<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/NCT03040674</url>
  </required_header>
  <id_info>
    <org_study_id>LI002 Cohort A</org_study_id>
    <nct_id>NCT03040674</nct_id>
  </id_info>
  <brief_title>An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease</brief_title>
  <official_title>An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease</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 purpose of the Lung Institute is to collect and isolate a patient's own cells and&#xD;
      platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung&#xD;
      Institute's treatment is limited to self- funded patients with chronic lung disease - chronic&#xD;
      obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells&#xD;
      and platelet rich plasma are collected through venous harvesting.&#xD;
&#xD;
      The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse&#xD;
      events, a perceived improvement in the patient's lung condition (to be determined by their&#xD;
      ability to be more physically active; walking greater distances with or without oxygen and&#xD;
      improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability&#xD;
      to reduce their use of oxygen and possibly to stop it., the ability to function well without&#xD;
      the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction&#xD;
      in emergency room visits and exacerbations related to their disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through the collection of outcome data, Lung Institute aims to explore and describe the&#xD;
      safety and efficacy of autologous cellular therapy for chronic lung disease with&#xD;
      dissemination to the public and to the medical community for the advancement of regenerative&#xD;
      medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect&#xD;
      of autologous cell therapy treatment on pulmonary function, and to describe the anecdotal&#xD;
      quality of life changes of patients following treatment using both quantitative and&#xD;
      qualitative measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life (QOL) From Baseline</measure>
    <time_frame>Measurements pre-treatment then at 3 and 6 months post-treatment</time_frame>
    <description>• Change from baseline in overall perceived quality of life over the course of a 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60.&#xD;
The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in MMRC Scale From Baseline</measure>
    <time_frame>Measurements pre-treatment then at 3 months post-treatment</time_frame>
    <description>• Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in FEV1 From Baseline</measure>
    <time_frame>Measurements pre-treatment and at 3 months post-treatment</time_frame>
    <description>•Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.&#xD;
The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">489</enrollment>
  <condition>COPD</condition>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Cell therapy treated</arm_group_label>
    <description>All patients/participants enrolled will undergo cell therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cell therapy</intervention_name>
    <description>Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day</description>
    <arm_group_label>Cell therapy treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all patients treated with cell therapy at Lung Institute&#xD;
        Dallas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <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;
             nurse practitioner or physician of the Lung Institute who determines final eligibility&#xD;
             for treatment. All eligible and thereby traded patients are eligible for the study&#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. In addition, patients on prescribed&#xD;
             blood thinners, with a history of breast or prostate cancer of any time frame or with&#xD;
             a history of osteoporosis are excluded from the bone marrow harvest option.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Rubio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <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>
  <link>
    <url>http://lunginstitute.com</url>
    <description>Clinic webpage</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>March 1, 2021</results_first_submitted>
  <results_first_submitted_qc>April 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2021</results_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</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>
  <keyword>Shortness of breath</keyword>
  <keyword>Breathlessness</keyword>
  <keyword>Cellular therapy</keyword>
  <keyword>Platelet rich plasma</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Pulmonary function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03040674/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03040674/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from the clinic site in Dallas, Texas. Participants were all diagnosed with either COPD or interstitial lung disease by their personal pulmonologist. Records review by provider including diagnosis, past medical history, medications, labs from within 3 months, lung function test results and the participants' ability to travel to and from the treatment site were assessed prior to approval. This study is IRB approved and each participant signed Informed Consent.</recruitment_details>
      <pre_assignment_details>All participants who started in the study were contacted at least twice at 3- and 6- months post-treatment by phone for quality of life follow-up. Participants were lost to follow-up at each time interval if they did not answer or return the call.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cell Therapy Treated</title>
          <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive autologous cellular therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood. After harvest, cells are processed using minimal manipulation for platelet-rich plasma/ platelet concentrate (from peripheral blood) and/or mesenchymal stem cells (from bone marrow) and returned to the patient via peripheral circulation on the same day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="489"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Completing 3 Month Survey</title>
              <participants_list>
                <participants group_id="P1" count="351"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Completing 6 Month Survey</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="248"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="225"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>489 participants were assessed at baseline</population>
      <group_list>
        <group group_id="B1">
          <title>Cell Therapy Treated</title>
          <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="489"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.59" lower_limit="25" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="461"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic Lung Disease Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Chronic Obstructive Pulmonary Disease (COPD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interstitial Lung Disease (ILD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Quality of Life (QOL) From Baseline</title>
        <description>• Change from baseline in overall perceived quality of life over the course of a 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60.&#xD;
The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.</description>
        <time_frame>Measurements pre-treatment then at 3 and 6 months post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cell Therapy Treated</title>
            <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive autologous cellular therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood. After harvest, cells are processed using minimal manipulation for platelet-rich plasma/ platelet concentrate (from peripheral blood) and/or mesenchymal stem cells (from bone marrow) and returned to the patient via peripheral circulation on the same day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life (QOL) From Baseline</title>
          <description>• Change from baseline in overall perceived quality of life over the course of a 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60.&#xD;
The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline CCQ Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.35" spread="10.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CCQ Score 3-Months Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.96" spread="10.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CCQ Score 6 Months Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.87" spread="10.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in MMRC Scale From Baseline</title>
        <description>• Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.</description>
        <time_frame>Measurements pre-treatment then at 3 months post-treatment</time_frame>
        <population>191 participants answered the MMRC questionnaire at baseline and again at 3-months post-treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Cell Therapy Treated</title>
            <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in MMRC Scale From Baseline</title>
          <description>• Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.</description>
          <population>191 participants answered the MMRC questionnaire at baseline and again at 3-months post-treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MMRC Score 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Month Follow-Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC Score 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Month Follow-Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC Score 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Month Follow-Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC Score 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Month Follow-Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC Score 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Month Follow-Up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in FEV1 From Baseline</title>
        <description>•Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.&#xD;
The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.</description>
        <time_frame>Measurements pre-treatment and at 3 months post-treatment</time_frame>
        <population>175 participants with COPD had pulmonary function measurements taken at baseline and at 3-months post-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cell Therapy Treated</title>
            <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in FEV1 From Baseline</title>
          <description>•Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.&#xD;
The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.</description>
          <population>175 participants with COPD had pulmonary function measurements taken at baseline and at 3-months post-treatment.</population>
          <units>percentage of predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FEV1% Predicted at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV1% Predicted 3-Months Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected for up to 1 year for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cell Therapy Treated</title>
          <description>All patients/participants enrolled will undergo cell therapy&#xD;
Cell therapy: Each participant will receive cell therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="489"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="489"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="489"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was an observational study only with no control (placebo) group and was designed to examine the outcomes of participants following cellular therapy. This study makes no comparison to placebo or any other treatment. Participants incurred the cost of treatment and travel to the treatment center. This study and treatment protocol was approved by Advarra IRB for Human Subjects Protection.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Melissa Rubio, PhD, APRN</name_or_title>
      <organization>Lung Health Institute</organization>
      <phone>2145042117</phone>
      <email>pidallas@thelunghealthinstitute.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03040674
org study id: LI002 Cohort A
nct id: NCT03040674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the Lung Institute is to collect and isolate a patient's own cells and
      platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung
      Institute's treatment is limited to self- funded patients with chronic lung disease - chronic
      obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells
      and platelet rich plasma are collected through venous harvesting.

      The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse
      events, a perceived improvement in the patient's lung condition (to be determined by their
      ability to be more physically active; walking greater distances with or without oxygen and
      improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability
      to reduce their use of oxygen and possibly to stop it., the ability to function well without
      the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction
      in emergency room visits and exacerbations related to their disease.
Through the collection of outcome data, Lung Institute aims to explore and describe the
      safety and efficacy of autologous cellular therapy for chronic lung disease with
      dissemination to the public and to the medical community for the advancement of regenerative
      medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect
      of autologous cell therapy treatment on pulmonary function, and to describe the anecdotal
      quality of life changes of patients following treatment using both quantitative and
      qualitative measures.
observational model: Cohort
time perspective: Prospective
measure: Change in Quality of Life (QOL) From Baseline
time frame: Measurements pre-treatment then at 3 and 6 months post-treatment
description: • Change from baseline in overall perceived quality of life over the course of a 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60.
The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.
measure: Change in MMRC Scale From Baseline
time frame: Measurements pre-treatment then at 3 months post-treatment
description: • Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.
measure: Change in FEV1 From Baseline
time frame: Measurements pre-treatment and at 3 months post-treatment
description: •Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.
The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.
arm group label: Cell therapy treated
description: All patients/participants enrolled will undergo cell therapy
intervention type: Procedure
intervention name: Cell therapy
description: Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day
arm group label: Cell therapy treated
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa Rubio, PhD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: United States
url: http://lunginstitute.com
description: Clinic webpage
responsible party type: Principal Investigator
investigator affiliation: Lung Institute
investigator full name: Melissa Rubio, PhD, APRN
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was an observational study only with no control (placebo) group and was designed to examine the outcomes of participants following cellular therapy. This study makes no comparison to placebo or any other treatment. Participants incurred the cost of treatment and travel to the treatment center. This study and treatment protocol was approved by Advarra IRB for Human Subjects Protection.
point of contact: 