<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/NCT03788265</url>
  </required_header>
  <id_info>
    <org_study_id>lipo-knee OA-dxs</org_study_id>
    <nct_id>NCT03788265</nct_id>
  </id_info>
  <brief_title>Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis</brief_title>
  <official_title>Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <brief_summary>
    <textblock>
      Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability,&#xD;
      reduced range of motion, and functional limitations. Current treatment has various&#xD;
      limitations so that alternative options to restore function and alleviate joint pain, with&#xD;
      the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells&#xD;
      (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory&#xD;
      issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose&#xD;
      tissue through mild mechanical force. This procedure is enzyme free and requires no clonal&#xD;
      expansion or manipulation. The goal of this study is to evaluate the possible benefits of&#xD;
      reduced joint pain and increased joint functionality in patients with knee osteoarthritis&#xD;
      after the injection of Lipogems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>N/A</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>Change in Visual Analog Pain Scale (VAS) Over Time</measure>
    <time_frame>Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to &quot;no pain&quot; and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the knee injury and osteoarthritis score (KOOS) Over Time</measure>
    <time_frame>Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipogems</intervention_name>
    <description>harvest and inject micro-fragment adipose tissue</description>
    <arm_group_label>injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of eighteen or older&#xD;
&#xD;
          -  Diagnosis of symptomatic knee osteoarthritis&#xD;
&#xD;
          -  Radiographic evidence of knee osteoarthritis&#xD;
&#xD;
          -  Failure of conservative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with any intra-articular knee injection within 8 weeks before surgery&#xD;
&#xD;
          -  Any disease or condition potential to interfere study outcome&#xD;
&#xD;
          -  Under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xuesong Dai, MD., PhD</last_name>
    <phone>+8687783777</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Second affiliated hospital, school of medicine, Zhejiang Uni.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310058</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xuesong Dai</last_name>
      <phone>+8687783777</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03788265
org study id: lipo-knee OA-dxs
nct id: NCT03788265
lead sponsor: 
Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability,
      reduced range of motion, and functional limitations. Current treatment has various
      limitations so that alternative options to restore function and alleviate joint pain, with
      the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells
      (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory
      issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose
      tissue through mild mechanical force. This procedure is enzyme free and requires no clonal
      expansion or manipulation. The goal of this study is to evaluate the possible benefits of
      reduced joint pain and increased joint functionality in patients with knee osteoarthritis
      after the injection of Lipogems.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Visual Analog Pain Scale (VAS) Over Time
time frame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
description: Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
measure: Change in the knee injury and osteoarthritis score (KOOS) Over Time
time frame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
description: Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.
arm group label: injection
arm group type: Experimental
intervention type: Device
intervention name: Lipogems
description: harvest and inject micro-fragment adipose tissue
arm group label: injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xuesong Dai, MD., PhD
phone: +8687783777
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee