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University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051308
Recruitment Status : Unknown
Verified February 2017 by Erhan Aysan, SB Istanbul Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Bezmialem Vakif University
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital

Brief Summary:
Compare the functionality of new parathyroid transport solution (NPTS) with University of Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability, parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR) levels during cold ischemia.

Condition or disease Intervention/treatment Phase
Parathyroid Allotransplantation Combination Product: NPT and UW Solution Not Applicable

Detailed Description:

Parathormone (PTH) and vitamin D are two critical hormonal regulators of calcium homeostasis. There is an important relationship between the PTH release and vitamin D receptor for controlling hormonal systems. Also calcium-sensing receptor plays a crucial role in regulating parathormone secretion which means controlling the calcium-dependent systemic ion homeostasis.

Cold ischemia protects organs and tissues by slowing their metabolism. The cold ischemia of the transplant tissue is a very important process. The University of Wisconsin (UW) solution substantially improves graft preservation and consequently increases patient survival. The researchers newly developed NPTS for transportation of parathyroid glands.

For the comparision the researchers measured the parathyroid cell viability and the calcium sensing and vitamin D receptor density of the parathyroid cells at the 0, 6, 12 and 24 hours of cold ischemia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: First Application in Hour 0
Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10^7 cells) at 'First Application in Hour 0' non-cold ischemia tissue group
Combination Product: NPT and UW Solution
Tissue preservation solutions for transplantation

Experimental: First Application in Hour 6
Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10^7 cells) at 'First Application in Hour 6' cold ischemic tissue group
Combination Product: NPT and UW Solution
Tissue preservation solutions for transplantation

Experimental: First Application in Hour 12
Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10^7 cells) at 'First Application in Hour 12' cold ischemic tissue group
Combination Product: NPT and UW Solution
Tissue preservation solutions for transplantation

Experimental: First Application in Hour 18
Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10^7 cells) at 'First Application in Hour 18' cold ischemic tissue group
Combination Product: NPT and UW Solution
Tissue preservation solutions for transplantation

Experimental: First Application in Hour 24
Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10^7 cells) at 'First Application in Hour' 24 cold ischemic tissue group
Combination Product: NPT and UW Solution
Tissue preservation solutions for transplantation




Primary Outcome Measures :
  1. Cell viability of Parathyroid cells after isolation process [ Time Frame: 0 hour ]

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory.

    Then the investigators will measure the viability of Parathyroid cells after isolation process.


  2. Cell viability of Parathyroid cells after 6 hour of cold ischemia [ Time Frame: 6 hour ]
    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 6 hours the investigators will measure the viability of Parathyroid cells after isolation process.

  3. Cell viability of Parathyroid cells after 12 hour of cold ischemia [ Time Frame: 12 hour ]
    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 12 hours the investigators will measure the viability of Parathyroid cells after isolation process.

  4. Cell viability of Parathyroid cells after 18 hour of cold ischemia [ Time Frame: 18 hour ]
    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 18 hours the investigators will measure the viability of Parathyroid cells after isolation process.

  5. Cell viability of Parathyroid cells after 24 hour of cold ischemia [ Time Frame: 24 hour ]
    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 24 hours the investigators will measure the viability of Parathyroid cells after isolation process.


Secondary Outcome Measures :
  1. Parathormone Release of Parathyroid Cells [ Time Frame: 1 day ]
    The investigators will measure the parathormone level from cultured parathyroid cells



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have parathyroid hyperplasia due to chronic renal failure.

Exclusion Criteria:

  • Patients who refused to join the study
  • Patients younger than 18 years and older than 80 years.
  • Patients who have hepatitis B,
  • Patients who have hepatitis C,
  • Patients who have human immunodeficiency virus (HIV).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051308


Contacts
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Contact: Erhan Aysan, Prof. M.D. +902124531700 ext 2465 erhanaysan@hotmail.com
Contact: Beyza Goncu, Msc +902124531700 ext 1465 bsgoncu@gmail.com

Locations
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Turkey
Bezmialem Vakif University Hospital Recruiting
Istanbul, Turkey, 34093
Contact: Erhan Aysan, Prof. M.D.    +902124531700 ext 2465    erhanaysan@hotmail.com   
Contact: Beyza Goncu, Msc    +902124531700 ext 1465    bsgoncu@gmail.com   
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Bezmialem Vakif University
Investigators
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Study Director: Erhan Aysan, Prof. M.D. Bezmialem Vakif University
Publications:
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Responsible Party: Erhan Aysan, Principal Investigator, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03051308    
Other Study ID Numbers: BAVUvsUW
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erhan Aysan, SB Istanbul Education and Research Hospital:
Parathyroid cell viability
Ischemia
Parathyroid allotransplantation
Vitamin D Receptor
Calcium Sensing Receptor