Parathyroid Allotransplant for Treatment of Hypoparathyroidism: PATTH
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Levels of intact PTH
Study Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Parathyroid Allotransplant
Parathyroid Allotransplant to treat hypoparathyroidism
Intervention: Parathyroid Allotransplant (Biological)
Outcomes
Primary Outcomes
Levels of intact PTH
Time Frame: From baseline to week 52 (year 1)
The primary efficacy endpoint is attainment of levels of intact PTH that are in the normal target range and at least a doubling of the baseline intact PTH level prior to transplantation
Incidence of Adverse Events
Time Frame: From baseline to Year 1
The primary safety endpoint is the incidence of adverse events related to the transplant procedure or immunosuppression, incidence of post- transplant infections and malignancies, incidence of de novo sensitization
Secondary Outcomes
- Dose of oral calcium supplements and calcitrol(From baseline to week 52 (year 1))
- Dose of subcutaneous parathyroid hormone (PTH) replacement therapy(From baseline to week 52 (year 1))
- PTH replacement therapy(From baseline to week 52 (year 1))
Investigators
Peter Stock
Professor of Surgery (MD, PhD)
University of California, San Francisco