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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

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.

Condition or disease Intervention/treatment Phase
Parathyroid Allo-transplantation Biological: Parathyroid allo-transplantation Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parathyroid allo-transplantation
patients who have permanent hypoparatyroidism
Biological: Parathyroid allo-transplantation
parathyroid allotransplantation with a new tecnique without immunosuppression




Primary Outcome Measures :
  1. to mesure patient's blood calcium [ Time Frame: up to three months ]

Secondary Outcome Measures :
  1. to mesure patient's parathormon levels [ Time Frame: up to three months ]

Other Outcome Measures:
  1. to control patient's need for calcium containing drugs [ Time Frame: up to three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
Turkey
Bezmialem Vakif University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Erhan Aysan
Investigators
Principal Investigator: erhan aysan Bezmialem Vakif University

Study Data/Documents: Article  This link exits the ClinicalTrials.gov site

Responsible Party: Erhan Aysan, Bezmialem Vakif University, SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02134483     History of Changes
Other Study ID Numbers: 1234567
79797979 ( Registry Identifier: Bezmialem Vakif University )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Erhan Aysan, SB Istanbul Education and Research Hospital:
Parathyroid
Permanent hypocalcemia
Transplantation