Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism

ConditionHypoparathyroidism Postprocedural

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorKaren Devon

About this trial

Hypoparathyroidism following thyroid surgery presents significant challenges, often leading to debilitating symptoms and reduced quality of life despite conventional treatment. Having now reported the first successful case of a deceased donor fresh tissue parathyroid allotransplant with immunosuppression in a transplant-naive recipient, the purpose of this study is to further assess the safety and efficacy of this procedure in patients with severe intractable post-surgical hypoparathyroidism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prior total thyroidectomy

Symptomatic hypocalcemia (numbness, tingling, or other neurologic symptoms) requiring daily high dose calcium (greater than 2000 mg per day) and vitamin D (greater than 2 mcg of calcitriol per day) supplementation and/or intermittent IV calcium infusion.

Biochemical blood test consistent with hypoparathyroidism

Failed medical management (>1 year of post-thyroidectomy hypoparathyroidism treated medically with persistent biochemical disease and symptoms)

Disqualifiers

<18 years old male or female

Current pregnancy

Advanced stage 3-4 thyroid cancer

Contraindication to surgery or immunosuppression

Trial design

Design model

Single group

Treatments tested in this trial

Donor Parathyroid
Procedure/Surgery
Once a potential donor becomes available, the transplant team will assess if the donor is a match for our study participant using standardized transplantation protocols that include serology blood tests completed in the pre-operative setting. If the donor is a match, the procurement team will procure all parathyroid tissue using standard surgical techniques. The specimen will be kept in organ preservation solution for transport and transported to the operating room. The recipient (study participant) will be admitted to the hospital under and taken to the operating room for the surgical procedure. Once the procurement team arrives with the parathyroid tissue the procedure will be performed under local anesthesia using a well-established technique, for parathyroid auto transplant, of implanting parathyroid tissue in the non-dominant brachioradialis muscle. Immunosuppression medication protocols will be initiated.

Treatment groups

5 Participants

are divided into 1 treatment group

Group A: Parathyroid TransplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maintain calcium levels without standard calcium replacement treatment.

Patients will demonstrate improvement in hypocalcemia symptoms, biochemical calcium profile, and parathyroid hormone levels as well as decrease frequency of emergency visits for intravenous calcium. Specifically at each assessment patients will be questioned regarding numbness and tingling and will be examined for presence of Chvostek's and Trousseau's sign. Additionally, to assess overall impact of symptoms in relation to quality of life. A hypoparathyroidism quality-of-life questionnaire will be filled out by the patient pre-operatively and at 12 months post-operatively. This questionnaire was formulated and has been used for research purposes by the HypoParaUK group. Biochemical calcium profile (serum total calcium, albumin, ionized calcium, parathyroid hormone level, vitamin D level, phosphate) using blood tests done on post-operative day 1, 3, 5, 7, and subsequently 2 weeks, 3 weeks, 4 weeks post-operatively, and afterwards monthly for a total of 12 months post-operatively.

Time frame

Pre-operatively and then at 4 weeks, 3 months and 12 months post-operatively

Secondary outcomes

Rate of surgical complications

Whether parathyroid allotransplant from neurologically deceased donors amongst patients with permanent refractory hypoparathyroidism has minimal surgical and medical complications and the need for medications.

Time frame

4 weeks, 3 months and 12 months post-operatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karen Devon

Lead sponsor

University Health Network, Toronto

Sponsor institution

University Health Network, Toronto

Collaborator

University of Toronto