<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/NCT02978287</url>
  </required_header>
  <id_info>
    <org_study_id>BAVU Solusyon</org_study_id>
    <nct_id>NCT02978287</nct_id>
  </id_info>
  <brief_title>New Transporting Solution in Parathyroid Allotransplantation</brief_title>
  <official_title>The Effects of Cold Ischemia Time With a New Transporting Solution to Parathyroid Cell Viability and Calcium Sensing Receptor in Parathyroid Allotransplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to measure of the parathyroid cell viability and the the amount of&#xD;
      calcium sensing receptor of the parathyroid cells which were placed into a new transportation&#xD;
      solution (BAVU solution) for parathyroid allotransplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cold ischemia of organs, has harmful effects on the tissues due to oxidative stress and&#xD;
      inflammation. This is physiopathologically defined as ischaemia/re-perfusion injury (IRI) in&#xD;
      organ transplantation. Parathyroid allotransplantation has an increased popularity at the&#xD;
      last decade. But the cold ischemia due to transportation of the transplant tissue is a very&#xD;
      important problem.&#xD;
&#xD;
      Calcium sensing receptor plays a crucial role in regulating Parathormone secretion which&#xD;
      means controlling of the calcium-dependent systemic ion homeostasis.&#xD;
&#xD;
      The investigators developed a new tissue transporting solution for parathyroid&#xD;
      allotransplantation and the investigators measured the parathyroid cell viability and the the&#xD;
      amount of calcium sensing receptor of the parathyroid cells at the 0., 6., 12. and 24. hours&#xD;
      of the parathyroid cells which were placed into our new solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cell viability of Parathyroid cells</measure>
    <time_frame>0 hour</time_frame>
    <description>The investigators will measure the viability of Parathyroid cells at 0 hour at the BAVU solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cell viability of Parathyroid cells</measure>
    <time_frame>6 hours</time_frame>
    <description>The investigators will measure the viability of Parathyroid cells at 6 hours at the BAVU solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cell viability of Parathyroid cells</measure>
    <time_frame>12 hours</time_frame>
    <description>The investigators will measure the viability of Parathyroid cells at 12 hours at the BAVU solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cell viability of Parathyroid cells</measure>
    <time_frame>18 hours</time_frame>
    <description>The investigators will measure the viability of Parathyroid cells at 18 hours at the BAVU solution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cell viability of Parathyroid cells</measure>
    <time_frame>24 hours</time_frame>
    <description>The investigators will measure the viability of Parathyroid cells at 24 hours at the BAVU solution</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">7</enrollment>
  <condition>Parathyroid Allotransplantation</condition>
  <arm_group>
    <arm_group_label>BAVU Solution 0. hour (control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAVU Solution 6. hour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAVU Solution 12. hour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAVU Solution 18. hour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAVU Solution 24. hour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAVU Solution</intervention_name>
    <description>Tissue preservation solution for transplantation</description>
    <arm_group_label>BAVU Solution 12. hour</arm_group_label>
    <arm_group_label>BAVU Solution 18. hour</arm_group_label>
    <arm_group_label>BAVU Solution 24. hour</arm_group_label>
    <arm_group_label>BAVU Solution 6. hour</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have parathyroid hyperplasia due to chronic renal failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refused to join to the study&#xD;
&#xD;
          -  Patients younger than 18 years and older than 80 years.&#xD;
&#xD;
          -  Patients who have hepatitis B,&#xD;
&#xD;
          -  Patients who have hepatitis C,&#xD;
&#xD;
          -  Patients who have human immunodeficiency virus (HIV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Erhan Aysan, Prof. M.D.</last_name>
    <phone>+905322034879</phone>
    <email>erhanaysan@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ufuk Oguz Idiz, M.D.</last_name>
    <phone>+905062044714</phone>
    <email>oguzidiz@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bezmialem University</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erhan Aysan, Prof M.D.</last_name>
      <phone>+905322034879</phone>
      <email>erhanaysan@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ufuk Oguz Idiz, M.D.</last_name>
      <phone>+905062044714</phone>
      <email>oguzidiz@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Guibert EE, Petrenko AY, Balaban CL, Somov AY, Rodriguez JV, Fuller BJ. Organ Preservation: Current Concepts and New Strategies for the Next Decade. Transfus Med Hemother. 2011;38(2):125-142. doi: 10.1159/000327033. Epub 2011 Mar 21.</citation>
    <PMID>21566713</PMID>
  </results_reference>
  <results_reference>
    <citation>Hendy GN, Guarnieri V, Canaff L. Calcium-sensing receptor and associated diseases. Prog Mol Biol Transl Sci. 2009;89:31-95. doi: 10.1016/S1877-1173(09)89003-0. Epub 2009 Oct 7.</citation>
    <PMID>20374733</PMID>
  </results_reference>
  <results_reference>
    <citation>Voigt MR, DeLario GT. Perspectives on abdominal organ preservation solutions: a comparative literature review. Prog Transplant. 2013 Dec;23(4):383-91. doi: 10.7182/pit2013100.</citation>
    <PMID>24311404</PMID>
  </results_reference>
  <results_reference>
    <citation>Nawrot I, Wozniewicz B, Tolloczko T, Sawicki A, Gorski A, Chudzinski W, Wojtaszek M, Grzesiuk W, Sladowski D, Karwacki J, Zawitkowska T, Szmidt J. Allotransplantation of cultured parathyroid progenitor cells without immunosuppression: clinical results. Transplantation. 2007 Mar 27;83(6):734-40. doi: 10.1097/01.tp.0000258601.17505.9d.</citation>
    <PMID>17414706</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ufuk Oguz Idiz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Calcium sensing receptor</keyword>
  <keyword>Parathyroid cell viability</keyword>
  <keyword>Parathyroid allotransplantation</keyword>
  <keyword>Transporting solution</keyword>
  <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/NCT02978287
org study id: BAVU Solusyon
nct id: NCT02978287
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to measure of the parathyroid cell viability and the the amount of
      calcium sensing receptor of the parathyroid cells which were placed into a new transportation
      solution (BAVU solution) for parathyroid allotransplantation.
