Status:
RECRUITING
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
Lead Sponsor:
Karen Devon
Collaborating Sponsors:
University Health Network, Toronto
University of Toronto
Conditions:
Hypoparathyroidism Postprocedural
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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...
Detailed Description
A protocol for deceased donor parathyroid transplantation was developed with the University Health Network Ajmera Transplant Centre in Toronto, relevant stakeholders, and presented to the innovation c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- \<18 years old male or female
- Current pregnancy
- Advanced stage 3-4 thyroid cancer
- Contraindication to surgery or immunosuppression
- Malignancy with contraindication to transplant:
- Certain active malignancies are not a contraindication to transplant such as prostate cancer or lymphoproliferative disease in remission, and locoregional skin malignancies such as melanoma will be transplant candidates (outlined in Preexisting melanoma and hematological malignancies, prognosis, and timing to solid organ transplantation: A consensus expert opinion statement by Al-Adra et al respectively).
- Remote malignancies with successful treatment will not preclude patients from inclusion in the study. Dependent upon the malignancy risk level a minimal time from treatment will be required as established by the consensus recommendations outlined in Pretransplant solid organ malignancy and organ transplant candidacy: A consensus expert opinion statement by Al-Adra et al.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06499246
Start Date
July 1 2024
End Date
July 1 2028
Last Update
July 12 2024
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5S1B2