Parathyroid Allotransplant for Treatment of Hypoparathyroidism: PATTH
Peter Stock
Summary
This study is being done to see if transplanting parathyroid tissue into the forearm will help hypo-parathyroid patients achieve parathyroid hormone (PTH) levels that would help normalize their serum calcium and phosphorus levels. The parathyroid tissue used in this study will come from cadaveric tissues that were donated at the time of the death of the donor(s).
Description
The company that makes the parathyroid hormone NATPARA will no longer be making the product by the end of 2024 which is one of the reasons the investigators are doing this study: to see if parathyroid transplantation is another way to treat hypoparathyroidism. This procedure is investigational and one of the first times the procedure is being done in humans. It is not approved by the FDA.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Only subjects who meet all of the following criteria are eligible for enrollment. 1. Subjects age 18 or older. 2. Subjects who are able to provide written informed consent and to comply with study procedures. 3. Clinical history and laboratory data compatible with HypoPT as defined by hypocalcemia and documented PTH levels either inappropriately normal or below the normal range on two occasions greater than 2 weeks apart and 12 months after surgery, requiring treatment with activated vitamin D (≥0.5 mcg calcitrol) and oral calcium (≥800mg) daily, or currently on PTH (1-84),…
Interventions
- BiologicalParathyroid Allotransplant
Parathyroid Allotransplant
Location
- University of California, San FranciscoSan Francisco, California