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

NCT ID: NCT03051308

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-07-01

Brief Summary

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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

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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.

Conditions

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Parathyroid Allotransplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

NPT and UW Solution

Intervention Type COMBINATION_PRODUCT

Tissue preservation solutions for transplantation

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

Group Type EXPERIMENTAL

NPT and UW Solution

Intervention Type COMBINATION_PRODUCT

Tissue preservation solutions for transplantation

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

Group Type EXPERIMENTAL

NPT and UW Solution

Intervention Type COMBINATION_PRODUCT

Tissue preservation solutions for transplantation

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

Group Type EXPERIMENTAL

NPT and UW Solution

Intervention Type COMBINATION_PRODUCT

Tissue preservation solutions for transplantation

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

Group Type EXPERIMENTAL

NPT and UW Solution

Intervention Type COMBINATION_PRODUCT

Tissue preservation solutions for transplantation

Interventions

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NPT and UW Solution

Tissue preservation solutions for transplantation

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role collaborator

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erhan Aysan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erhan Aysan, Prof. M.D.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erhan Aysan, Prof. M.D.

Role: CONTACT

+902124531700 ext. 2465

Beyza Goncu, Msc

Role: CONTACT

+902124531700 ext. 1465

Facility Contacts

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Erhan Aysan, Prof. M.D.

Role: primary

+902124531700 ext. 2465

Beyza Goncu, Msc

Role: backup

+902124531700 ext. 1465

References

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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.

Reference Type BACKGROUND
PMID: 3282347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1689516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21566713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24311404 (View on PubMed)

Other Identifiers

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BAVUvsUW

Identifier Type: -

Identifier Source: org_study_id

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