About this trial
Options for treatment of severe, refractory hypocalcemia are limited for the thousands of patients in the United States who suffer from hypoparathyroidism. Parathyroid allotransplantation is an emerging treatment that provides hope for these individuals. Currently, this therapy has only been successfully provided by a few centers in the world. In the UAB PATH trial, we propose to become one of the few centers worldwide to successfully achieve parathyroid allotransplantation in transplant-naïve patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individual diagnosed with hypocalcemia secondary to
Prior anterior cervical neck surgery resulting in hypoparathyroidism
Congenital absence or malformation of parathyroid glands during development
Presence of hypoparathyroidism for at least one year
Disqualifiers
Any active malignancy, except non-melanoma skin cancer
Dependence on nursing home or other long-term care provider
History of ischemic cardiomyopathy with ejection fraction <20%, uncontrolled diabetes mellitus (Hgb A1c >10), thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
History of significant psychiatric illness
Trial design
Single group
Treatments tested in this trial
Parathyroid Allotransplant
Procedure/SurgeryPatients that meet inclusion criteria and are enrolled in the trial will undergo parathyroid allotransplantation
Treatment groups
Trial outcomes
Primary outcomes
Parathyroid transplant function
Detectable PTH
Calcium supplementation
Amount and type of calcium supplements needed post-operatively
Secondary outcomes
Serum calcium level
Immunosuppression-related adverse events
Infections or other adverse events
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: