<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/NCT03228121</url>
  </required_header>
  <id_info>
    <org_study_id>LI003</org_study_id>
    <nct_id>NCT03228121</nct_id>
  </id_info>
  <brief_title>Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD</brief_title>
  <official_title>Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lung Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lung Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized, controlled crossover designed study is to compare the outcomes of&#xD;
      receiving autologous, adult stem cells versus placebo among participants with chronic&#xD;
      obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a&#xD;
      diagnosis of COPD. The study, along with others at the Lung Institute, have received full&#xD;
      review and approval of an Institutional Review Board.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the Lung Institute is to collect, minimally process, and administer a person's&#xD;
      own stem cells and/or platelet rich plasma and deliver the product back to the patient&#xD;
      same-day through an intravenous catheter. This study is limited to patients diagnosed with&#xD;
      chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort&#xD;
      trial using cross-over methodology. The aim of this study is to determine if stem cell&#xD;
      therapy is better than placebo among a group of patients with COPD.&#xD;
&#xD;
      50 participants will be recruited for each arm of the study.&#xD;
&#xD;
      Cohort A will receive three days of cell therapy using the venous procedure (three&#xD;
      consecutive days of blood harvest, cell separation and cell application). Cohort A will&#xD;
      return in three months and receive three consecutive days of placebo.&#xD;
&#xD;
      Cohort B will receive three consecutive days of placebo. Cohort B will return in three months&#xD;
      and receive three consecutive days of cell therapy using the venous procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Enrollment did not meet expectations&#xD;
  </why_stopped>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">September 11, 2018</completion_date>
  <primary_completion_date type="Actual">September 11, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>0 participants will be recruited for each arm of the study.&#xD;
Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.&#xD;
Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Only the on-site PI and research nurse administering the treatment or placebo will know which group the participant belongs to. Patients are blinded. All follow-up contact and measurement of outcomes will be done by off-site research nurses who are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life Score</measure>
    <time_frame>3 months, 6 months following each treatment</time_frame>
    <description>Change in QOL score from baseline to 3 months and 6 months following each treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1</measure>
    <time_frame>6 months following each treatment</time_frame>
    <description>Change in FEV1 from baseline to 6 months post-treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COPD</condition>
  <condition>Emphysema or COPD</condition>
  <condition>Chronic Bronchitis</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort A (Treatment Then Placebo group) will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort B (Placebo Then Treatment group) will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment Then Placebo</intervention_name>
    <description>Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.</description>
    <arm_group_label>Cohort A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo Then Treatment</intervention_name>
    <description>Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are included in treatment by self-referral and after consultation with a&#xD;
             designated patient coordinator who determines initial eligibility, and then by the&#xD;
             clinic nurse practitioner or physician of Lung Institute who determines final&#xD;
             eligibility for inclusion. Patients must be diagnosed with chronic obstructive&#xD;
             pulmonary disease (COPD) and be able to travel to the Dallas clinic location.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unable to provide informed consent, pregnant patients, prisoners,&#xD;
             non-English speakers, patients with a history of cancer within the past 5 years,&#xD;
             patients with active tuberculosis or pneumonia. Patients without a documented COPD&#xD;
             diagnosis are excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lung Institute Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>September 11, 2018</last_update_submitted>
  <last_update_submitted_qc>September 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lung Institute</investigator_affiliation>
    <investigator_full_name>Melissa Rubio, PhD, APRN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Emphysema</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/NCT03228121
org study id: LI003
nct id: NCT03228121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized, controlled crossover designed study is to compare the outcomes of
      receiving autologous, adult stem cells versus placebo among participants with chronic
      obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a
      diagnosis of COPD. The study, along with others at the Lung Institute, have received full
      review and approval of an Institutional Review Board.
The purpose of the Lung Institute is to collect, minimally process, and administer a person's
      own stem cells and/or platelet rich plasma and deliver the product back to the patient
      same-day through an intravenous catheter. This study is limited to patients diagnosed with
      chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort
      trial using cross-over methodology. The aim of this study is to determine if stem cell
      therapy is better than placebo among a group of patients with COPD.

      50 participants will be recruited for each arm of the study.

      Cohort A will receive three days of cell therapy using the venous procedure (three
      consecutive days of blood harvest, cell separation and cell application). Cohort A will
      return in three months and receive three consecutive days of placebo.

      Cohort B will receive three consecutive days of placebo. Cohort B will return in three months
      and receive three consecutive days of cell therapy using the venous procedure.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 0 participants will be recruited for each arm of the study.
Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.
Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Only the on-site PI and research nurse administering the treatment or placebo will know which group the participant belongs to. Patients are blinded. All follow-up contact and measurement of outcomes will be done by off-site research nurses who are blinded.
measure: Change in Quality of Life Score
time frame: 3 months, 6 months following each treatment
description: Change in QOL score from baseline to 3 months and 6 months following each treatment
measure: Change in FEV1
time frame: 6 months following each treatment
description: Change in FEV1 from baseline to 6 months post-treatment
arm group label: Cohort A
arm group type: Experimental
description: Cohort A (Treatment Then Placebo group) will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.
arm group label: Cohort B
arm group type: Experimental
description: Cohort B (Placebo Then Treatment group) will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.
intervention type: Procedure
intervention name: Treatment Then Placebo
description: Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.
arm group label: Cohort A
intervention type: Procedure
intervention name: Placebo Then Treatment
description: Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.
arm group label: Cohort B
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lung Institute
investigator full name: Melissa Rubio, PhD, APRN
investigator title: Principal Investigator
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Emphysema
sharing ipd: No