<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/NCT02216630</url>
  </required_header>
  <id_info>
    <org_study_id>KS-SVF-1002</org_study_id>
    <nct_id>NCT02216630</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>An Open-label, Non-Randomized, Multi-center Study to Assess the Safety and Effects of Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kimera Society Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kimera Society Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be an open-label, non-randomized multi-center study designed to assess the safety&#xD;
      and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of&#xD;
      cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect&#xD;
      the adipose tissue specimen for subsequent processing to isolate the stem cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the context of the proposed study, adipose derived stem cells (ASC) constitute an&#xD;
      autologous cell product that is delivered to the patient via intra-venous injection. In this&#xD;
      study, we propose to investigate the immunosuppressive potential of the non-manipulated&#xD;
      non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured&#xD;
      both by improvement of the forced evacuation volume in one second (FEV1) and distance covered&#xD;
      in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal&#xD;
      cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured&#xD;
      but are isolated from adipose tissue using a sterile tissue process in under two hours. The&#xD;
      process includes rinsing in a saline solution to remove red blood cells, draining, and&#xD;
      enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue.&#xD;
      Post-processing, the pellet obtained via centrifugation is filtered and delivered to the&#xD;
      patient who remains sedated within the same ambulatory center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>FEV1 Decline</measure>
    <time_frame>12 months</time_frame>
    <description>The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Objective</measure>
    <time_frame>12 Months</time_frame>
    <description>The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Adipose-Derived Stem Cell (ADSC) Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adipose Derived Stem Cell (ADSC) Therapy</intervention_name>
    <description>Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.</description>
    <arm_group_label>Adipose-Derived Stem Cell (ADSC) Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 85, inclusive&#xD;
&#xD;
          -  A prior diagnosis of moderate to severe COPD&#xD;
&#xD;
          -  GOLD IIa, III, IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Life expectancy &lt; 6 months due to concomitant illnesses.&#xD;
&#xD;
          -  Exposure to any investigational drug or procedure within 1 month prior to study entry&#xD;
             or enrolled in a concurrent study that may confound results of this study.&#xD;
&#xD;
          -  Any illness which, in the Investigators judgment, will interfere with the patient's&#xD;
             ability to comply with the protocol, compromise patient safety, or interfere with the&#xD;
             interpretation of study results&#xD;
&#xD;
          -  Subjects on chronic immunosuppressive or chemotherapeutic therapy&#xD;
&#xD;
          -  Known drug or alcohol dependence or any other factors which will interfere with the&#xD;
             study conduct or interpretation of the results or who in the opinion of the&#xD;
             investigator are not suitable to participate.&#xD;
&#xD;
          -  Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause&#xD;
             lung disease and liver disease).&#xD;
&#xD;
          -  Unwilling and/or not able to give written consent&#xD;
&#xD;
          -  Patient is positive for hepatitis (past history of Hepatitis A is allowed)&#xD;
&#xD;
          -  Any medical condition, which in the opinion of the clinical investigator, would&#xD;
             interfere with the treatment or outcome of the patient&#xD;
&#xD;
          -  Cerebral aneurysm clips&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Melvin Propis M.D.</name>
      <address>
        <city>Davie</city>
        <state>Florida</state>
        <zip>33330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Costa Rica</country>
    <country>Nicaragua</country>
  </removed_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02216630
org study id: KS-SVF-1002
nct id: NCT02216630
lead sponsor: 
has dmc: No
This will be an open-label, non-randomized multi-center study designed to assess the safety
      and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of
      cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect
      the adipose tissue specimen for subsequent processing to isolate the stem cells.
In the context of the proposed study, adipose derived stem cells (ASC) constitute an
      autologous cell product that is delivered to the patient via intra-venous injection. In this
      study, we propose to investigate the immunosuppressive potential of the non-manipulated
      non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured
      both by improvement of the forced evacuation volume in one second (FEV1) and distance covered
      in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal
      cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured
      but are isolated from adipose tissue using a sterile tissue process in under two hours. The
      process includes rinsing in a saline solution to remove red blood cells, draining, and
      enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue.
      Post-processing, the pellet obtained via centrifugation is filtered and delivered to the
      patient who remains sedated within the same ambulatory center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: FEV1 Decline
time frame: 12 months
description: The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.
measure: Number of Adverse Events
time frame: 12 months
measure: Secondary Efficacy Objective
time frame: 12 Months
description: The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.
arm group label: Adipose-Derived Stem Cell (ADSC) Therapy
arm group type: Experimental
description: This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy
intervention type: Drug
intervention name: Adipose Derived Stem Cell (ADSC) Therapy
description: Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.
arm group label: Adipose-Derived Stem Cell (ADSC) Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: Costa Rica
country: Nicaragua
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive