<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/NCT03015623</url>
  </required_header>
  <id_info>
    <org_study_id>SBI-101-01</org_study_id>
    <nct_id>NCT03015623</nct_id>
  </id_info>
  <brief_title>A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy</brief_title>
  <official_title>A Multi-center, Randomized, Sham-controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in Subjects With Acute Kidney Injury Receiving Continuous 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 Acute Kidney Injury (AKI) who require continuous renal&#xD;
      replacement therapy. SBI-101 is a biologic/device combination product designed to regulate&#xD;
      inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal&#xD;
      cells.&#xD;
&#xD;
      The study will be conducted in two cohorts, with an interim analysis performed in between the&#xD;
      cohorts. In the first cohort, subjects will be randomized to receive one of two treatments -&#xD;
      low dose SBI-101 or sham control. In the second cohort, subjects will be randomized to&#xD;
      receive one of two treatments - high dose SBI-101 or sham control. SBI-101 or sham control&#xD;
      will be integrated into the renal replacement circuit and subjects in both cohorts will be&#xD;
      treated for up to 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">June 20, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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 out to Day 28 and Serious Adverse Events through Day 180</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Acute Kidney Injury</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>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham device containing no MSCs</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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AKI, as determined by the Investigator based on his/her clinical judgment&#xD;
&#xD;
          -  Able to tolerate indwelling intravascular access&#xD;
&#xD;
          -  Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP&#xD;
             treatment&#xD;
&#xD;
          -  Likely to require Continuous Renal Replacement Therapy for at least an additional 48&#xD;
             hours&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subjects who are pregnant, planning to become pregnant, or lactating&#xD;
&#xD;
          -  Known end-stage liver disease&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
&#xD;
          -  Acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis;&#xD;
             membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis);&#xD;
             acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or&#xD;
             hereditary renal disease (e.g. Alport's Syndrome; polycystic kidney disease)&#xD;
&#xD;
          -  AKI due to post-renal outflow obstruction&#xD;
&#xD;
          -  Acute or chronic vasculitis of any etiology&#xD;
&#xD;
          -  At the time of randomization, clinical evidence (e.g. febrile) suggestive of an&#xD;
             uncontrolled or inadequately treated systemic infection&#xD;
&#xD;
          -  History of a chronic systemic infection of any etiology regardless of therapy&#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&#xD;
&#xD;
          -  Systemic immunosuppressive therapy that has not been stabilized for greater than 4&#xD;
             months, or in the case of chronic corticosteroid therapy, a dose of &gt;15 mg/day of&#xD;
             prednisone or the equivalent within the past 30 days&#xD;
&#xD;
          -  Organ failure affecting more than 2 non-renal organs&#xD;
&#xD;
          -  Platelet count &lt;25,000/uL or other serious hematological abnormalities that would&#xD;
             place subject in imminent danger of death&#xD;
&#xD;
          -  Any prior medical condition 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>
  <overall_official>
    <last_name>Brian Miller</last_name>
    <role>Study Chair</role>
    <affiliation>Sentien Biotechnologies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mesenchymal stromal cells</keyword>
  <keyword>MSC</keyword>
  <keyword>Stem cells</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03015623
org study id: SBI-101-01
nct id: NCT03015623
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 Acute Kidney Injury (AKI) who require continuous renal
      replacement therapy. SBI-101 is a biologic/device combination product designed to regulate
      inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal
      cells.

      The study will be conducted in two cohorts, with an interim analysis performed in between the
      cohorts. In the first cohort, subjects will be randomized to receive one of two treatments -
      low dose SBI-101 or sham control. In the second cohort, subjects will be randomized to
      receive one of two treatments - high dose SBI-101 or sham control. SBI-101 or sham control
      will be integrated into the renal replacement circuit and subjects in both cohorts 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 out to Day 28 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: Control
arm group type: Sham Comparator
description: Sham device containing no MSCs
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
intervention type: Device
intervention name: Sham
description: The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Miller
role: Study Chair
affiliation: Sentien Biotechnologies, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No