University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Cell viability of Parathyroid cells after isolation process
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
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.
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.
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.
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 Outcomes
- Parathormone Release of Parathyroid Cells(1 day)
Investigators
Erhan Aysan
Principal Investigator
SB Istanbul Education and Research Hospital