Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism

NCT05114980 | Not Yet Recruiting

• 1 other identifier: IRB-3000008285
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (2)

• Parathyroid transplant function

  Detectable PTH

  8 weeks post-operatively

• Calcium supplementation

  Amount and type of calcium supplements needed post-operatively

  6 months post-operatively

Secondary Outcomes (2)

• Serum calcium level

  6 months post-operatively

• Immunosuppression-related adverse events

  12 months post-operatively

Interventions

Parathyroid Allotransplant PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual diagnosed with hypocalcemia secondary to
• Hypoparathyroidism:
• 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
• Failure of medical treatment for hypocalcemia, including need for IV calcium, with negative impact on quality of life and daily function
• Age 18-80 years
• Lives in the greater Birmingham region for the duration of the trial
• Fluent in the English Language
• Willing to comply with screening, protocol and all required procedures

You may not qualify if:

• 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
• Severe osteoporosis
• Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
• Documented history of gross non-adherence to medical therapies
• Significant functional/cognitive impairment without reliable caregiver
• Presence of active documented systemic infection or recent systemic infection within the past 3 months
• Seropositivity for HIV, HBV core antibody or antigen, HCV, HTLV-1
• Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
• Chemical and/or alcohol dependency or abuse
• Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders)
• Resources deemed inadequate to support necessary post-transplant care

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Brenessa Lindeman, MD, MEHP

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenessa Lindeman, MD

CONTACT

205-975-5000; blindeman@uabmc.edu

Brenessa Lindeman, MD, MEHP

CONTACT

205-975-5000; blindeman@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)