<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/NCT04428801</url>
  </required_header>
  <id_info>
    <org_study_id>CTX0020-003</org_study_id>
    <nct_id>NCT04428801</nct_id>
  </id_info>
  <brief_title>Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19</brief_title>
  <official_title>Clinical Study for the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celltex Therapeutics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celltex Therapeutics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with&#xD;
      200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative,&#xD;
      no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot&#xD;
      study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous&#xD;
      AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with&#xD;
      Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells)&#xD;
      intravenous infusion every three days. The 100 subjects in the control group who have&#xD;
      previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but&#xD;
      placebo treatments. All subjects are monitored for safety (adverse events/severe adverse&#xD;
      events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies&#xD;
      tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity&#xD;
      evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6&#xD;
      months after the enrollment for the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2023</start_date>
  <completion_date type="Anticipated">September 2026</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The Phase 2 study is a randomized, double-blind, placebo-control study conducted in multiple clinic facilities.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients and evaluators</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication</measure>
    <time_frame>6 months</time_frame>
    <description>adverse events and severe adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group</measure>
    <time_frame>6 months</time_frame>
    <description>adverse events and severe adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 incidence rates in both the study and control groups</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of lymphocyte count in white blood cell counts from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of PaO2 arterial blood gases from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the proportion of subjects who develop severe COVID-19 pneumonia cases for both study and control groups</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 mortality rates for both study and control groups</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of C-reactive protein (CRP) (mg/L) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of D-dimer (mg/L) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Procalcitonin (ug)/L from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of pro-type B natriuretic peptide (pro-BNP) (pg/mL) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Bilirubin (mg/dL) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Creatinine (mg/dL) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood test values for cytokine panels (IL-1β, IL-6, IL-8, IL-10, TNFα) from the baseline</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects from SARS-CoV-2 RT-PCR positive to negativity in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method. as compared to control group</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantifying viral RNA in stool for baseline and final follow-up.</measure>
    <time_frame>6 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Phase 2 AdMSC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject receives three doses of 200 million autologous adipose derived mesenchymal stem cells via intravenously infusion every three days&#xD;
Other Names: Celltex-AdMSCs Celltex-AdMSCs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group- receive three doses of placebo via intravenously infusion every three days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous adipose-derived stem cells</intervention_name>
    <description>Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue</description>
    <arm_group_label>Phase 2 AdMSC group</arm_group_label>
    <arm_group_label>Phase 2 Placebo group</arm_group_label>
    <other_name>Celltex-AdMSCs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years.&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Subjects should have banked AdMSCs in Celltex (already passed communicable disease&#xD;
             screen tests for HIV, syphilis, Hepatitis B and C during banking stage)&#xD;
&#xD;
          -  Must understand and voluntarily sign an Informed Consent for study participation&#xD;
             obtained prior to undergoing any study-specific procedures&#xD;
&#xD;
          -  Highly susceptible to SARS-Cov-2 infections, such as obesity (BMI ≥ 40), early to&#xD;
             middle stage of hypertension (systolic pressure ranging above 140 Hg or a diastolic&#xD;
             pressure ranging from 90 mm Hg), diabetic mellitus hemoglobin A1c &gt;8%), chronic heart&#xD;
             disease (one or more conditions including previously diagnosed as coronary artery&#xD;
             disease, chronic heart arrhythmia, cardiomyopathy…) chronic pulmonary disease (COPD,&#xD;
             fibrosis), chronic liver disease (Hepatic impairment, defined as any of ALT, AST, LDH&#xD;
             or bilirubin &gt; 2 x the upper limit of normal (ULN) range according to local laboratory&#xD;
             standards) and kidney diseases (serum creatinine &gt; 133 mmol/L (1.5 mg/dL). No terminal&#xD;
             stages of the above medical conditions.&#xD;
&#xD;
          -  No previous COVID-19 history&#xD;
&#xD;
          -  SARS-CoV-2 RT-PCR or equivalent tests negative in respiratory tract specimen&#xD;
&#xD;
          -  Blood test for SARS-Cov-2 IgM and IgG negative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical study (with use of another Investigational Medical&#xD;
             Product) within 3 months prior to study treatment start&#xD;
&#xD;
          -  Unwillingness or inability to comply with study procedures&#xD;
&#xD;
          -  Blood test for SARS-Cov-2 antibodies IgM and IgG positive&#xD;
&#xD;
          -  Patients with serious basic diseases that affect survival, including blood diseases,&#xD;
             cachexia, active bleeding, severe malnutrition, etc.&#xD;
&#xD;
          -  Clinically active malignant disease&#xD;
&#xD;
          -  Previous thrombotic disorder&#xD;
&#xD;
          -  History of known pulmonary embolism or known secondary anti-phospholipid syndrome&#xD;
&#xD;
          -  Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g.&#xD;
             BSA and sulfur-containing products (e.g., DMSO)&#xD;
&#xD;
          -  Major trauma or surgery within 14 days of study treatment start&#xD;
&#xD;
          -  Mental condition rendering the subject (or the subject's legally acceptable&#xD;
             representative[s]) unable to understand the nature, scope and possible consequences of&#xD;
             the study&#xD;
&#xD;
          -  Alcohol, drug, or medication abuse within one year prior to study treatment start&#xD;
&#xD;
          -  Any condition in the Investigator's opinion that is likely to interfere with&#xD;
             evaluation of the AdMSC therapy or satisfactory conduct of the study&#xD;
&#xD;
          -  Irreversible severe end-organ failures, such as heart failure/attack, stroke, liver&#xD;
             and renal failure due to other disease conditions&#xD;
&#xD;
          -  Patients or family history with hypercoagulable states, such as protein C/protein S&#xD;
             deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.&#xD;
&#xD;
          -  History of long-term use of immunosuppressive agents&#xD;
&#xD;
          -  Organ transplant in the past 6 months&#xD;
&#xD;
          -  Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth&#xD;
             control during participation in the study duration, unless surgically sterilized or&#xD;
             postmenopausal during the study&#xD;
&#xD;
          -  Patients with severe pulmonary obstructive pneumonia, severe pulmonary interstitial&#xD;
             fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia&#xD;
             or bacterial pneumonia. This includes patients with pulmonary imaging that reveals&#xD;
             interstitial lung damage before contracting COVID-19.&#xD;
&#xD;
          -  QT interval shows greater than 450 ms in males and 470 ms in females in the medical&#xD;
             histories or during screen EKG test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek W Guillory, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Root Causes Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jane Young</last_name>
    <phone>7135901000</phone>
    <email>jyoung@celltexbank.com</email>
  </overall_contact>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>April 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19 [NCT ID not yet assigned]</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04428801
org study id: CTX0020-003
nct id: NCT04428801
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with
      200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative,
      no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot
      study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous
      AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with
      Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells)
      intravenous infusion every three days. The 100 subjects in the control group who have
      previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but
      placebo treatments. All subjects are monitored for safety (adverse events/severe adverse
      events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies
      tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity
      evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6
      months after the enrollment for the control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The Phase 2 study is a randomized, double-blind, placebo-control study conducted in multiple clinic facilities.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients and evaluators
measure: Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication
time frame: 6 months
description: adverse events and severe adverse events
measure: The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group
time frame: 6 months
description: adverse events and severe adverse events
measure: COVID-19 incidence rates in both the study and control groups
time frame: 6 months
description: efficacy
measure: The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.
time frame: 6 months
description: efficacy
measure: The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.
time frame: 6 months
description: efficacy
measure: Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.
time frame: 6 months
description: efficacy
measure: Change of lymphocyte count in white blood cell counts from the baseline
time frame: 6 months
description: efficacy
measure: Change of PaO2 arterial blood gases from the baseline
time frame: 6 months
description: efficacy
measure: Compare the proportion of subjects who develop severe COVID-19 pneumonia cases for both study and control groups
time frame: 6 months
description: efficacy
measure: COVID-19 mortality rates for both study and control groups
time frame: 6 months
description: efficacy
measure: Change of C-reactive protein (CRP) (mg/L) from the baseline
time frame: 6 months
description: efficacy
measure: Change of D-dimer (mg/L) from the baseline
time frame: 6 months
description: efficacy
measure: Change of Procalcitonin (ug)/L from the baseline
time frame: 6 months
description: efficacy
measure: Change of pro-type B natriuretic peptide (pro-BNP) (pg/mL) from the baseline
time frame: 6 months
description: efficacy
measure: Change of Bilirubin (mg/dL) from the baseline
time frame: 6 months
description: efficacy
measure: Change of Creatinine (mg/dL) from the baseline
time frame: 6 months
description: efficacy
measure: Change in blood test values for cytokine panels (IL-1β, IL-6, IL-8, IL-10, TNFα) from the baseline
time frame: 6 months
description: efficacy
measure: The proportion of subjects from SARS-CoV-2 RT-PCR positive to negativity in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method. as compared to control group
time frame: 6 months
description: efficacy
measure: Quantifying viral RNA in stool for baseline and final follow-up.
time frame: 6 months
description: efficacy
arm group label: Phase 2 AdMSC group
arm group type: Experimental
description: Each subject receives three doses of 200 million autologous adipose derived mesenchymal stem cells via intravenously infusion every three days
Other Names: Celltex-AdMSCs Celltex-AdMSCs
arm group label: Phase 2 Placebo group
arm group type: Placebo Comparator
description: The control group- receive three doses of placebo via intravenously infusion every three days.
intervention type: Biological
intervention name: autologous adipose-derived stem cells
description: Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
arm group label: Phase 2 AdMSC group
arm group label: Phase 2 Placebo group
other name: Celltex-AdMSCs
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Derek W Guillory, MD.
role: Principal Investigator
affiliation: Root Causes Medicine
last name: Jane Young
phone: 7135901000
email: jyoung@celltexbank.com
responsible party type: Sponsor
mesh term: COVID-19