Transplanting parathyroid glands to treat severe hypoparathyroidism
Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism
NA · University of Alabama at Birmingham · NCT05114980
This study is testing if transplanting parathyroid glands can help people with severe hypoparathyroidism who haven't found relief from standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05114980 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of parathyroid allotransplantation as a treatment for patients suffering from medically refractory hypoparathyroidism. The study aims to provide a solution for individuals who have not responded to conventional treatments, such as calcium and vitamin D supplementation. Participants will undergo a surgical procedure to transplant parathyroid tissue, with the goal of restoring normal parathyroid hormone levels and alleviating symptoms associated with hypocalcemia. The trial is being conducted at the University of Alabama at Birmingham, which seeks to become one of the few centers globally to offer this innovative treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who have been diagnosed with hypoparathyroidism for at least one year and have not responded to medical treatments.
Not a fit: Patients with active malignancies, severe heart conditions, or those requiring long-term care may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with severe hypoparathyroidism by reducing their dependence on medications and alleviating debilitating symptoms.
How similar studies have performed: While parathyroid allotransplantation is an emerging treatment, few centers have successfully implemented it, indicating that this approach is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Brenessa Lindeman, MD, MEHP — University of Alabama at Birmingham
- Study coordinator: Brenessa Lindeman, MD
- Email: blindeman@uabmc.edu
- Phone: 205-975-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoparathyroidism