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
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
Treatments tested in this trial
- Donor Parathyroid
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Karen Devon
Lead sponsor
University Health Network, Toronto
Sponsor institution
University Health Network, Toronto
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov