New Transporting Solution in Parathyroid Allotransplantation
November 29, 2016 updated by: Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
The Effects of Cold Ischemia Time With a New Transporting Solution to Parathyroid Cell Viability and Calcium Sensing Receptor in Parathyroid Allotransplantation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34093
- Recruiting
- Bezmialem University
-
Contact:
- Ufuk Oguz Idiz, M.D.
- Phone Number: +905062044714
- Email: oguzidiz@hotmail.com
-
Contact:
- Erhan Aysan, Prof M.D.
- Phone Number: +905322034879
- Email: erhanaysan@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: BAVU Solution 0. hour (control)
Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour
|
|
|
EXPERIMENTAL: BAVU Solution 6. hour
Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour
|
Tissue preservation solution for transplantation
|
|
EXPERIMENTAL: BAVU Solution 12. hour
Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour
|
Tissue preservation solution for transplantation
|
|
EXPERIMENTAL: BAVU Solution 18. hour
Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour
|
Tissue preservation solution for transplantation
|
|
EXPERIMENTAL: BAVU Solution 24. hour
Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour
|
Tissue preservation solution for transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cell viability of Parathyroid cells
Time Frame: 0 hour
|
The investigators will measure the viability of Parathyroid cells at 0 hour at the BAVU solution
|
0 hour
|
|
Cell viability of Parathyroid cells
Time Frame: 6 hours
|
The investigators will measure the viability of Parathyroid cells at 6 hours at the BAVU solution
|
6 hours
|
|
Cell viability of Parathyroid cells
Time Frame: 12 hours
|
The investigators will measure the viability of Parathyroid cells at 12 hours at the BAVU solution
|
12 hours
|
|
Cell viability of Parathyroid cells
Time Frame: 18 hours
|
The investigators will measure the viability of Parathyroid cells at 18 hours at the BAVU solution
|
18 hours
|
|
Cell viability of Parathyroid cells
Time Frame: 24 hours
|
The investigators will measure the viability of Parathyroid cells at 24 hours at the BAVU solution
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (ANTICIPATED)
November 1, 2016
Study Completion (ANTICIPATED)
December 1, 2016
Study Registration Dates
First Submitted
November 24, 2016
First Submitted That Met QC Criteria
November 29, 2016
First Posted (ESTIMATE)
November 30, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
November 30, 2016
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BAVU Solusyon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.