<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/NCT04429763</url>
  </required_header>
  <id_info>
    <org_study_id>202001</org_study_id>
    <nct_id>NCT04429763</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia</brief_title>
  <acronym>CELMA</acronym>
  <official_title>Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trustem</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación Universitaria de Ciencias de la Salud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de San Jose</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Infantil Universitario de San Jose</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trustem</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>
      The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a&#xD;
      worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a&#xD;
      little geographic area, that could surpase the resourses of the any health system in the&#xD;
      world.&#xD;
&#xD;
      There is no documentation of an effective alternative for the treatment of the severe ill&#xD;
      patients, that can reduce the mortality or the adverse events suffered by these people.&#xD;
&#xD;
      It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of&#xD;
      these patients, thanks to their direct and indirect antiviral capacity, and its potency as&#xD;
      immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objetive:&#xD;
&#xD;
      Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the&#xD;
      clinical progresion and mortality of hospitalized COVID-19 patients.&#xD;
&#xD;
      Metodology:&#xD;
&#xD;
      Fase II, controled clinical trial, double blinded, compared with placebo, with paralel&#xD;
      groups, and one to one asignation. It will be included patients between 18 and 79 years old,&#xD;
      hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis.&#xD;
      It will be excluded those who have indication for management in Intensive Care Unit, have any&#xD;
      condition that seriusly affect their survival, pregnant whomen or breast feeding, those who&#xD;
      have an advanced hearth failure, HIV infected, those who have a bacterial or fungal&#xD;
      uncontroled infection, those who require permanent immunosupresive therapy or have had an&#xD;
      organ trasplant, those who have no possibility to sign the informed consent format or are&#xD;
      involved in another clinical trial with drugs or interventions.&#xD;
&#xD;
      It will vinculate 30 patients randomly assigned, by centralized electronic assignation&#xD;
      sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human&#xD;
      umbilical cord or to placebo group.&#xD;
&#xD;
      The primary result it will be a composed point of time to the occurrence of the clinical&#xD;
      detriment or the death (the first that occurs) and the secondary result will be the&#xD;
      components of each primary point, the clinical recovery, the time to the time to the&#xD;
      discharge from the hospital, and the clinical follow-up, including respiratory function, and&#xD;
      markers of inflammation, haematological and kidney, in addition of the safety markers.&#xD;
&#xD;
      It will be done a comparison of the incidence rates, by ratio of incidence rates and their&#xD;
      respective confidence interval. It will be construct Kaplan-Meier curves that will compared&#xD;
      by the statics of logaritmic rank (log-rank test).&#xD;
&#xD;
      It will be developed a multivariate analysis, with the Cox proportional risks methodology,&#xD;
      estimating the Hazard Ratio epidemiologic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1*10^6 cells/Kg or placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical deterioration or death</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in two or more degrees in the NEWS scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual tratment for COVID-19 plus MSC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual treatment for COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Umbilical cord derived mesenchymal stem cells</intervention_name>
    <description>One dosis of 1*10^6 cells/Kg</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe COVID-19.&#xD;
&#xD;
          -  Infection confirmed by PCR test.&#xD;
&#xD;
          -  Hospitalized in general room (respiratory isolation area).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shock or multiorgan disfunction that require continous vital signs monitorization&#xD;
&#xD;
          -  Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.&#xD;
&#xD;
          -  Condition that seriously affects the patient survival expectancies, including any&#xD;
             active cancer, hemorragia, any blood disease or severe malnutrition.&#xD;
&#xD;
          -  Pregnant women or breast feeding.&#xD;
&#xD;
          -  Advanced hearth failure.&#xD;
&#xD;
          -  VIH/AIDS.&#xD;
&#xD;
          -  Bacterial or fungical uncontroled infection.&#xD;
&#xD;
          -  Permanente use of immunosupresants or have had received an organ trasnplanted in the&#xD;
             past six months.&#xD;
&#xD;
          -  Imposibility to sign the informent consent format.&#xD;
&#xD;
          -  Patients involved in another clinical trial with drugs or interventions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Sánchez-Vanegas, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fundación Universitaria de Ciencias de la Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Escobar-Soto, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Trustem</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jhon Jaime Sprockel Díaz, MD, Esp</last_name>
    <phone>+573538000</phone>
    <email>jjsprockel@fucsalud.edu.co</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolina Araque, MD, Esp</last_name>
    <phone>+574377540</phone>
    <email>caroaraque@gmail.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>Umbilical Cord</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/NCT04429763
org study id: 202001
nct id: NCT04429763
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a
      worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a
      little geographic area, that could surpase the resourses of the any health system in the
      world.

      There is no documentation of an effective alternative for the treatment of the severe ill
      patients, that can reduce the mortality or the adverse events suffered by these people.

      It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of
      these patients, thanks to their direct and indirect antiviral capacity, and its potency as
      immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
Objetive:

      Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the
      clinical progresion and mortality of hospitalized COVID-19 patients.

      Metodology:

      Fase II, controled clinical trial, double blinded, compared with placebo, with paralel
      groups, and one to one asignation. It will be included patients between 18 and 79 years old,
      hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis.
      It will be excluded those who have indication for management in Intensive Care Unit, have any
      condition that seriusly affect their survival, pregnant whomen or breast feeding, those who
      have an advanced hearth failure, HIV infected, those who have a bacterial or fungal
      uncontroled infection, those who require permanent immunosupresive therapy or have had an
      organ trasplant, those who have no possibility to sign the informed consent format or are
      involved in another clinical trial with drugs or interventions.

      It will vinculate 30 patients randomly assigned, by centralized electronic assignation
      sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human
      umbilical cord or to placebo group.

      The primary result it will be a composed point of time to the occurrence of the clinical
      detriment or the death (the first that occurs) and the secondary result will be the
      components of each primary point, the clinical recovery, the time to the time to the
      discharge from the hospital, and the clinical follow-up, including respiratory function, and
      markers of inflammation, haematological and kidney, in addition of the safety markers.

      It will be done a comparison of the incidence rates, by ratio of incidence rates and their
      respective confidence interval. It will be construct Kaplan-Meier curves that will compared
      by the statics of logaritmic rank (log-rank test).

      It will be developed a multivariate analysis, with the Cox proportional risks methodology,
      estimating the Hazard Ratio epidemiologic.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1*10^6 cells/Kg or placebo
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Clinical deterioration or death
time frame: 4 weeks
description: Change in two or more degrees in the NEWS scale
arm group label: Experimental
arm group type: Experimental
description: Usual tratment for COVID-19 plus MSC
arm group label: Control
arm group type: Placebo Comparator
description: Usual treatment for COVID-19
intervention type: Biological
intervention name: Umbilical cord derived mesenchymal stem cells
description: One dosis of 1*10^6 cells/Kg
arm group label: Experimental
intervention type: Biological
intervention name: Placebo
description: Placebo
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Guillermo Sánchez-Vanegas, MD, PhD
role: Study Chair
affiliation: Fundación Universitaria de Ciencias de la Salud
last name: Carlos Escobar-Soto, MD, PhD
role: Study Director
affiliation: Trustem
last name: Jhon Jaime Sprockel Díaz, MD, Esp
phone: +573538000
email: jjsprockel@fucsalud.edu.co
last name: Carolina Araque, MD, Esp
phone: +574377540
email: caroaraque@gmail.com
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No