clinical trials have been completed comparing cellular therapy to&#xD;
      standard arthroscopic treatment.&#xD;
&#xD;
      The investigators aim to determine whether ADSC transplantation as adjuvant therapy in&#xD;
      patients with arthroscopic findings of mild to moderate arthritis will result in improved&#xD;
      clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery</measure>
    <time_frame>The study will end after 24 month follow-up is completed in all participants.</time_frame>
    <description>Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tegner score</measure>
    <time_frame>6, 12, 24 months</time_frame>
    <description>Patient reported outcomes measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lysholm score</measure>
    <time_frame>6, 12, 24 months</time_frame>
    <description>Patient reported outcomes measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VR-12</measure>
    <time_frame>6, 12, 24 months</time_frame>
    <description>Patient reported outcomes measures</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MRI scans -</measure>
    <time_frame>1, 12, 24 months</time_frame>
    <description>Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">29</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Stem Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic debridement with stem cell transplantation</intervention_name>
    <description>Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.</description>
    <arm_group_label>Stem Cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic debridement only</intervention_name>
    <description>standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 35 and 70 years-old&#xD;
&#xD;
          -  Patient is scheduled to undergo one or a combination of the following procedures:&#xD;
&#xD;
               -  Meniscal debridement or partial menisectomy&#xD;
&#xD;
               -  Meniscal repair that does not necessitate a different postoperative protocol from&#xD;
                  meniscal debridement or partial menisectomy&#xD;
&#xD;
               -  Removal of loose bodies&#xD;
&#xD;
               -  Chondroplasty&#xD;
&#xD;
               -  Synovectomy&#xD;
&#xD;
               -  Soft tissue releases for flexion or extension contracture.&#xD;
&#xD;
          -  Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral&#xD;
             femoral condyle (Kellgren-Lawrence Grade 2 or 3)&#xD;
&#xD;
          -  &lt; 6 months of knee pain or &lt; 6 months of a significant exacerbation of existing knee&#xD;
             pain&#xD;
&#xD;
          -  Physical examination findings consistent with the proposed surgical procedure.&#xD;
&#xD;
          -  Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy&#xD;
             and trial of anti-inflammatory medications, with or without concomitant bracing and/or&#xD;
             injections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 35 or &gt; 70 years old&#xD;
&#xD;
          -  Radiographs demonstrating either no, little or severe osteoarthritis&#xD;
             (Kellgren-Lawrence Grade 0, 1 or 4)&#xD;
&#xD;
          -  Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)&#xD;
&#xD;
          -  Patient scheduled to undergo any concomitant surgical procedures with the exception&#xD;
             of:&#xD;
&#xD;
               -  Meniscal debridement or partial menisectomy&#xD;
&#xD;
               -  Meniscal repair that does not necessitate a different postoperative protocol from&#xD;
                  meniscal debridement or partial menisectomy&#xD;
&#xD;
               -  Removal of loose bodies&#xD;
&#xD;
               -  Chondroplasty&#xD;
&#xD;
               -  Synovectomy&#xD;
&#xD;
               -  Soft tissue releases for flexion or extension contracture&#xD;
&#xD;
          -  Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture,&#xD;
             Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant&#xD;
&#xD;
          -  Previous arthroscopy within 1 year&#xD;
&#xD;
          -  Subchondral edema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason L Dragoo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado - Anschutz Medical Campus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seth L Sherman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Veronica Butler</last_name>
    <phone>(720)872-0112</phone>
    <email>dragoo.lab@ucdenver.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kaitie Whitney</last_name>
    <phone>(720)872-0112</phone>
    <email>dragoo.lab@ucdenver.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kerlan Jobe Orthopedic Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jasmine Galloway, B.S.</last_name>
      <phone>310-829-2663</phone>
      <email>jasmine.galloway@cskerlanjobe.org</email>
    </contact>
    <investigator>
      <last_name>Burt Mandelbaum, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UC Health Steadman Hawkins Clinic - Denver Inverness</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Veronica Butler</last_name>
      <phone>720-872-0112</phone>
      <email>dragoo.lab@ucdenver.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kaitie Whitney</last_name>
      <phone>(720)872-0112</phone>
      <email>dragoo.lab@ucdenver.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stem cell</keyword>
  <keyword>knee pain</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>arthritis</keyword>
  <keyword>ADSC</keyword>
  <keyword>fat stem cell</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/NCT03014401
org study id: 19-2893
nct id: NCT03014401
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the clinical and functional outcomes of patients with
      mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:

        1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with
           standard arthroscopic treatment consisting of: partial meniscectomy, cartilage
           stabilization, loose body removal and selective synovectomy.

        2. Standard arthroscopic treatment (above) without cell transplant.
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may
      differentiate into chondrocytes, promote endogenous tissue repair, and have potent
      anti-inflammatory properties.

      Early studies show promising clinical results using ADSCs to treat patients with
      osteoarthritis, but no clinical trials have been completed comparing cellular therapy to
      standard arthroscopic treatment.

      The investigators aim to determine whether ADSC transplantation as adjuvant therapy in
      patients with arthroscopic findings of mild to moderate arthritis will result in improved
      clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
time frame: The study will end after 24 month follow-up is completed in all participants.
description: Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
measure: Tegner score
time frame: 6, 12, 24 months
description: Patient reported outcomes measures
measure: Lysholm score
time frame: 6, 12, 24 months
description: Patient reported outcomes measures
measure: VR-12
time frame: 6, 12, 24 months
description: Patient reported outcomes measures
measure: MRI scans -
time frame: 1, 12, 24 months
description: Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p
arm group label: Stem Cells
arm group type: Experimental
description: Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
arm group label: Placebo
arm group type: Active Comparator
description: Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
intervention type: Procedure
intervention name: Arthroscopic debridement with stem cell transplantation
description: Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
arm group label: Stem Cells
intervention type: Procedure
intervention name: Arthroscopic debridement only
description: standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
arm group label: Placebo
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jason L Dragoo, MD
role: Principal Investigator
affiliation: University of Colorado - Anschutz Medical Campus
last name: Seth L Sherman, MD
role: Principal Investigator
affiliation: Stanford University
last name: Veronica Butler
phone: (720)872-0112
email: dragoo.lab@ucdenver.edu
last name: Kaitie Whitney
phone: (720)872-0112
email: dragoo.lab@ucdenver.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No