NCT02978287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

November 24, 2016

Last Update Submit

November 29, 2016

Conditions

Parathyroid Allotransplantation

Keywords

Calcium sensing receptorParathyroid cell viabilityParathyroid allotransplantationTransporting solution

Outcome Measures

Primary Outcomes (5)

  • Cell viability of Parathyroid cells

    The investigators will measure the viability of Parathyroid cells at 0 hour at the BAVU solution

    0 hour

  • Cell viability of Parathyroid cells

    The investigators will measure the viability of Parathyroid cells at 6 hours at the BAVU solution

    6 hours

  • Cell viability of Parathyroid cells

    The investigators will measure the viability of Parathyroid cells at 12 hours at the BAVU solution

    12 hours

  • Cell viability of Parathyroid cells

    The investigators will measure the viability of Parathyroid cells at 18 hours at the BAVU solution

    18 hours

  • Cell viability of Parathyroid cells

    The investigators will measure the viability of Parathyroid cells at 24 hours at the BAVU solution

    24 hours

Study Arms (5)

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

Drug: BAVU Solution

BAVU Solution 12. hour

EXPERIMENTAL

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

Drug: BAVU Solution

BAVU Solution 18. hour

EXPERIMENTAL

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

Drug: BAVU Solution

BAVU Solution 24. hour

EXPERIMENTAL

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

Drug: BAVU Solution

Interventions

BAVU SolutionDRUG

Tissue preservation solution for transplantation

BAVU Solution 12. hourBAVU Solution 18. hourBAVU Solution 24. hourBAVU Solution 6. hour

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have parathyroid hyperplasia due to chronic renal failure

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21566713RESULT

  • 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.

    PMID: 20374733RESULT

  • 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.

    PMID: 24311404RESULT

  • 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.

    PMID: 17414706RESULT

Central Study Contacts

Erhan Aysan, Prof. M.D.

CONTACT

+905322034879erhanaysan@hotmail.com

Ufuk Oguz Idiz, M.D.

CONTACT

+905062044714oguzidiz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 30, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)