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
|Condition or disease||Intervention/treatment||Phase|
|Parathyroid Allo-transplantation||Biological: Parathyroid allo-transplantation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Parathyroid Allo-transplantation With a New Technique|
|Actual Study Start Date :||September 1, 2013|
|Actual Primary Completion Date :||May 1, 2015|
|Actual Study Completion Date :||December 1, 2015|
Experimental: Parathyroid allo-transplantation
patients who have permanent hypoparatyroidism
Biological: Parathyroid allo-transplantation
parathyroid allotransplantation with a new tecnique without immunosuppression
- to mesure patient's blood calcium [ Time Frame: up to three months ]
- to mesure patient's parathormon levels [ Time Frame: up to three months ]
- to control patient's need for calcium containing drugs [ Time Frame: up to three months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134483
|Bezmialem Vakif University|
|Istanbul, Turkey, 34093|
|Principal Investigator:||erhan aysan||Bezmialem Vakif University|