An interventional study of NPT and UW Solution in Parathyroid Allotransplantation, sponsored by SB Istanbul Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-13.
Sponsored by SB Istanbul Education and Research Hospital · Not applicable, Interventional, and Basic science
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.
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.
SB Istanbul Education and Research Hospital is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hour
Parathormone Release of Parathyroid Cells
The investigators will measure the parathormone level from cultured parathyroid cells
Time frame: 1 day
Plan to share: Undecided
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SB Istanbul Education and Research Hospital