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Parathyroid Allotransplant for Treatment of Hypoparathyroidism | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Parathyroid Allotransplant for Treatment of Hypoparathyroidism

Parathyroid Allotransplant for Treatment of Hypoparathyroidism: PATTH

NCT06961071•Peter Stock

Summary

This study is being done to see if transplanting parathyroid tissue into the forearm will help hypo-parathyroid patients achieve parathyroid hormone (PTH) levels that would help normalize their serum calcium and phosphorus levels. The parathyroid tissue used in this study will come from cadaveric tissues that were donated at the time of the death of the donor(s).

Detailed Description

The company that makes the parathyroid hormone NATPARA will no longer be making the product by the end of 2024 which is one of the reasons the investigators are doing this study: to see if parathyroid transplantation is another way to treat hypoparathyroidism. This procedure is investigational and one of the first times the procedure is being done in humans. It is not approved by the FDA.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects age 18 or older.
•2. Subjects who are able to provide written informed consent and to comply with study procedures.
•3. Clinical history and laboratory data compatible with HypoPT as defined by hypocalcemia and documented PTH levels either inappropriately normal or below the normal range on two occasions greater than 2 weeks apart and 12 months after surgery, requiring treatment with activated vitamin D (≥0.5 mcg calcitrol) and oral calcium (≥800mg) daily, or currently on PTH (1-84), PTH (1-34), palopegteriparatide or other recombinant parathyroid hormone replacement injections with ongoing symptomatology due to hypocalcemia and variable degree of biochemical control.
•4. No history of immunodeficiency (e.g., opportunistic infections) that could be exacerbated by immunosuppression.
•5. Up to date immunizations per the University of California, San Francisco (UCSF) standard of care for organ transplantation, including influenza, pneumococcal, hepatitis B, and tetanus-diptheria

Exclusion Criteria

•1. Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
•2. Intolerance to any drug that will be used as part of the IS regimen.
•3. Poorly controlled diabetes with an A1C of \>8%.
•4. Blood Pressure (BP): systolic blood pressure (SBP) \> 140mmHg or DBP \>90 mmHg despite treatment with antihypertensive agents. If the BP is greater than 140/90 chart review and discussion with the patient will be done to establish that BP is in good control.
•6. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
•7. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Quantiferon gold assay will be used to determine TB infection.
•8. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection or other opportunistic infection within 1 year prior to study entry.
•9. Current malignancy or treated malignancy with estimated recurrence rate \>50% at 5 years, except for completely resected squamous or basal cell carcinoma of the skin
•10. Known active alcohol or substance abuse.
•11. Active infections (except mild skin and nail fungal infections).
+14 more criteria

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

January 15, 2026

Primary Completion Date

January 15, 2028

Completion Date

January 15, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

HypoparathyroidismHypoparathyroidism PostproceduralHypoparathyroidism Post-surgical

Interventions

Parathyroid Allotransplant

BIOLOGICAL

Contacts

Crystal Loucel, MPH, MS, RN

CONTACT

415-476-3229 Crystal.Loucel@ucsf.edu

Rodney Rogers

CONTACT

415-514-6454 Rodney.Rogers@ucsf.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Parathyroid Allotransplant for Treatment of Hypoparathyroidism

Inclusion Criteria

Exclusion Criteria

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