<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/NCT04486001</url>
  </required_header>
  <id_info>
    <org_study_id>PSC-CP-004</org_study_id>
    <nct_id>NCT04486001</nct_id>
  </id_info>
  <brief_title>Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19</brief_title>
  <acronym>CoronaStem1</acronym>
  <official_title>COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sorrento Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VetStem Biopharma, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fresno Community Hospital and Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sorrento Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed rapidly assess safety and preliminary efficacy in hospitalized&#xD;
      patients with COVID-19 respiratory distress to provide clinical guidance for possible wider&#xD;
      use in treating patients in this pandemic environment. This data will be used for FDA IND&#xD;
      filings and pursuit of a BLA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy&#xD;
      of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be&#xD;
      compared to contemporaneous non-enrolled patients at the same clinical site(s) as the&#xD;
      enrolled patients.&#xD;
&#xD;
      Study Objectives:&#xD;
&#xD;
      Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in&#xD;
      patients with COVID-19 disease and respiratory distress.&#xD;
&#xD;
      Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give&#xD;
      guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single group comparison with cohort of contemporaneous non-treated patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of all adverse events</measure>
    <time_frame>Through study completion, an average of three months</time_frame>
    <description>Frequency of all reported adverse events in study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of infusion related serious adverse events</measure>
    <time_frame>6 hours post infusion</time_frame>
    <description>Frequency of SAEs in the 6 hours post-infusion for each infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of serious adverse events</measure>
    <time_frame>Through study completion, an average of three months</time_frame>
    <description>Frequency of all serious adverse events in study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Study days 0-28</time_frame>
    <description>All-cause mortality through Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator Free Days</measure>
    <time_frame>Study days 0-28</time_frame>
    <description>Ventilator free days through Study day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Free Days</measure>
    <time_frame>Days 0 through 28</time_frame>
    <description>Total days not in ICU from Study day 0 through Study day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Hospital Days</measure>
    <time_frame>Days 0 through discharge, an average of 28 days</time_frame>
    <description>Total Days in Hospital from Day 0 through discharge for survivors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total ICU Days</measure>
    <time_frame>Days 0 through discharge, an average of 28 days</time_frame>
    <description>Total Days in ICU from Day 0 through discharge for survivors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Oxygenation</measure>
    <time_frame>Study days 0, 2, 4, 6</time_frame>
    <description>Improvement in oxygenation comparing Study day 0, to days 2, 4, 6</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is single arm study with only comparison to non-treated cohorts at site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PSC-04</intervention_name>
    <description>adipose stem cells derived from screened donor lipoaspirate and culture expanded.</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>allogeneic, adipose-derived stem cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to hospital as in-patient (ward or ICU)&#xD;
&#xD;
          -  Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 &lt;300)&#xD;
&#xD;
          -  Bilateral lung infiltrates (CT or frontal X-ray)&#xD;
&#xD;
          -  Supplemental oxygen started but NOT intubated or ventilated&#xD;
&#xD;
          -  COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test);&#xD;
&#xD;
          -  CDC confirmation not necessary&#xD;
&#xD;
          -  Time from Enrollment to treatment must be less than 24 hours&#xD;
&#xD;
          -  Age: 18-80 years&#xD;
&#xD;
          -  Gender: any&#xD;
&#xD;
          -  Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor&#xD;
             the patient is suitable for cellular therapy&#xD;
&#xD;
          -  Cognitive function: Able to understand and willing to sign informed consent form or&#xD;
             legally authorized representative or surrogate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intubation / ventilation&#xD;
&#xD;
          -  Current therapy is working, and patient is clinically improving&#xD;
&#xD;
          -  Disease Conditions: Heart failure severe (NY Heart Association Classification IV);&#xD;
             Clinical evidence of left heart failure or volume overload as a primary explanation&#xD;
             for the bilateral pulmonary infiltrates; Any disease or condition other than current&#xD;
             respiratory COVID-19 disease for which 6-month mortality is estimated to be greater&#xD;
             than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the&#xD;
             use of home oxygen use prior to this current illness; Currently receiving&#xD;
             extracorporeal life support (ECLS/ECMO)&#xD;
&#xD;
          -  Past Disease Conditions: Any history of malignancy within the last 2 years (except for&#xD;
             patients in remission or cured of the malignancy); Lung transplant patient or&#xD;
             lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History&#xD;
             of splenectomy&#xD;
&#xD;
          -  Other Experimental Conditions: Currently enrolled or treated in last 60 days in&#xD;
             another clinical study&#xD;
&#xD;
          -  Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung&#xD;
             protective ventilation strategy, if needed&#xD;
&#xD;
          -  Concurrent disease or circumstances that Investigator or Sponsor judges to be an&#xD;
             unacceptable risk to patient health or a confounding variable to assessment or problem&#xD;
             in completion of trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Royal, MD JD</last_name>
    <role>Study Director</role>
    <affiliation>Sorrento Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fresno Community Hospital</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Rogers CJ, Harman RJ, Bunnell BA, Schreiber MA, Xiang C, Wang FS, Santidrian AF, Minev BR. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med. 2020 May 18;18(1):203. doi: 10.1186/s12967-020-02380-2.</citation>
    <PMID>32423449</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adipose</keyword>
  <keyword>stem cell</keyword>
  <keyword>COVID19</keyword>
  <keyword>COVID-19</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04486001
org study id: PSC-CP-004
nct id: NCT04486001
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed rapidly assess safety and preliminary efficacy in hospitalized
      patients with COVID-19 respiratory distress to provide clinical guidance for possible wider
      use in treating patients in this pandemic environment. This data will be used for FDA IND
      filings and pursuit of a BLA.
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy
      of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be
      compared to contemporaneous non-enrolled patients at the same clinical site(s) as the
      enrolled patients.

