<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/NCT03027232</url>
  </required_header>
  <id_info>
    <org_study_id>2007P000215</org_study_id>
    <nct_id>NCT03027232</nct_id>
  </id_info>
  <brief_title>Control of Leukocyte Function</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The&#xD;
      aims of these in vitro studies are to determine the cellular and intracellular mechanisms by&#xD;
      which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proper regulation of leukocyte function is critical for immune defense and to prevent&#xD;
      autoimmune diseases. Many aspects of immune cell regulation are unknown. A better&#xD;
      understanding could lead to novel therapeutic approaches to improve immune function in&#xD;
      patients suffering from various diseases.&#xD;
&#xD;
      The investigators have found that hypertonic conditions regulate leukocyte functions through&#xD;
      feedback mechanisms involving ATP release and purinergic receptors. The purpose of the&#xD;
      proposed protocol is to obtain access to peripheral blood from healthy volunteers to study&#xD;
      these complex regulatory mechanisms in more detail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.</measure>
    <time_frame>Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.</time_frame>
    <description>The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Inflammation, Brain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies</intervention_name>
    <description>No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood is collected from all subjects in the same fashion. Purpose: isolation of immune cells&#xD;
      for in vitro studies of cell function.&#xD;
&#xD;
      This is an observational study in human beings in predefined groups of individuals who are&#xD;
      healthy and volunteer to donate blood for laboratory science studies. Subjects in the study&#xD;
      receive neither diagnostic, therapeutic, nor other interventions, and the investigator does&#xD;
      not assign specific interventions to any of the subjects of the study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any healthy volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  needing/using drugs&#xD;
&#xD;
          -  inflammatory or infectious complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BIDMC</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Wolfgang Junger</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Inflammation</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/NCT03027232
org study id: 2007P000215
nct id: NCT03027232
lead sponsor: 
has dmc: No
The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The
      aims of these in vitro studies are to determine the cellular and intracellular mechanisms by
      which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.
The proper regulation of leukocyte function is critical for immune defense and to prevent
      autoimmune diseases. Many aspects of immune cell regulation are unknown. A better
      understanding could lead to novel therapeutic approaches to improve immune function in
      patients suffering from various diseases.

      The investigators have found that hypertonic conditions regulate leukocyte functions through
      feedback mechanisms involving ATP release and purinergic receptors. The purpose of the
      proposed protocol is to obtain access to peripheral blood from healthy volunteers to study
      these complex regulatory mechanisms in more detail.
observational model: Other
time perspective: Other
measure: Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.
time frame: Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.
description: The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.
intervention type: Other
intervention name: No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies
description: No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.
Blood is collected from all subjects in the same fashion. Purpose: isolation of immune cells
      for in vitro studies of cell function.

      This is an observational study in human beings in predefined groups of individuals who are
      healthy and volunteer to donate blood for laboratory science studies. Subjects in the study
      receive neither diagnostic, therapeutic, nor other interventions, and the investigator does
      not assign specific interventions to any of the subjects of the study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Wolfgang Junger
investigator title: Professor of Surgery
mesh term: Encephalitis
mesh term: Inflammation
sharing ipd: No