New Transporting Solution in Parathyroid Allotransplantation

NCT ID: NCT02978287

Last Updated: 2016-11-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parathyroid Allotransplantation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Calcium sensing receptor Parathyroid cell viability Parathyroid allotransplantation Transporting solution

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BAVU Solution 0. hour (control)

Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 0. hour

Group Type NO_INTERVENTION

No interventions assigned to this group

BAVU Solution 6. hour

Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 6. hour

Group Type EXPERIMENTAL

BAVU Solution

Intervention Type DRUG

Tissue preservation solution for transplantation

BAVU Solution 12. hour

Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 12. hour

Group Type EXPERIMENTAL

BAVU Solution

Intervention Type DRUG

Tissue preservation solution for transplantation

BAVU Solution 18. hour

Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 18. hour

Group Type EXPERIMENTAL

BAVU Solution

Intervention Type DRUG

Tissue preservation solution for transplantation

BAVU Solution 24. hour

Viability, Calcium sensing receptor and parathormone levels of Parathyroid cells at 24. hour

Group Type EXPERIMENTAL

BAVU Solution

Intervention Type DRUG

Tissue preservation solution for transplantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAVU Solution

Tissue preservation solution for transplantation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ufuk Oguz Idiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Erhan Aysan, Prof. M.D.

Role: CONTACT

Phone: +905322034879

Email: [email protected]

Ufuk Oguz Idiz, M.D.

Role: CONTACT

Phone: +905062044714

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erhan Aysan, Prof M.D.

Role: primary

Ufuk Oguz Idiz, M.D.

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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 RESULT
PMID: 21566713 (View on PubMed)

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.

Reference Type RESULT
PMID: 20374733 (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 RESULT
PMID: 24311404 (View on PubMed)

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.

Reference Type RESULT
PMID: 17414706 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BAVU Solusyon

Identifier Type: -

Identifier Source: org_study_id