Phase 12 Study of Parathyroid Tissue Transplant to Treat Hypoparathyroidism Using Donor Tissue

What this Trial Is About

Researchers are evaluating whether transplanting parathyroid tissue into the forearm can help people with hypoparathyroidism reach parathyroid hormone PTH levels that normalize calcium and phosphorus in the blood. This study is motivated by the upcoming discontinuation of the parathyroid hormone drug NATPARA by its manufacturer. This investigational procedure uses donated parathyroid tissue from deceased donors and is one of the first times this approach is being tested in humans, without FDA approval yet. Participants will receive a parathyroid allotransplant, where donated parathyroid tissue is transplanted to treat hypoparathyroidism. The study is conducted in phases 1 and 2 to assess this new biological intervention. The plan includes monitoring the transplants ability to restore PTH levels, with no placebo or comparator group mentioned. During the study, participants will be followed for one year to measure intact PTH levels and watch for serious adverse events. Researchers will also track the doses of oral calcium, activated vitamin D, and parathyroid hormone replacement therapy required. The study involves regular clinical and laboratory evaluations to assess safety, hormone control, and supplement needs, ensuring participant health and treatment monitoring throughout the year.

Parathyroid Allotransplant for Treatment of Hypoparathyroidism