NOT_YET_RECRUITING

Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism

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Conditions

Hypoparathyroidism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism

Quick Facts

Study Start:2027-07
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:NOT_YET_RECRUITING

Study ID

NCT05114980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Study Contact

Brenessa Lindeman, MD
CONTACT
205-975-5000
blindeman@uabmc.edu
Brenessa Lindeman, MD, MEHP
CONTACT
205-975-5000
blindeman@uabmc.edu

Principal Investigator

Brenessa Lindeman, MD, MEHP
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Brenessa Lindeman, MD, MEHP, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2027-07
Study Completion Date2030-01

Study Record Updates

Study Start Date2027-07
Study Completion Date2030-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hypoparathyroidism