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New treatment option for Hypoparathyroidism Postprocedural
Official title Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
ClinicalTrials.gov ID: NCT06499246
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Prior total thyroidectomy
- Symptomatic hypocalcemia (numbness, tingling, or other neurologic symptoms) requiring daily high dose calcium (greater than 2000 mg per day) and...
- 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...
You likely can't join 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...
See the full eligibility 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...
- 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)
- \<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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.