Recruiting

Parathyroid Allotransplant

Sponsor:

Karen Devon

Code:

NCT06499246

Conditions

Hypoparathyroidism Postprocedural

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Donor Parathyroid

Study Details

Brief summary:

Hypoparathyroidism following thyroid surgery presents significant challenges, often leading to debilitating symptoms and reduced quality of life despite conventional treatment. Having now reported the first successful case of a deceased donor fresh tissue parathyroid allotransplant with immunosuppression in a transplant-naive recipient, the purpose of this study is to further assess the safety and efficacy of this procedure in patients with severe intractable post-surgical hypoparathyroidism.

Conditions

Hypoparathyroidism Postprocedural

Study ID

NCT06499246

Start date

Jul, 2024

Status verified date

Jul, 2024

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Prior total thyroidectomy
  • Symptomatic hypocalcemia (numbness, tingling, or other neurologic symptoms) requiring daily high dose calcium (greater than 2000 mg per day) and vitamin D (greater than 2 mcg of calcitriol per day) supplementation and/or intermittent IV calcium infusion.
  • Biochemical blood test consistent with hypoparathyroidism
  • Failed medical management (>1 year of post-thyroidectomy hypoparathyroidism treated medically with persistent biochemical disease and symptoms)
  • Patient meets current standards for receiving an organ transplant (e.g. no active infection, no malignancy, no contraindications to immunosuppression or surgery)

Exclusion Criteria:

  • <18 years old male or female
  • Current pregnancy
  • Advanced stage 3-4 thyroid cancer
  • Contraindication to surgery or immunosuppression
  • Malignancy with contraindication to transplant:

1. Certain active malignancies are not a contraindication to transplant such as prostate cancer or lymphoproliferative disease in remission, and locoregional skin malignancies such as melanoma will be transplant candidates (outlined in Preexisting melanoma and hematological malignancies, prognosis, and timing to solid organ transplantation: A consensus expert opinion statement by Al-Adra et al respectively).
2. Remote malignancies with successful treatment will not preclude patients from inclusion in the study. Dependent upon the malignancy risk level a minimal time from treatment will be required as established by the consensus recommendations outlined in Pretransplant solid organ malignancy and organ transplant candidacy: A consensus expert opinion statement by Al-Adra et al.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Parathyroid Transplant

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.

Interventions

Donor Parathyroid

Once a potential donor becomes available, the transplant team will assess if the donor is a match for our study participant using standardized transplantation protocols that include serology blood tests completed in the pre-operative setting. If the donor is a match, the procurement team will procure all parathyroid tissue using standard surgical techniques. The specimen will be kept in organ preservation solution for transport and transported to the operating room. The recipient (study participant) will be admitted to the hospital under and taken to the operating room for the surgical procedure. Once the procurement team arrives with the parathyroid tissue the procedure will be performed under local anesthesia using a well-established technique, for parathyroid auto transplant, of implanting parathyroid tissue in the non-dominant brachioradialis muscle. Immunosuppression medication protocols will be initiated.

Primary outcome measure

  • Maintain calcium levels without standard calcium replacement treatment. [ Time Frame: Pre-operatively and then at 4 weeks, 3 months and 12 months post-operatively ]

Central Contacts and Locations

Central contacts

Karen Devon, MD, MSc, FRCSC, FACS

416-323-6400karen.devon@wchospital.ca

Esther Lee, BScN

416-340-4800esther.lee@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5S1B2

Contacts

Karen Devon, MD, MSc, FRCSC, FACS

416236400karen.devon@wchospital.ca

More Information

Sponsor

Karen Devon

Last update posted

Jul 12, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Karen Devon on 2024-07-12.