Clinical trial NCT02978287: New Transporting Solution in Parathyroid Allotransplantation
Official title: The Effects of Cold Ischemia Time With a New Transporting Solution to Parathyroid Cell Viability and Calcium Sensing Receptor in Parathyroid Allotransplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parathyroid Allotransplantation
Keywords: Calcium sensing receptor
Parathyroid cell viability
Parathyroid allotransplantation
Transporting solution
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2016-11-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to measure of the parathyroid cell viability and the the amount of calcium sensing receptor of the parathyroid cells which were placed into a new transportation solution (BAVU solution) for parathyroid allotransplantation.

Detailed description: The cold ischemia of organs, has harmful effects on the tissues due to oxidative stress and inflammation. This is physiopathologically defined as ischaemia/re-perfusion injury (IRI) in organ transplantation. Parathyroid allotransplantation has an increased popularity at the last decade. But the cold ischemia due to transportation of the transplant tissue is a very important problem.

Calcium sensing receptor plays a crucial role in regulating Parathormone secretion which means controlling of the calcium-dependent systemic ion homeostasis.

The investigators developed a new tissue transporting solution for parathyroid allotransplantation and the investigators measured the parathyroid cell viability and the the amount of calcium sensing receptor of the parathyroid cells at the 0., 6., 12. and 24. hours of the parathyroid cells which were placed into our new solution.

Eligibility criteria: Inclusion Criteria:

* Patients who have parathyroid hyperplasia due to chronic renal failure

Exclusion Criteria:

* Patients who refused to join to 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
timeFrame: 0 hour
measure: Cell viability of Parathyroid cells
timeFrame: 6 hours
measure: Cell viability of Parathyroid cells
timeFrame: 12 hours
measure: Cell viability of Parathyroid cells
timeFrame: 18 hours
measure: Cell viability of Parathyroid cells
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
Study officials:
References:
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: Hendy GN, Guarnieri V, Canaff L. Calcium-sensing receptor and associated diseases. Prog Mol Biol Transl Sci. 2009;89:31-95. doi: 10.1016/S1877-1173(09)89003-0. Epub 2009 Oct 7.
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.
citation: Nawrot I, Wozniewicz B, Tolloczko T, Sawicki A, Gorski A, Chudzinski W, Wojtaszek M, Grzesiuk W, Sladowski D, Karwacki J, Zawitkowska T, Szmidt J. Allotransplantation of cultured parathyroid progenitor cells without immunosuppression: clinical results. Transplantation. 2007 Mar 27;83(6):734-40. doi: 10.1097/01.tp.0000258601.17505.9d.