<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/NCT04473170</url>
  </required_header>
  <id_info>
    <org_study_id>CT.001.1.0.SENTAD-COVID</org_study_id>
    <nct_id>NCT04473170</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19</brief_title>
  <acronym>SENTAD-COVID</acronym>
  <official_title>Adaptive Open-label Study Evaluating the Safety and Efficacy of Autologous Non- Hematopoietic Peripheral Blood Stem Cells Therapy in COVID-19 Outbreak in Abu Dhabi, 2020 (SENTAD-COVID Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abu Dhabi Stem Cells Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abu Dhabi Stem Cells Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized&#xD;
      controlled clinical trial involving hospitalized adult patients with confirmed coronavirus&#xD;
      disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were&#xD;
      randomly allocated in a parallel assignment involving two groups of participants: Group A&#xD;
      (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy&#xD;
      as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19&#xD;
      standard care. Standard care is defined as per the &quot;UAE National Guidelines for Clinical&#xD;
      Management and Treatment of COVID-19&quot;. SENTAD-COVID Study was conducted in the Sheikh Khalifa&#xD;
      Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell&#xD;
      processing and investigational product formulation were completed by Abu Dhabi Stem Cells&#xD;
      Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing&#xD;
      Practices (GMPs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Group A patients received autologous NHPBSC therapy through jet nebulization, in addition to&#xD;
      the standard care, while Group B (No investigational intervention arm) received only the UAE&#xD;
      approved standard care. The primary endpoints were the safety and efficacy assessment,&#xD;
      measured as Adverse Reactions (ARs) incidence [according to World Health Organization -&#xD;
      Uppsala Monitoring Centre (WHO-UMC) causality assessment system], rate of mortality within&#xD;
      28-days, and the time to clinical improvement of 2 points on a seven-category ordinal scale&#xD;
      or discharge from the Hospital, whichever came first. Immune response profile, acute-phase&#xD;
      serum markers, and coagulation testing profile were evaluated as well, before treatment&#xD;
      (baseline - Day 0), at Day 14, and Day 21 (in patients with early response, defined as 2&#xD;
      points of difference in the clinical critical treatment index within 7 days of treatment, the&#xD;
      assessment will be performed at Day 7). The trial was approved by the institutional ADSCC&#xD;
      Research Ethics Committees (REC), and the Emirates Institutional Review Board (IRB) for&#xD;
      COVID-19 Research and the written informed consent was obtained from all patients or from the&#xD;
      patient's legal representative if the patient was too unwell to provide consent. SENTAD-COVID&#xD;
      Study was conducted in accordance with the principles of the Declaration of Helsinki and the&#xD;
      Good Clinical Practice (GCP) Guidelines of the International Conference on Harmonization&#xD;
      (ICH). The authors were responsible for designing the trial and for compiling and analyzing&#xD;
      the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2020</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</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>
    <intervention_model_description>Parallel assignment involving two groups of participants:&#xD;
Group A (Experimental arm): Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.&#xD;
Group B (No investigational intervention arm): COVID-19 standard care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>None (open-label)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse reactions incidence.</measure>
    <time_frame>Day 0 - 28</time_frame>
    <description>Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of mortality within 28-days.</measure>
    <time_frame>Day 0 - 28</time_frame>
    <description>Incidence of deaths within 28-days in enrolled patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to clinical improvement on a seven-category ordinal scale.</measure>
    <time_frame>Day 0 - 28</time_frame>
    <description>Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the immune response profile.</measure>
    <time_frame>Days 0, 14, and 28</time_frame>
    <description>Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of acute-phase serum markers.</measure>
    <time_frame>Days 0, 14, and 28</time_frame>
    <description>Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Coronavirus Disease 2019 (COVID-19)</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>COVID-19 Standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)</intervention_name>
    <description>SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>UAECell19</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COVID-19 standard care</intervention_name>
    <description>UAE National Guidelines for Clinical Management and Treatment of COVID-19.</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Current COVID-19 standard care in the UAE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RT-PCR Laboratory confirmation of COVID-19.&#xD;
&#xD;
          -  Male or female aged ≥ 18 years.&#xD;
&#xD;
          -  Interstitial lung change ≥ 3 judged by &quot;Lungs Lobar based scoring&quot; according to&#xD;
             computed tomography (CT) scans.&#xD;
&#xD;
          -  Hospitalized and symptomatic patients, referring one or more of the following symptoms&#xD;
             (fever, cough, or shortness of breath), in association with (at least one): tiredness,&#xD;
             runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or&#xD;
             smell).&#xD;
&#xD;
          -  Ability to comply with test requirements and peripheral blood stem cells collection.&#xD;
&#xD;
