Parathyroid Allo-transplantation With a New Technique

NCT ID: NCT02134483

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2015-12-01

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

Conditions

Parathyroid Allo-transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parathyroid allo-transplantation

patients who have permanent hypoparatyroidism

Group Type: EXPERIMENTAL

Parathyroid allo-transplantation

Intervention Type: BIOLOGICAL

parathyroid allotransplantation with a new tecnique without immunosuppression

Interventions

Parathyroid allo-transplantation

parathyroid allotransplantation with a new tecnique without immunosuppression

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erhan Aysan

OTHER

Sponsor Role: lead

Responsible Party

Erhan Aysan

Bezmialem Vakif University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

erhan aysan

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: Article

View Document

Other Identifiers

79797979

Identifier Type: REGISTRY

Identifier Source: secondary_id

1234567

Identifier Type: -

Identifier Source: org_study_id