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

University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia

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.

Study Overview

• Status: Unknown
• Conditions: Parathyroid Allotransplantation
• Intervention / Treatment: Combination product: NPT and UW Solution

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 Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erhan Aysan, Prof. M.D.; Phone Number: 2465 +902124531700; Email: erhanaysan@hotmail.com
• Study Contact Backup: Name: Beyza Goncu, Msc; Phone Number: 1465 +902124531700; Email: bsgoncu@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Recruiting
    • Bezmialem Vakif University Hospital
    • Contact: Erhan Aysan, Prof. M.D.; Phone Number: 2465 +902124531700; Email: erhanaysan@hotmail.com
    • Contact: Beyza Goncu, Msc; Phone Number: 1465 +902124531700; Email: bsgoncu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First Application in Hour 0; 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; Tissue preservation solutions for transplantation
Experimental: First Application in Hour 6; 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; Tissue preservation solutions for transplantation
Experimental: First Application in Hour 12; 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; Tissue preservation solutions for transplantation
Experimental: First Application in Hour 18; 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; Tissue preservation solutions for transplantation
Experimental: First Application in Hour 24; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parathormone Release of Parathyroid Cells	The investigators will measure the parathormone level from cultured parathyroid cells	1 day

Collaborators and Investigators

• Sponsor: SB Istanbul Education and Research Hospital
• Collaborators: Bezmialem Vakif University
• Investigators: Study Director: Erhan Aysan, Prof. M.D., Bezmialem Vakif University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Ischemia; Parathyroid cell viability; Parathyroid allotransplantation; Vitamin D Receptor; Calcium Sensing Receptor
• Other Study ID Numbers: BAVUvsUW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No