The cold ischemia of organs, has harmful effects on the tissues due to oxidative stress and
      inflammation. This is physiopathologically defined as ischaemia/re-perfusion injury (IRI) in
      organ transplantation. Parathyroid allotransplantation has an increased popularity at the
      last decade. But the cold ischemia due to transportation of the transplant tissue is a very
      important problem.

      Calcium sensing receptor plays a crucial role in regulating Parathormone secretion which
      means controlling of the calcium-dependent systemic ion homeostasis.

      The investigators developed a new tissue transporting solution for parathyroid
      allotransplantation and the investigators measured the parathyroid cell viability and the the
      amount of calcium sensing receptor of the parathyroid cells at the 0., 6., 12. and 24. hours
      of the parathyroid cells which were placed into our new solution.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cell viability of Parathyroid cells
time frame: 0 hour
description: The investigators will measure the viability of Parathyroid cells at 0 hour at the BAVU solution
measure: Cell viability of Parathyroid cells
time frame: 6 hours
description: The investigators will measure the viability of Parathyroid cells at 6 hours at the BAVU solution
measure: Cell viability of Parathyroid cells
time frame: 12 hours
description: The investigators will measure the viability of Parathyroid cells at 12 hours at the BAVU solution
measure: Cell viability of Parathyroid cells
time frame: 18 hours
description: The investigators will measure the viability of Parathyroid cells at 18 hours at the BAVU solution
measure: Cell viability of Parathyroid cells
time frame: 24 hours
description: The investigators will measure the viability of Parathyroid cells at 24 hours at the BAVU solution
arm group label: BAVU Solution 0. hour (control)
arm group type: No Intervention
description: Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour
arm group label: BAVU Solution 6. hour
arm group type: Experimental
description: Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour
arm group label: BAVU Solution 12. hour
arm group type: Experimental
description: Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour
arm group label: BAVU Solution 18. hour
arm group type: Experimental
description: Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour
arm group label: BAVU Solution 24. hour
arm group type: Experimental
description: Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour
intervention type: Drug
intervention name: BAVU Solution
description: Tissue preservation solution for transplantation
arm group label: BAVU Solution 12. hour
arm group label: BAVU Solution 18. hour
arm group label: BAVU Solution 24. hour
arm group label: BAVU Solution 6. hour
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Erhan Aysan, Prof. M.D.
phone: +905322034879
email: erhanaysan@hotmail.com
last name: Ufuk Oguz Idiz, M.D.
phone: +905062044714
email: oguzidiz@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Guibert EE, Petrenko AY, Balaban CL, Somov AY, Rodriguez JV, Fuller BJ. Organ Preservation: Current Concepts and New Strategies for the Next Decade. Transfus Med Hemother. 2011;38(2):125-142. doi: 10.1159/000327033. Epub 2011 Mar 21.
PMID: 21566713
citation: Hendy GN, Guarnieri V, Canaff L. Calcium-sensing receptor and associated diseases. Prog Mol Biol Transl Sci. 2009;89:31-95. doi: 10.1016/S1877-1173(09)89003-0. Epub 2009 Oct 7.
PMID: 20374733
citation: Voigt MR, DeLario GT. Perspectives on abdominal organ preservation solutions: a comparative literature review. Prog Transplant. 2013 Dec;23(4):383-91. doi: 10.7182/pit2013100.
PMID: 24311404
citation: Nawrot I, Wozniewicz B, Tolloczko T, Sawicki A, Gorski A, Chudzinski W, Wojtaszek M, Grzesiuk W, Sladowski D, Karwacki J, Zawitkowska T, Szmidt J. Allotransplantation of cultured parathyroid progenitor cells without immunosuppression: clinical results. Transplantation. 2007 Mar 27;83(6):734-40. doi: 10.1097/01.tp.0000258601.17505.9d.
PMID: 17414706
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Ufuk Oguz Idiz
investigator title: Principal Investigator
sharing ipd: No