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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia

Conditions
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Parathyroid Allotransplantation

Intervention / Treatment
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* Combination Product: NPT and UW Solution


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Application in Hour 0<br>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<br>* Tissue preservation solutions for transplantation<br>|
| Experimental: First Application in Hour 6<br>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<br>* Tissue preservation solutions for transplantation<br>|
| Experimental: First Application in Hour 12<br>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<br>* Tissue preservation solutions for transplantation<br>|
| Experimental: First Application in Hour 18<br>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<br>* Tissue preservation solutions for transplantation<br>|
| Experimental: First Application in Hour 24<br>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<br>* Tissue preservation solutions for transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell viability of Parathyroid cells after isolation process | 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. | 0 hour | 
| Cell viability of Parathyroid cells after 6 hour of cold ischemia | 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. | 6 hour | 
| Cell viability of Parathyroid cells after 12 hour of cold ischemia | 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. | 12 hour | 
| Cell viability of Parathyroid cells after 18 hour of cold ischemia | 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. | 18 hour | 
| Cell viability of Parathyroid cells after 24 hour of cold ischemia | 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. | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathormone Release of Parathyroid Cells | The investigators will measure the parathormone level from cultured parathyroid cells | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia, Parathyroid allotransplantation, Vitamin D Receptor, Calcium Sensing Receptor, Parathyroid cell viability