Parathyroid Allotransplant for Treatment of Hypoparathyroidism
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter Stock
About this trial
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).
Eligibility criteria
Qualifiers
Subjects age 18 or older.
Subjects who are able to provide written informed consent and to comply with study procedures.
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), PTH (1-34), palopegteriparatide or other recombinant parathyroid hormone replacement injections with ongoing symptomatology due to hypocalcemia and variable degree of biochemical control.
No history of immunodeficiency (e.g., opportunistic infections) that could be exacerbated by immunosuppression.
Disqualifiers
Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
Intolerance to any drug that will be used as part of the IS regimen.
Poorly controlled diabetes with an A1C of >8%.
Blood Pressure (BP): systolic blood pressure (SBP) > 140mmHg or DBP >90 mmHg despite treatment with antihypertensive agents. If the BP is greater than 140/90 chart review and discussion with the patient will be done to establish that BP is in good control.
Trial design
Treatments tested in this trial
- Parathyroid Allotransplant
Treatment groups
3 Participants
are divided into 1 treatment groupSponsors and collaborators
Peter Stock
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov