<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/NCT02234778</url>
  </required_header>
  <id_info>
    <org_study_id>TGI-002-01-2013</org_study_id>
    <nct_id>NCT02234778</nct_id>
  </id_info>
  <brief_title>Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia</brief_title>
  <acronym>CLI-DI</acronym>
  <official_title>Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System™ for Autologous Adipose-Derived Stromal Vascular Fraction Cells to Treat Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tissue Genesis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Army Medical Research and Development Command</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Tissue Genesis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis®&#xD;
      Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device&#xD;
      removes certain cells from the adipose (fat) tissue which will be used to treat patients with&#xD;
      blockages in the arteries of their lower legs that may require a future amputation, which is&#xD;
      caused by severe peripheral artery disease (PAD). The purpose of this study is to determine&#xD;
      if treatment with cells that have been removed from the Icellator System™ device will reduce&#xD;
      the number of major amputations and deaths in a six month time period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>Amputation-Free Survival</measure>
    <time_frame>26 weeks</time_frame>
    <description>To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Study Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TGI SVF material via intramuscular injection</intervention_name>
    <description>Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.</description>
    <arm_group_label>Study Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critical limb ischemia (CLI), defined as ischemic pain at rest (Rutherford Category 4)&#xD;
             or minor tissue loss of the limb (Rutherford Category 5), and with either toe artery&#xD;
             occlusive pressure &lt; 50 mmHg or TBI ≤ 0.5 or ankle artery occlusion pressure ≤ 60 mm&#xD;
             Hg or ABI ≤ 0.5&#xD;
&#xD;
          -  No reasonable open or endovascular surgical options as determined by treating vascular&#xD;
             specialist&#xD;
&#xD;
          -  Competent to give consent&#xD;
&#xD;
          -  Age 21 years or greater&#xD;
&#xD;
          -  Females of child bearing potential agree to use acceptable methods of contraception&#xD;
             for the duration of the trial. Sexually active males agree to use an accepted and&#xD;
             effective method of contraception for the duration of the trial.&#xD;
&#xD;
          -  All diabetic subjects will undergo baseline and 12-month follow-up retinal&#xD;
             examinations conducted by a specialist&#xD;
&#xD;
          -  No current malignancy or history of previous malignancy within the last five years,&#xD;
             with the exception of adequately treated non-melanoma cutaneous carcinoma (basal cell&#xD;
             or squamous cell carcinoma of the skin).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major tissue loss of the index limb (Rutherford Category 6)&#xD;
&#xD;
          -  Limb revascularization surgery within 45 days of enrollment in this study&#xD;
&#xD;
          -  Subjects with less than 15% body fat as measured by calipers or electrical impedance&#xD;
&#xD;
          -  Subjects with less than a 2 cm x 2 cm roll of subcutaneous abdominal fat, when pinched&#xD;
             between the examiner's fingers, while the subject is in a supine position&#xD;
&#xD;
          -  Poorly controlled diabetes mellitus evidenced by HbA1C &gt; 10%. Diabetic subjects must&#xD;
             have evidence of a glycosylated hemoglobin test (HbA1C) performed within the last 30&#xD;
             days.&#xD;
&#xD;
          -  Uncompensated congestive heart failure (New York Heart Association Class IV) and/or&#xD;
             other conditions that preclude general anesthesia.&#xD;
&#xD;
          -  Myocardial infarction or stroke within the last 90 days.&#xD;
&#xD;
          -  Elevated liver function tests (AST or ALT more than twice the upper limit of normal).&#xD;
&#xD;
          -  Hematologic abnormalities.&#xD;
&#xD;
          -  Disease of the central nervous system and/or other conditions that impair cognitive&#xD;
             function.&#xD;
&#xD;
          -  History of two or more episodes of pulmonary embolus with a documented deep venous&#xD;
             thrombosis (DVT) (Duplex US or venography) in the index extremity or history of DVT in&#xD;
             the index extremity without evidence of clot resolution (Duplex US or venography)&#xD;
&#xD;
          -  Infection of the index leg&#xD;
&#xD;
          -  Pregnant or lactating females. Prior to enrollment, women of child-bearing potential&#xD;
             must have a negative urine pregnancy test.&#xD;
&#xD;
          -  Lower extremity venous disease or lymphedema with pitting edema in the index leg&#xD;
&#xD;
          -  Osteomyelitis in the index leg&#xD;
&#xD;
          -  Existing HIV diagnosis&#xD;
&#xD;
          -  Known terminal disease process with a life expectancy of less than one year&#xD;
&#xD;
          -  Subjects, in the investigator's opinion, requiring amputation within 30 days&#xD;
&#xD;
          -  Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac&#xD;
             artery and/or common femoral artery of the index leg&#xD;
&#xD;
          -  Presence of any clinical condition that in the opinion of the PI or the sponsor makes&#xD;
             the patient not suitable to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>critical limb ischemia</keyword>
  <keyword>autologous stromal vascular fraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT02234778
org study id: TGI-002-01-2013
nct id: NCT02234778
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis®
      Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device
      removes certain cells from the adipose (fat) tissue which will be used to treat patients with
      blockages in the arteries of their lower legs that may require a future amputation, which is
      caused by severe peripheral artery disease (PAD). The purpose of this study is to determine
      if treatment with cells that have been removed from the Icellator System™ device will reduce
      the number of major amputations and deaths in a six month time period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amputation-Free Survival
time frame: 26 weeks
description: To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.
arm group label: Study Treatment
arm group type: Experimental
description: Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation.
intervention type: Device
intervention name: TGI SVF material via intramuscular injection
description: Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.
arm group label: Study Treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia