<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/NCT02223117</url>
  </required_header>
  <id_info>
    <org_study_id>2011-1</org_study_id>
    <nct_id>NCT02223117</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)</brief_title>
  <official_title>Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cellphire Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Cellphire Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This &quot;first-in-human&quot; exploratory IND, single-center study will assess the safety, toxicity,&#xD;
      hematology, and immunogenicity of sub-therapeutic &quot;microdoses&quot; of autologous Thrombosomes® in&#xD;
      healthy human subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">July 21, 2016</completion_date>
  <primary_completion_date type="Actual">July 21, 2016</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety Evaluation</measure>
    <time_frame>60 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standard Hematology, Coagulation and Platelet Immunology Assessment</measure>
    <time_frame>60 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thrombosomes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Buffer/placebo Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Thrombosomes</intervention_name>
    <description>Freeze-dried platelets</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Buffer/placebo Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Minimum weight 110 pounds (50 kg)&#xD;
&#xD;
          2. Age 18-45 years&#xD;
&#xD;
          3. Able and willing to provide informed consent&#xD;
&#xD;
          4. Has permanent address and phone/e-mail for contact and notification, and able to come&#xD;
             to the research site for scheduled study visits for up to 60 days after their last&#xD;
             study infusion&#xD;
&#xD;
          5. Understands, speaks and reads standard English language&#xD;
&#xD;
          6. Normal healthy subject able to pass the universal blood donor history questionnaire&#xD;
             and screen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Breast-feeding female&#xD;
&#xD;
          2. At any time, previously pregnant female&#xD;
&#xD;
          3. Participation in an experimental drug/device study within the past 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Fitzpatrick, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cellphire Therapeutics, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sherrill Slichter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bloodworks Northwest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bloodworks Northwest</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>December 11, 2017</last_update_submitted>
  <last_update_submitted_qc>December 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02223117
org study id: 2011-1
nct id: NCT02223117
lead sponsor: 
collaborator: 
has dmc: Yes
This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity,
      hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in
      healthy human subjects.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants with Adverse Events as a Measure of Safety Evaluation
time frame: 60 days
measure: Standard Hematology, Coagulation and Platelet Immunology Assessment
time frame: 60 Days
arm group label: Intervention
arm group type: Experimental
description: Thrombosomes
arm group label: Placebo
arm group type: Placebo Comparator
description: Buffer/placebo Control
intervention type: Biological
intervention name: Thrombosomes
description: Freeze-dried platelets
arm group label: Intervention
intervention type: Biological
intervention name: Placebo
arm group label: Placebo
other name: Buffer/placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Fitzpatrick, PhD
role: Study Director
affiliation: Cellphire Therapeutics, Inc.
last name: Sherrill Slichter, MD
role: Principal Investigator
affiliation: Bloodworks Northwest
facility: 
country: United States
responsible party type: Sponsor