<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/NCT04445220</url>
  </required_header>
  <id_info>
    <org_study_id>SBI-101-02</org_study_id>
    <nct_id>NCT04445220</nct_id>
  </id_info>
  <brief_title>A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy</brief_title>
  <official_title>A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sentien Biotechnologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sentien Biotechnologies, 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>
      The purpose of this study is to assess the safety and tolerability of the investigational&#xD;
      product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).&#xD;
      SBI-101 is a biologic/device combination product designed to regulate inflammation and&#xD;
      promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101&#xD;
      will be integrated into the renal replacement circuit and patients will be treated for up to&#xD;
      24 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 19, 2020</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability as measured by incidence of IP-related serious adverse events</measure>
    <time_frame>Outcomes and Serious Adverse Events through Day 180</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>COVID-19</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Low dose cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SBI-101 device containing 250 million MSCs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SBI-101 device containing 750 million MSCs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SBI-101</intervention_name>
    <description>SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.</description>
    <arm_group_label>High dose cohort</arm_group_label>
    <arm_group_label>Low dose cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood&#xD;
             cultures for systemic infection, active urinary sediment to suggest UTI, or any&#xD;
             imaging supportive of a clinical diagnosis of infection, for example, pulmonary&#xD;
             infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal&#xD;
             collection, etc.&#xD;
&#xD;
          -  AKI as determined by the Investigator based on his/her clinical judgment&#xD;
&#xD;
          -  Receiving or planned to receive RRT in &lt; 24 hours&#xD;
&#xD;
          -  Able to tolerate indwelling intravascular access&#xD;
&#xD;
          -  Has tolerated CRRT for at least 6 hours prior to IP treatment&#xD;
&#xD;
          -  Have maintained hemodynamic stability for at least 6 hours prior to IP treatment with&#xD;
             only minor changes in pressure support medication required (if used)&#xD;
&#xD;
          -  Vascular access (catheter placement) is patent and capable of supporting CRRT for the&#xD;
             duration of IP treatment&#xD;
&#xD;
          -  Likely to require RRT for at least an additional 48 hours&#xD;
&#xD;
          -  Potassium level &gt;3.6 and &lt;5.5 mEq/L or &gt;3.6 and &lt; 5.5 mmol/L prior to IP treatment&#xD;
&#xD;
          -  SaO2 &gt; 92% prior to IP initiation&#xD;
&#xD;
          -  Blood pH &gt; 7.2 prior to IP initiation&#xD;
&#xD;
          -  Medically cleared to receive anticoagulation per institutional standard of care / PI&#xD;
             prescribed protocol and meeting protocol defined anticoagulation targets prior to&#xD;
             receipt of IP&#xD;
&#xD;
          -  Ability to give informed consent or have a legally authorized representative do so&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subjects who are pregnant, planning to become pregnant, or lactating&#xD;
&#xD;
          -  MAP &lt;70 mmHg immediately prior to IP initiation&#xD;
&#xD;
          -  Systolic blood pressure &lt; 90 mmHg immediately prior to IP initiation&#xD;
&#xD;
          -  Mechanical ventilator support requiring FiO2 &gt; 80% prior to IP initiation&#xD;
&#xD;
          -  Receiving extracorporeal membrane oxygenation (ECMO)&#xD;
&#xD;
          -  Liver disease with Child Pugh score of &gt; 7 prior to IP initiation&#xD;
&#xD;
          -  High sensitivity cardiac Troponin level (hs-cTn) &gt; 100.0 ng/L prior to IP initiation&#xD;
             or other equivalent Troponin test result prior to IP initiation&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
&#xD;
          -  AKI due to post-renal outflow obstruction&#xD;
&#xD;
          -  Acute or chronic vasculitis of any etiology&#xD;
&#xD;
          -  Chronic systemic infection&#xD;
&#xD;
          -  Subjects with a past medical history of an inherited or acquired hypercoagulable&#xD;
             condition independent of COVID-19&#xD;
&#xD;
          -  Patients with a past medical history of an allergic response to MSC therapy&#xD;
&#xD;
          -  Participation in another interventional trial with the exception of studies of&#xD;
             antivirals, corticosteroids, hydroxychloroquine, azithromycin, or angiotensin&#xD;
             converting enzyme inhibitors/angiotensin receptor blockers (or related compounds)&#xD;
&#xD;
          -  Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with&#xD;
             the exception of non-melanoma skin cancer&#xD;
&#xD;
          -  Subjects, who in the opinion of the Investigator, are likely to require escalating&#xD;
             doses of vasopressors to attain and/or maintain hemodynamic stability, or subjects who&#xD;
             have reached the institutionally defined maximum level of vasopressor support within&#xD;
             12 hours of intended IP integration&#xD;
&#xD;
          -  Imminent death in &lt;24 hours&#xD;
&#xD;
          -  Organ failure affecting more than 2 non-renal organs&#xD;
&#xD;
          -  Platelet count &lt;50,000/μL or other serious hematological abnormalities that would&#xD;
             place subject in imminent danger of death&#xD;
&#xD;
          -  Lactate levels &gt;8 mmol/L suggestive of severe end-organ hypoperfusion prior to the&#xD;
             time of IP integration&#xD;
&#xD;
          -  Any prior medical condition or recent surgical procedure, planned significant medical&#xD;
             interventions or procedures that, in the judgment of the Investigator, would prevent&#xD;
             the subject from safely participating in and/or completing all study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of New Mexico School of Medicine</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CRRT</keyword>
  <keyword>AKI</keyword>
  <keyword>Continuous renal replacement therapy</keyword>
  <keyword>MSC</keyword>
  <keyword>Mesenchymal stromal cells</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <keyword>Stem cells</keyword>
  <keyword>Cell therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04445220
org study id: SBI-101-02
nct id: NCT04445220
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and tolerability of the investigational
      product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).
      SBI-101 is a biologic/device combination product designed to regulate inflammation and
      promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101
      will be integrated into the renal replacement circuit and patients will be treated for up to
      24 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability as measured by incidence of IP-related serious adverse events
time frame: Outcomes and Serious Adverse Events through Day 180
arm group label: Low dose cohort
arm group type: Experimental
description: SBI-101 device containing 250 million MSCs
arm group label: High dose cohort
arm group type: Experimental
description: SBI-101 device containing 750 million MSCs
arm group label: Case controls
arm group type: No Intervention
description: Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants.
intervention type: Biological
intervention name: SBI-101
description: SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
arm group label: High dose cohort
arm group label: Low dose cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No