Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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)

• Patient meets current standards for receiving an organ transplant (e.g. no active infection, no malignancy, no contraindications to immunosuppression or surgery)

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Karen Devon, MD, MSc, FRCSC, FACS
karen.devon@wchospital.ca
416-323-6400
Backup
Esther Lee, BScN
esther.lee@uhn.ca
416-340-4800
Time Frame
Start Date: 2024-07
Estimated Completion Date: 2028-07
Participants
Target number of participants: 5
Treatments
Experimental: Parathyroid Transplant
Patients with permanent refractory hypoparathyroidism after total thyroidectomy will be entered in this study to undergo parathyroid transplantation from a neurologically deceased donor. Inclusion criteria are patients who have had a prior total thyroidectomy with both biochemical hypoparathyroidism and symptomatic hypocalcemia (numbness, tingling, or other neurologic symptoms) requiring daily high dose calcium (greater than 2000 mg per day), vitamin D (greater than 2 mcg of calcitriol per day) supplementation and/or intermittent IV calcium infusion. Patients for inclusion must have failed this medical management after at least 1 year of treatment and meet standard criteria for receiving organ transplant.
Related Therapeutic Areas
Sponsors
Leads: Karen Devon
Collaborators: University of Toronto, University Health Network, Toronto

This content was sourced from clinicaltrials.gov