Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
Recruiting now · Not applicable
Conditions studied: Hypoparathyroidism Postprocedural
In brief
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.
Key facts
- Study ID
- NCT06499246
- Run by
- Karen Devon
- People needed
- 5
- Starts
- 2024-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2024-07-12
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- <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.
Where it is running
- University Health Network — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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