      Study Objectives:

      Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in
      patients with COVID-19 disease and respiratory distress.

      Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give
      guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single group comparison with cohort of contemporaneous non-treated patients.
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of all adverse events
time frame: Through study completion, an average of three months
description: Frequency of all reported adverse events in study
measure: Frequency of infusion related serious adverse events
time frame: 6 hours post infusion
description: Frequency of SAEs in the 6 hours post-infusion for each infusion
measure: Frequency of serious adverse events
time frame: Through study completion, an average of three months
description: Frequency of all serious adverse events in study
measure: Mortality
time frame: Study days 0-28
description: All-cause mortality through Day 28
measure: Ventilator Free Days
time frame: Study days 0-28
description: Ventilator free days through Study day 28
measure: ICU Free Days
time frame: Days 0 through 28
description: Total days not in ICU from Study day 0 through Study day 28
measure: Total Hospital Days
time frame: Days 0 through discharge, an average of 28 days
description: Total Days in Hospital from Day 0 through discharge for survivors
measure: Total ICU Days
time frame: Days 0 through discharge, an average of 28 days
description: Total Days in ICU from Day 0 through discharge for survivors
measure: Improvement in Oxygenation
time frame: Study days 0, 2, 4, 6
description: Improvement in oxygenation comparing Study day 0, to days 2, 4, 6
arm group label: Treatment Group
arm group type: Experimental
description: This is single arm study with only comparison to non-treated cohorts at site.
intervention type: Biological
intervention name: PSC-04
description: adipose stem cells derived from screened donor lipoaspirate and culture expanded.
arm group label: Treatment Group
other name: allogeneic, adipose-derived stem cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mike Royal, MD JD
role: Study Director
affiliation: Sorrento Therapeutics, Inc.
facility: 
country: United States
citation: Rogers CJ, Harman RJ, Bunnell BA, Schreiber MA, Xiang C, Wang FS, Santidrian AF, Minev BR. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med. 2020 May 18;18(1):203. doi: 10.1186/s12967-020-02380-2.
PMID: 32423449
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No