<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/NCT03762512</url>
  </required_header>
  <id_info>
    <org_study_id>MNV-PLC-1</org_study_id>
    <nct_id>NCT03762512</nct_id>
  </id_info>
  <brief_title>Collection of Placenta for Mitochondria Isolation</brief_title>
  <official_title>Collection of Placenta for Mitochondria Isolation for Use in Mitochondrial Augmentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minovia Therapeutics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minovia Therapeutics Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will&#xD;
      be used in mitochondrial augmentation therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Placenta donated</measure>
    <time_frame>immediate</time_frame>
    <description>The purpose of this study is to collect placenta for the production of mitochondria. Therefore, only general measurements are taken such as placenta weight and health of mother during pregnancy. No further intervention or interaction with the mother will occur, and she does not receive any drug product or treatment prior to or after placenta donation.</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pregnancy Related</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant females giving term birth by C-section&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females, singleton pregnancy&#xD;
&#xD;
          -  Planned elective C-section&#xD;
&#xD;
          -  uncomplicated pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Donor positive for viruses tested&#xD;
&#xD;
          -  Donor excessive smoker or drinker&#xD;
&#xD;
          -  Donor known to carry mitochondrial disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Must be pregnant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Diana Chigalayev</last_name>
    <phone>+972544880543</phone>
    <email>Diana.Chigalayev@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical Center Hospital- Tel Hashomer</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diana Chigalayev</last_name>
      <phone>972-3-5307145</phone>
      <email>diana.chigalayev@sheba.gov.il</email>
    </contact>
    <contact_backup>
      <last_name>Elad Jacobi, MD</last_name>
      <phone>972-3-5303037</phone>
      <email>elad.jacoby@sheba.gov.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03762512
org study id: MNV-PLC-1
nct id: NCT03762512
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will
      be used in mitochondrial augmentation therapy.
observational model: Case-Only
time perspective: Prospective
measure: Placenta donated
time frame: immediate
description: The purpose of this study is to collect placenta for the production of mitochondria. Therefore, only general measurements are taken such as placenta weight and health of mother during pregnancy. No further intervention or interaction with the mother will occur, and she does not receive any drug product or treatment prior to or after placenta donation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Must be pregnant
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diana Chigalayev
phone: +972544880543
email: Diana.Chigalayev@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor
sharing ipd: No