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Procedure

Parathyroid Transplant for Hypoparathyroidism (PATH Trial)

N/A
Recruiting
Led By Brenessa Lindeman, MD, MEHP
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individual diagnosed with hypocalcemia secondary to hypoparathyroidism due to prior anterior cervical neck surgery resulting in hypoparathyroidism
Individual diagnosed with hypocalcemia secondary to hypoparathyroidism due to congenital absence or malformation of parathyroid glands during development
Must not have
Dependence on nursing home or other long-term care provider
Seropositivity for HIV, HBV core antibody or antigen, HCV, HTLV-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-operatively
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with a severe, yet treatable, case of low calcium levels. The transplant would be coming from a donor.

Who is the study for?
This trial is for adults aged 18-80 with hypoparathyroidism caused by neck surgery, congenital issues, or treatment failure. They must have had the condition for at least a year and live near Birmingham. Participants need to speak English and commit to the trial's process. Exclusions include active cancer (except skin), severe heart/liver/kidney/brain diseases, uncontrolled diabetes, clotting disorders, psychiatric illness, osteoporosis, allergies to immunosuppressants, non-adherence to medical therapies.
What is being tested?
The UAB PATH trial is testing parathyroid allotransplantation as a new treatment option for patients with medically refractory hypocalcemia due to hypoparathyroidism. This innovative procedure aims to provide relief where other treatments have failed.
What are the potential side effects?
Potential side effects may include reactions related to immunosuppressive drugs such as Thymoglobulin® and tacrolimus like increased infection risk, liver or kidney dysfunction. Specific side effects of parathyroid transplantation are not listed but could involve complications from surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have low calcium due to a neck surgery that affected my parathyroid glands.
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I have low calcium due to underdeveloped parathyroid glands.
Select...
I have low calcium due to hypoparathyroidism and treatments haven't worked, affecting my daily life.
Select...
I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I rely on a nursing home or long-term care for my daily needs.
Select...
I have tested positive for HIV, hepatitis B, hepatitis C, or HTLV-1.
Select...
I have major difficulties with daily activities or thinking clearly and do not have someone to help me regularly.
Select...
I have cancer, but it's not skin cancer.
Select...
I do not have severe heart, liver, kidney diseases, uncontrolled diabetes, or bleeding disorders.
Select...
I have severe osteoporosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Calcium supplementation
Parathyroid transplant function
Secondary study objectives
Immunosuppression-related adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,647 Previous Clinical Trials
2,342,386 Total Patients Enrolled
Brenessa Lindeman, MD, MEHPPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Parathyroid Allotransplantation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05114980 — N/A
Hypoparathyroidism Research Study Groups:
Hypoparathyroidism Clinical Trial 2023: Parathyroid Allotransplantation Highlights & Side Effects. Trial Name: NCT05114980 — N/A
Parathyroid Allotransplantation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114980 — N/A
~3 spots leftby Jan 2027
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