Working… Menu

Parathyroid Allo-transplantation With a New Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134483
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 23, 2017
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02134483

Layout table for location information
Bezmialem Vakif University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Erhan Aysan
Layout table for investigator information
Principal Investigator: erhan aysan Bezmialem Vakif University
Study Data/Documents: Article  This link exits the site

Layout table for additonal information
Responsible Party: Erhan Aysan, Bezmialem Vakif University, SB Istanbul Education and Research Hospital Identifier: NCT02134483    
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:
Permanent hypocalcemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs