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Parathyroid Allo-transplantation With a New Technique

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ClinicalTrials.gov Identifier: NCT02134483
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Erhan Aysan, SB Istanbul Education and Research Hospital

Tracking Information
First Submitted Date  ICMJE May 1, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE September 1, 2013
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
to mesure patient's blood calcium [ Time Frame: up to three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
to mesure patient's parathormon levels [ Time Frame: up to three months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2014)
to control patient's need for calcium containing drugs [ Time Frame: up to three months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Parathyroid Allo-transplantation With a New Technique
Official Title  ICMJE Parathyroid Allo-transplantation With a New Technique
Brief Summary Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.
Detailed Description

Hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . Direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. Temporary hypoparathyroidism (<6 months) develops at 10% of cases after thyroid surgery and nearly half of them develops permanent hypoparathyroidism (>6 months) (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism.

As a current standard treatment, oral or intravenous calcium preparations and active vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no beneficial effect on metabolic problems due to PH.

For these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative. Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. Various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. Despite these treatment options, convincing results have not yet been achieved . In literature, PA-t cases are often presented as case reports, only a few clinical series are available .

In this study, we aimed to present the results of our new PA-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parathyroid Allo-transplantation
Intervention  ICMJE Biological: Parathyroid allo-transplantation
parathyroid allotransplantation with a new tecnique without immunosuppression
Study Arms  ICMJE Experimental: Parathyroid allo-transplantation
patients who have permanent hypoparatyroidism
Intervention: Biological: Parathyroid allo-transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
10
Actual Study Completion Date  ICMJE December 1, 2015
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who have permanent hypocalcemia
  • Patients who accept to participate to study

Exclusion Criteria:

-Patients who don't accept to participate to study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134483
Other Study ID Numbers  ICMJE 1234567
79797979 ( Registry Identifier: Bezmialem Vakif University )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erhan Aysan, SB Istanbul Education and Research Hospital
Study Sponsor  ICMJE Erhan Aysan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: erhan aysan Bezmialem Vakif University
PRS Account SB Istanbul Education and Research Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP