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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Parathyroid Allotransplant
Biological/VaccineParathyroid Allotransplant
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Parathyroid AllotransplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Levels of intact PTH
The primary efficacy endpoint is attainment of levels of intact PTH levels that are in the normal range and at least double the baseline intact PTH level at one year following the PTG transplant from a single donor.
Time frame
From baseline to week 52 (year 1)2
Incidence of Serious Adverse Events
The primary safety endpoints are the incidence of serious adverse events related to the transplant procedure or immunosuppression, incidence of post- transplant infections and malignancies, incidence of de novo sensitization.
Time frame
From baseline to Year 1Secondary outcomes
1
Dose of oral calcium supplements and calcitrol
in patients on conventional Ca and calcitriol supplementation, a 50% reduction in the pre-transplant oral dose of calcium supplements and calcitrol with maintenance of stable serum calcium in the normal;
Time frame
From baseline to week 52 (year 1)2
Dose of subcutaneous parathyroid hormone (PTH) replacement therapy
for patients on subcutaneous PTH replacement therapy, a 50% reduction in the dose of PTH replacement therapy with maintenance of serum calcium in the normal target range.
Time frame
From baseline to week 52 (year 1)3
PTH replacement therapy
Discontinuation of PTH replacement therapy while maintaining serum calcium in the normal target range while taking 1000 mg or less of elemental calcium in the form of calcium supplements.
Time frame
From baseline to week 52 (year 1)Other outcomes
1
Quality of Life measurement
An exploratory endpoint is the improvement in one or more quality of life measurements comparing baseline with one-year post-transplant using the Medical Outcomes Study Short Form 36 (SF36) survey and the Hypoparathyroidism Experience Scale (HPES).
Time frame
From baseline to Year 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peter Stock
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov