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Procedure

Parathyroid Transplant for Hypoparathyroidism

N/A

Recruiting

Led By Karen Devon, MD, MSc, FRCSC, FACS

Research Sponsored by Karen Devon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed medical management of post-thyroidectomy hypoparathyroidism

Prior total thyroidectomy

Must not have

Contraindication to surgery or immunosuppression

Malignancy with contraindication to transplant:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks, 3 months and 12 months post-operatively

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study a new treatment for severe hypoparathyroidism that can occur after thyroid surgery. The treatment involves transplanting parathyroid tissue from a deceased donor to the patient,

Who is the study for?

This trial is for individuals with severe hypoparathyroidism that persists after thyroid surgery and doesn't respond well to standard treatments. Participants must be struggling with symptoms despite conventional therapy.

What is being tested?

The study is testing the safety and effectiveness of transplanting parathyroid tissue from a deceased donor into patients who have not responded to other treatments for severe post-surgical hypoparathyroidism.

What are the potential side effects?

Potential side effects may include complications related to surgery, reactions to the new parathyroid tissue, and issues arising from immunosuppressive drugs needed to prevent rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My low calcium levels after thyroid surgery haven't improved with medication.

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I have had my entire thyroid removed.

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I need high doses of calcium and vitamin D or IV calcium because of low blood calcium levels.

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I am eligible for an organ transplant according to current guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have surgery or take drugs that weaken my immune system.

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My cancer cannot be treated with a transplant.

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I am under 18 years old.

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My thyroid cancer is at an advanced stage (3 or 4).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks, 3 months and 12 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks, 3 months and 12 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 3 months 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

Maintain calcium levels without standard calcium replacement treatment.

Secondary study objectives

Rate of surgical complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Parathyroid TransplantExperimental Treatment1 Intervention

Patients with permanent refractory hypoparathyroidism after total thyroidectomy will be entered in this study to undergo parathyroid transplantation from a neurologically deceased donor. Inclusion criteria are patients who have had a prior total thyroidectomy with both biochemical hypoparathyroidism and symptomatic hypocalcemia (numbness, tingling, or other neurologic symptoms) requiring daily high dose calcium (greater than 2000 mg per day), vitamin D (greater than 2 mcg of calcitriol per day) supplementation and/or intermittent IV calcium infusion. Patients for inclusion must have failed this medical management after at least 1 year of treatment and meet standard criteria for receiving organ transplant.

0 / 8Eligibility criteria met