Clinical trial NCT03051308: University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parathyroid Allotransplantation
Keywords: Parathyroid cell viability
Ischemia
Parathyroid allotransplantation
Vitamin D Receptor
Calcium Sensing Receptor
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2017-02-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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).

Primary outcomes:
measure: Cell viability of Parathyroid cells after isolation process
timeFrame: 0 hour
measure: Cell viability of Parathyroid cells after 6 hour of cold ischemia
timeFrame: 6 hour
measure: Cell viability of Parathyroid cells after 12 hour of cold ischemia
timeFrame: 12 hour
measure: Cell viability of Parathyroid cells after 18 hour of cold ischemia
timeFrame: 18 hour
measure: Cell viability of Parathyroid cells after 24 hour of cold ischemia
timeFrame: 24 hour
Secondary outcomes:
measure: Parathormone Release of Parathyroid Cells
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
affiliation: Bezmialem Vakif University
name: Erhan Aysan, Prof. M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.