Parathyroid AllotransplantationNCT02978287
New Transporting Solution in Parathyroid Allotransplantation
A study testing BAVU Solution in people with Parathyroid Allotransplantation, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. 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?
- BAVU Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2016to Dec 2016
- 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 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem University
Istanbul, 34093
Erhan Aysan, Prof M.D., +905322034879, erhanaysan@hotmail.com
Ufuk Oguz Idiz, M.D., +905062044714, oguzidiz@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parathyroid Allotransplantation
- Being tested
- BAVU Solution
- Keywords
- Calcium sensing receptor, Parathyroid cell viability, Parathyroid allotransplantation, Transporting solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAVU SolutionDrug
Tissue preservation solution for transplantation
| Study group | Role | What they receive |
|---|---|---|
| BAVU Solution 0. hour (control) | No intervention | Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour |
| BAVU Solution 6. hour | Experimental | Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour Receives: Drug: BAVU Solution |
| BAVU Solution 12. hour | Experimental | Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour Receives: Drug: BAVU Solution |
| BAVU Solution 18. hour | Experimental | Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour Receives: Drug: BAVU Solution |
| BAVU Solution 24. hour | Experimental | Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour Receives: Drug: BAVU Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell viability of Parathyroid cells
The investigators will measure the viability of Parathyroid cells at 0 hour at the BAVU solution
Measured: 0 hour
Cell viability of Parathyroid cells
The investigators will measure the viability of Parathyroid cells at 6 hours at the BAVU solution
Measured: 6 hours
Cell viability of Parathyroid cells
The investigators will measure the viability of Parathyroid cells at 12 hours at the BAVU solution
Measured: 12 hours
Cell viability of Parathyroid cells
The investigators will measure the viability of Parathyroid cells at 18 hours at the BAVU solution
Measured: 18 hours
Cell viability of Parathyroid cells
The investigators will measure the viability of Parathyroid cells at 24 hours at the BAVU solution
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978287
- Sponsor's protocol ID
- BAVU Solusyon
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 21566713Hendy 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.
PubMed 20374733Voigt 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 24311404Nawrot 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.
PubMed 17414706
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cold Ischemia Time With a New Transporting Solution to Parathyroid Cell Viability and Calcium Sensing Receptor in Parathyroid Allotransplantation
- ClinicalTrials.gov ID
- NCT02978287
- Acronym / sponsor ID
- BAVU Solusyon
- Conditions
- Parathyroid Allotransplantation
- Keywords
- Calcium sensing receptor, Parathyroid cell viability, Parathyroid allotransplantation, Transporting solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BAVU Solution 0. hour (control) | No intervention | –Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour |
| BAVU Solution 6. hour | Experimental | Drug: BAVU SolutionViability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour |
| BAVU Solution 12. hour | Experimental | Drug: BAVU SolutionViability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour |
| BAVU Solution 18. hour | Experimental | Drug: BAVU SolutionViability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour |
| BAVU Solution 24. hour | Experimental | Drug: BAVU SolutionViability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour |
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 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)
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 |
|---|---|---|
| BAVU SolutionTissue preservation solution for transplantation | Drug | BAVU Solution 12. hour, BAVU Solution 18. hour, BAVU Solution 24. hour, BAVU Solution 6. hour |
Primary outcome
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Results publication: 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.
- Results publication: PubMed 20374733Hendy 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.
- Results publication: 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.
- Results publication: PubMed 17414706Nawrot 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.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAVU Solution in people with Parathyroid Allotransplantation, run by Sisli Hamidiye Etfal Training 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 30 Nov 2016. 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. (+905322034879, 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 (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 NCT02978287, 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 30 Nov 2016.