          -  The patient or legal representative agrees to participate in the study, and signs the&#xD;
             SENTAD-COVID Study informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (aged &lt; 18 years).&#xD;
&#xD;
          -  Diagnosis of any kind of shock.&#xD;
&#xD;
          -  Organ transplants in the past 3 months.&#xD;
&#xD;
          -  Patients receiving immunosuppressive therapy.&#xD;
&#xD;
          -  Diagnostic of Hepatitis B Virus (HBV) infection.&#xD;
&#xD;
          -  Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired&#xD;
             Immunodeficiency Syndrome (AIDS).&#xD;
&#xD;
          -  Current diagnosis of cancer.&#xD;
&#xD;
          -  History of malignancies in the past 5 years.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Have participated in other clinical trials in the past 3 months.&#xD;
&#xD;
          -  Inability to comply with test requirements and peripheral blood stem cells collection.&#xD;
&#xD;
          -  Inability to provide informed consent.&#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>Yendry Ventura Carmenate, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abu Dhabi Stem Cells Center (ADSCC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abu Dhabi Stem Cells Center</name>
      <address>
        <city>Abu Dhabi</city>
        <zip>4600</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Non-Hematopoietic Peripheral Blood Stem Cells</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/NCT04473170
org study id: CT.001.1.0.SENTAD-COVID
nct id: NCT04473170
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized
      controlled clinical trial involving hospitalized adult patients with confirmed coronavirus
      disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were
      randomly allocated in a parallel assignment involving two groups of participants: Group A
      (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy
      as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19
      standard care. Standard care is defined as per the "UAE National Guidelines for Clinical
      Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa
      Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell
      processing and investigational product formulation were completed by Abu Dhabi Stem Cells
      Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing
      Practices (GMPs).
Group A patients received autologous NHPBSC therapy through jet nebulization, in addition to
      the standard care, while Group B (No investigational intervention arm) received only the UAE
      approved standard care. The primary endpoints were the safety and efficacy assessment,
      measured as Adverse Reactions (ARs) incidence [according to World Health Organization -
      Uppsala Monitoring Centre (WHO-UMC) causality assessment system], rate of mortality within
      28-days, and the time to clinical improvement of 2 points on a seven-category ordinal scale
      or discharge from the Hospital, whichever came first. Immune response profile, acute-phase
      serum markers, and coagulation testing profile were evaluated as well, before treatment
      (baseline - Day 0), at Day 14, and Day 21 (in patients with early response, defined as 2
      points of difference in the clinical critical treatment index within 7 days of treatment, the
      assessment will be performed at Day 7). The trial was approved by the institutional ADSCC
      Research Ethics Committees (REC), and the Emirates Institutional Review Board (IRB) for
      COVID-19 Research and the written informed consent was obtained from all patients or from the
      patient's legal representative if the patient was too unwell to provide consent. SENTAD-COVID
      Study was conducted in accordance with the principles of the Declaration of Helsinki and the
      Good Clinical Practice (GCP) Guidelines of the International Conference on Harmonization
      (ICH). The authors were responsible for designing the trial and for compiling and analyzing
      the data.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment involving two groups of participants:
Group A (Experimental arm): Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.
Group B (No investigational intervention arm): COVID-19 standard care.
primary purpose: Treatment
masking: None (Open Label)
masking description: None (open-label)
measure: Adverse reactions incidence.
time frame: Day 0 - 28
description: Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.
measure: Rate of mortality within 28-days.
time frame: Day 0 - 28
description: Incidence of deaths within 28-days in enrolled patients.
measure: Time to clinical improvement on a seven-category ordinal scale.
time frame: Day 0 - 28
description: Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.
measure: Assessment of the immune response profile.
time frame: Days 0, 14, and 28
description: Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.
measure: Assessment of acute-phase serum markers.
time frame: Days 0, 14, and 28
description: Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.
arm group label: Group A
arm group type: Experimental
description: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.
arm group label: Group B
arm group type: Active Comparator
description: COVID-19 Standard care.
intervention type: Biological
intervention name: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)
description: SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.
arm group label: Group A
other name: UAECell19
intervention type: Drug
intervention name: COVID-19 standard care
description: UAE National Guidelines for Clinical Management and Treatment of COVID-19.
arm group label: Group B
other name: Current COVID-19 standard care in the UAE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yendry Ventura Carmenate, M.D.
role: Principal Investigator
affiliation: Abu Dhabi Stem Cells Center (ADSCC)
facility: 
country: United Arab Emirates
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No