NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University of Alabama at Birmingham
Conditions: Hypoparathyroidism
Interventions: Parathyroid Allotransplant
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria:
* Individual diagnosed with hypocalcemia secondary to
1. Hypoparathyroidism:
1. Prior anterior cervical neck surgery resulting in hypoparathyroidism
2. Congenital absence or malformation of parathyroid glands during development
2. Presence of hypoparathyroidism for at least one year
3. Failure of medical treatment for hypocalcemia, including need for IV calcium, with negative impact on quality of life and daily function
4. Age 18-80 years
5. Lives in the greater Birmingham region for the duration of the trial
6. Fluent in the English Language
7. Willing to comply with screening, protocol and all required procedures
Exclusion Criteria:
1. Any active malignancy, except non-melanoma skin cancer
2. Dependence on nursing home or other long-term care provider
3. 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
4. History of significant psychiatric illness
5. Severe osteoporosis
6. Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
7. Documented history of gross non-adherence to medical therapies
8. Significant functional/cognitive impairment without reliable caregiver
9. Presence of active documented systemic infection or recent systemic infection within the past 3 months
10. Seropositivity for HIV, HBV core antibody or antigen, HCV, HTLV-1
11. Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
12. Chemical and/or alcohol dependency or abuse
13. Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders)
14. Resources deemed inadequate to support necessary post-transplant care- Birmingham, Alabama, United States