Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Oct 29, 2021

Keywords

ClinConnect Summary

The UAB PATH trial is studying a new treatment called parathyroid allotransplantation for patients with severe hypoparathyroidism, a condition that causes low calcium levels and can be hard to manage with current medications. This trial aims to help those who have not found relief from their symptoms and have had low calcium levels for at least a year, especially if they require intravenous (IV) calcium. Eligible participants are adults aged 18 to 80 who live in the greater Birmingham area, have a diagnosis of hypoparathyroidism due to surgery or developmental issues, and are fluent in English.

If you join the trial, you can expect to receive specialized medical care and monitoring throughout the process. However, there are specific criteria to ensure safety, such as not having certain serious health conditions or active cancers. This trial offers a unique opportunity as it is one of the few centers in the world conducting this type of transplant, potentially providing a new hope for better management of hypoparathyroidism.

Gender

ALL

Eligibility criteria

• 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