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

NCT03051308 — Not applicable, Unknown, 7 participants, SB Istanbul Education and Research Hospital

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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

Registry	NCT03051308
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	7 (Estimated)
Sponsor	SB Istanbul Education and Research Hospital (Other); collaborators: Bezmialem Vakif University
Conditions	Parathyroid Allotransplantation
Interventions	NPT and UW Solution (Combination product)
Dates	start 2017-03-01 (estimated), primary completion 2017-06-01 (estimated), completion 2017-07-01 (estimated), first posted 2017-02-13, last updated 2017-02-13
Locations	1 site in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
First Application in Hour 0	Experimental	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 0' non-cold ischemia tissue group
First Application in Hour 6	Experimental	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
First Application in Hour 12	Experimental	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
First Application in Hour 18	Experimental	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
First Application in Hour 24	Experimental	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

NPT and UW Solution (Combination product): Tissue preservation solutions for transplantation

+Outcome measures

Primary outcomes

Cell viability of Parathyroid cells after isolation process [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 6 hour of cold ischemia [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 12 hour of cold ischemia [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 [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 24 hour of cold ischemia [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]: The investigators will measure the parathormone level from cultured parathyroid cells

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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).

+Locations (1)

Facility	City	Country	Status
Bezmialem Vakif University Hospital	Istanbul	Turkey (Türkiye)	Recruiting

+Publications

Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available. PMID 3282347
Southard JH, van Gulik TM, Ametani MS, Vreugdenhil PK, Lindell SL, Pienaar BL, Belzer FO. Important components of the UW solution. Transplantation. 1990 Feb;49(2):251-7. doi: 10.1097/00007890-199002000-00004. PMID 1689516
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
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

+Investigators

Erhan Aysan, Prof. M.D., Study director, Bezmialem Vakif University