Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Parathyroid Allotransplant

    Procedure/Surgery

    Patients that meet inclusion criteria and are enrolled in the trial will undergo parathyroid allotransplantation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Parathyroid transplant function

Detectable PTH

Time frame
8 weeks post-operatively
2

Calcium supplementation

Amount and type of calcium supplements needed post-operatively

Time frame
6 months post-operatively

Secondary outcomes

1

Serum calcium level

Time frame
6 months post-operatively
2

Immunosuppression-related adverse events

Infections or other adverse events

Time frame
12 months post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: