Parathyroid AllotransplantationNCT03051308
University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation
A study testing NPT and UW Solution in people with Parathyroid Allotransplantation, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parathyroid Allotransplantation
- What is being tested?
- NPT and UW Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have parathyroid hyperplasia due to chronic renal failure.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University Hospital
Istanbul, 34093
Erhan Aysan, Prof. M.D., +902124531700 ext. 2465, erhanaysan@hotmail.com
Beyza Goncu, Msc, +902124531700 ext. 1465, bsgoncu@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parathyroid Allotransplantation
- Being tested
- NPT and UW Solution
- Keywords
- Parathyroid cell viability, Ischemia, Parathyroid allotransplantation, Vitamin D Receptor, Calcium Sensing Receptor
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT and UW SolutionCombination product
Tissue preservation solutions for transplantation
| Study group | Role | What they receive |
|---|---|---|
| First Application in Hour 0 | Experimental | 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 Receives: Combination Product: NPT and UW Solution |
| First Application in Hour 6 | Experimental | 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 Receives: Combination Product: NPT and UW Solution |
| First Application in Hour 12 | Experimental | 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 Receives: Combination Product: NPT and UW Solution |
| First Application in Hour 18 | Experimental | 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 Receives: Combination Product: NPT and UW Solution |
| First Application in Hour 24 | Experimental | 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 Receives: Combination Product: NPT and UW Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hour
Secondary outcomes (1)
Parathormone Release of Parathyroid Cells
The investigators will measure the parathormone level from cultured parathyroid cells
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parathyroid AllotransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
- Investigators
- Erhan Aysan, Prof. M.D., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051308
- Sponsor's protocol ID
- BAVUvsUW
- Status last verified
- Feb 2017
- First submitted
- 29 Jan 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 3282347Southard 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.
PubMed 1689516Guibert 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.
PubMed 21566713Voigt 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.
PubMed 24311404
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia
- ClinicalTrials.gov ID
- NCT03051308
- Acronym / sponsor ID
- BAVUvsUW
- Conditions
- Parathyroid Allotransplantation
- Keywords
- Parathyroid cell viability, Ischemia, Parathyroid allotransplantation, Vitamin D Receptor, Calcium Sensing Receptor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| First Application in Hour 0 | Experimental | Combination Product: NPT and UW SolutionViability, 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 |
| First Application in Hour 6 | Experimental | Combination Product: NPT and UW SolutionViability, 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 |
| First Application in Hour 12 | Experimental | Combination Product: NPT and UW SolutionViability, 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 |
| First Application in Hour 18 | Experimental | Combination Product: NPT and UW SolutionViability, 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 |
| First Application in Hour 24 | Experimental | Combination Product: NPT and UW SolutionViability, 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have parathyroid hyperplasia due to chronic renal failure.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPT and UW SolutionTissue preservation solutions for transplantation | Combination product | First Application in Hour 0, First Application in Hour 12, First Application in Hour 18, First Application in Hour 24, First Application in Hour 6 |
Primary outcome
Cell viability of Parathyroid cells after isolation process
Time frame: 0 hour
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.
Cell viability of Parathyroid cells after 6 hour of cold ischemia
Time frame: 6 hour
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.
Cell viability of Parathyroid cells after 12 hour of cold ischemia
Time frame: 12 hour
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.
Cell viability of Parathyroid cells after 18 hour of cold ischemia
Time frame: 18 hour
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.
Cell viability of Parathyroid cells after 24 hour of cold ischemia
Time frame: 24 hour
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.
1 secondary outcome
Parathormone Release of Parathyroid Cells
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Background: PubMed 3282347Belzer 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.
- Background: PubMed 1689516Southard 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.
- Background: PubMed 21566713Guibert 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.
- Background: PubMed 24311404Voigt 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Aysan, Prof. M.D. study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPT and UW Solution in people with Parathyroid Allotransplantation, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erhan Aysan, Prof. M.D. (+902124531700 ext. 2465, erhanaysan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell viability of Parathyroid cells after isolation process (time frame: 0 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03051308, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.