<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/NCT04440189</url>
  </required_header>
  <id_info>
    <org_study_id>GIDOA-03</org_study_id>
    <nct_id>NCT04440189</nct_id>
  </id_info>
  <brief_title>Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis</brief_title>
  <official_title>Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GID BIO, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GID BIO, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a pivotal study to evaluate the efficacy and safety of a single injection of&#xD;
      autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of&#xD;
      pain with concomitant improvement in function associated with osteoarthritis of the knee&#xD;
      joint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, placebo controlled, parallel groups, double blind,&#xD;
      multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will&#xD;
      be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose&#xD;
      tissue (experimental).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <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>Western Ontario and McMaster Universities Arthritis Index</measure>
    <time_frame>6 months</time_frame>
    <description>The WOMAC is a self-administered questionnaire consisting of 14 items divided into 3 subscales, pain, stiffness and function. The primary efficacy will be achieved if the SVF dose group is shown to have a clinically meaningful improvement in pain and function at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The overall WOMAC score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Summary of device, treatment and procedure related adverse event rates and severity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive an injection of Lactated Ringers in their index knee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stromal Vascular Fraction (SVF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive an injection of Stromal Vascular Fraction in their index knee</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GID SVF-2 Device System</intervention_name>
    <description>The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Stromal Vascular Fraction (SVF)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Bilateral or unilateral knee osteoarthritis as diagnosed on pre-op MRI using the&#xD;
             Outerbridge Cartilage Classification as Grade II, Grade III, or Grade IV with full&#xD;
             thickness lesion of the articular cartilage is less than 2.5 cm in any direction&#xD;
&#xD;
          2. Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray&#xD;
&#xD;
          3. Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20&#xD;
             total points)&#xD;
&#xD;
          4. Study Subjects must be willing to voluntarily give written Informed Consent to&#xD;
             participate in the study and sign the Health Insurance Portability and Accountability&#xD;
             Act (HIPAA) authorization before any study procedures are performed&#xD;
&#xD;
          5. Males and females 35-85 years old&#xD;
&#xD;
          6. Subjects with BMI ≥22 and ≤ 37&#xD;
&#xD;
          7. Subjects must speak, read and understand English&#xD;
&#xD;
          8. Subjects must be able to return for multiple follow-up visits&#xD;
&#xD;
          9. Subjects must have failed at least two conservative therapies for treatment of knee OA&#xD;
             within the last 24 months (2 years), with one or more of the failed conservative&#xD;
             therapies being from a-f:&#xD;
&#xD;
               1. Physical Therapy: 6 week course of treatment&#xD;
&#xD;
               2. Exercise Therapy: 6 week course of treatment&#xD;
&#xD;
               3. Viscosupplementation injection in the knee for OA pain&#xD;
&#xD;
               4. Steroid injection in the knee for OA pain&#xD;
&#xD;
               5. Platelet-Rich Plasma (PRP) injection in the knee for OA pain&#xD;
&#xD;
               6. Arthroscopic surgery including microfracture and/or debridement&#xD;
&#xD;
               7. Braces or other support devices: therapy tried for at least 2 weeks&#xD;
&#xD;
               8. Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA:&#xD;
                  therapy tried for at least 2 weeks&#xD;
&#xD;
               9. Prescription pain medication: therapy tried for at least 1 weeks&#xD;
&#xD;
              10. Modification of Activities of Daily Living (ADL): therapy tried for at least 2&#xD;
                  weeks&#xD;
&#xD;
              11. Topical applications to the knee for OA pain: therapy tried for at least 2 weeks&#xD;
&#xD;
              12. Supplements including glucosamine sulfate and chondroitin sulfate: therapy tried&#xD;
                  for at least 4 weeks&#xD;
&#xD;
              13. Ice/Heat regimen: therapy tried for at least 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects whose knee pain is caused by:&#xD;
&#xD;
             i. unstable meniscal root tears or locked bucket handle meniscal tears ii. displaced&#xD;
             meniscus tear iii. osteo chondritis dissecans iv. parameniscal, Baker's, or ganglion&#xD;
             cysts v. lipoma arborescens vi. Hoffa's Pad Syndrome vii. acute ligament tears viii.&#xD;
             diffuse edema ix. patellar mal-tracking or patellar dislocations&#xD;
&#xD;
          2. Outerbridge Scale Grade 0-I as diagnosed on MRI&#xD;
&#xD;
          3. Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage&#xD;
             is greater than 2.5 cm in any direction, as diagnosed on MRI&#xD;
&#xD;
          4. Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature.&#xD;
&#xD;
          5. Subjects who have had surgery of either knee within 6 months prior to the surgery&#xD;
             visit&#xD;
&#xD;
          6. Subjects who have had a major injury to either knee within 12 months prior to the&#xD;
             surgery visit&#xD;
&#xD;
          7. Subjects who have had an injection into the intraarticular space of either knee in the&#xD;
             prior 6 months, including corticosteroids, viscosupplementation, stromal vascular&#xD;
             fraction (SVF), bone marrow stem cells, or platelet rich plasma&#xD;
&#xD;
          8. Subjects who have a diagnosis of gout with a flare in the past 12 months.&#xD;
&#xD;
          9. Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12&#xD;
             months.&#xD;
&#xD;
         10. Subjects who have had a diagnosed infection in the knee joint in the past 12 months.&#xD;
&#xD;
         11. Subject who have received a diagnosis of the following at any time: rheumatoid&#xD;
             arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, fibromyalgia,&#xD;
             or neurogenic or vascular claudication&#xD;
&#xD;
         12. Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus&#xD;
             or valgus deformity&#xD;
&#xD;
         13. Subjects that are unwilling to stop taking prescription or over the counter pain&#xD;
             medication 7 days prior to any visit (except Day 2 Post Treatment Visit).&#xD;
&#xD;
         14. Subjects that are allergic to lidocaine, epinephrine or valium&#xD;
&#xD;
         15. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be&#xD;
             stopped as follows prior to injection; thrombolytics and anti-platelet medication&#xD;
             including but not limited to Coumadin (warfarin) for 3 days, Plavix (colpidogrel) for&#xD;
             3 days, ASA/NSAIDs/fish oil supplements for 7 days, Xarelto® (rivaroxaban) for 24&#xD;
             hours&#xD;
&#xD;
         16. Subjects with systemic immunosuppressant use within 6 weeks from screening&#xD;
&#xD;
         17. Subjects with HIV or viral hepatitis&#xD;
&#xD;
         18. Subjects who have ever received a diagnosis of:&#xD;
&#xD;
             chondrocalcinosis, Paget's disease or Villonodular synovitis&#xD;
&#xD;
         19. Subjects that use any form of tobacco, including e-cigarettes, more than once a week&#xD;
             over the most recent 1 year period&#xD;
&#xD;
         20. Women that are pregnant or planning to become pregnant during the study&#xD;
&#xD;
         21. Subjects on long term oral steroids defined as longer than a 2-week taper.&#xD;
&#xD;
         22. History of any chemotherapy or radiation therapy on either leg or adipose harvest site&#xD;
&#xD;
         23. Subjects currently on workers' compensation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Cimino, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>GID BIO</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandeep Samudre, PhD, MPH</last_name>
    <phone>303-952-4901</phone>
    <phone_ext>105</phone_ext>
    <email>s.samudre@gidbio.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Advanced Research LLC</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wafa Abdelaziz</last_name>
      <phone>954-302-3047</phone>
      <email>Wabdelaziz@advancedresearchfl.com</email>
    </contact>
    <contact_backup>
      <last_name>Vivek Sawhney</last_name>
      <phone>954-204-0052</phone>
      <email>vsawhney@advancedresearchfl.com</email>
    </contact_backup>
    <investigator>
      <last_name>Manish Gupta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advent Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Tulane University</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Callegari</last_name>
      <phone>504-988-0200</phone>
      <email>ctu@tulane.edu</email>
    </contact>
    <investigator>
      <last_name>Jaime R Garza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New Jersey Regenerative Institute</name>
      <address>
        <city>Cedar Knolls</city>
        <state>New Jersey</state>
        <zip>07927</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erica Hartzell</last_name>
      <phone>336-713-3824</phone>
      <email>ehartzel@wakehealth.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nina Cruz-Diaz</last_name>
      <phone>336.716.0824</phone>
      <email>nmcruzdi@wakehealth.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Neil Sparks, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adam Katz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian Waterman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxwell Langfitt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Miles, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heath Thornton, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Linter, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ohio State University Jameson Crane Sports Medicine Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleanor Shirley, MA, CCRC</last_name>
      <phone>412-383-7712</phone>
      <email>shirleye@upmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Eleanor Shirley, MA, CCRC</last_name>
      <email>shirleye@upmc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>J. Peter Rubin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Center for Cell Therapy and Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.</citation>
    <PMID>32109160</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</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>
  <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/NCT04440189
org study id: GIDOA-03
nct id: NCT04440189
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study is a pivotal study to evaluate the efficacy and safety of a single injection of
      autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of
      pain with concomitant improvement in function associated with osteoarthritis of the knee
      joint.
This is a prospective, randomized, placebo controlled, parallel groups, double blind,
      multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will
      be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose
      tissue (experimental).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Western Ontario and McMaster Universities Arthritis Index
time frame: 6 months
description: The WOMAC is a self-administered questionnaire consisting of 14 items divided into 3 subscales, pain, stiffness and function. The primary efficacy will be achieved if the SVF dose group is shown to have a clinically meaningful improvement in pain and function at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The overall WOMAC score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.
measure: Adverse Events
time frame: 12 months
description: Summary of device, treatment and procedure related adverse event rates and severity
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive an injection of Lactated Ringers in their index knee
arm group label: Stromal Vascular Fraction (SVF)
arm group type: Experimental
description: Subjects will receive an injection of Stromal Vascular Fraction in their index knee
intervention type: Device
intervention name: GID SVF-2 Device System
description: The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.
arm group label: Placebo
arm group label: Stromal Vascular Fraction (SVF)
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Cimino, PhD
role: Study Chair
affiliation: GID BIO
last name: Sandeep Samudre, PhD, MPH
phone: 303-952-4901
phone ext: 105
email: s.samudre@gidbio.com
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Enrolling by invitation
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
citation: Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
PMID: 32109160
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No