Transplanting parathyroid glands to treat severe hypoparathyroidism
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
This study is testing if transplanting parathyroid glands from donors can help people with severe hypoparathyroidism who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06499246 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of parathyroid allotransplantation from deceased donors in patients suffering from severe refractory hypoparathyroidism following total thyroidectomy. Participants will undergo a comprehensive assessment by a multidisciplinary team before receiving the transplant. The study aims to evaluate outcomes in patients who have not responded to conventional treatments for at least one year. There is no control group, and the focus is on a cohort of patients with significant symptoms requiring high doses of calcium and vitamin D supplementation.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone total thyroidectomy and have persistent symptomatic hypoparathyroidism despite medical management.
Not a fit: Patients under 18 years old, those with advanced thyroid cancer, or individuals with contraindications to surgery or immunosuppression will not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve the quality of life for patients with severe hypoparathyroidism by alleviating debilitating symptoms.
How similar studies have performed: While this approach is novel, the first successful case of parathyroid allotransplantation has been reported, indicating potential for success in similar cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * \<18 years old male or female * Current pregnancy * Advanced stage 3-4 thyroid cancer * Contraindication to surgery or immunosuppression * Malignancy with contraindication to transplant: 1. 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). 2. 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 this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Karen Devon, MD, MSc, FRCSC, FACS — University Health Network, Toronto
- Study coordinator: Karen Devon, MD, MSc, FRCSC, FACS
- Email: karen.devon@wchospital.ca
- Phone: 416-323-6400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.