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

SB Istanbul Education and Research Hospital

Status: Unknown

Conditions: Parathyroid Allotransplantation

Treatments: Combination Product: NPT and UW Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03051308

BAVUvsUW

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 5 patient groups

First Application in Hour 0

Experimental group

Description:

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

Treatment:

Combination Product: NPT and UW Solution

First Application in Hour 6

Experimental group

Description:

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

Treatment:

Combination Product: NPT and UW Solution

First Application in Hour 12

Experimental group

Description:

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

Treatment:

Combination Product: NPT and UW Solution

First Application in Hour 18

Experimental group

Description:

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

Treatment:

Combination Product: NPT and UW Solution

First Application in Hour 24

Experimental group

Description:

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

Treatment:

Combination Product: NPT and UW Solution