Parathyroid Allotransplant for Treatment of Hypoparathyroidism

NCT06961071 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 23-40309
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypoparathyroidism; Hypoparathyroidism Postprocedural; Hypoparathyroidism Post-surgical

Keywords

hypoparathyroidism; parathyroid hormone; PTH; serum calcium; phosphorus

Outcome Measures

Primary Outcomes (2)

• Levels of intact PTH

  The primary efficacy endpoint is attainment of levels of intact PTH levels that are in the normal range and at least double the baseline intact PTH level at one year following the PTG transplant from a single donor.

  From baseline to week 52 (year 1)

• Incidence of Serious Adverse Events

  The primary safety endpoints are the incidence of serious adverse events related to the transplant procedure or immunosuppression, incidence of post- transplant infections and malignancies, incidence of de novo sensitization.

  From baseline to Year 1

Secondary Outcomes (3)

• Dose of oral calcium supplements and calcitrol

  From baseline to week 52 (year 1)

• Dose of subcutaneous parathyroid hormone (PTH) replacement therapy

  From baseline to week 52 (year 1)

• PTH replacement therapy

  From baseline to week 52 (year 1)

Other Outcomes (1)

• Quality of Life measurement

  From baseline to Year 1

Study Arms (1)

Parathyroid Allotransplant

EXPERIMENTAL

Parathyroid Allotransplant to treat hypoparathyroidism

Biological: Parathyroid Allotransplant

Interventions

Parathyroid Allotransplant BIOLOGICAL

Parathyroid Allotransplant

Parathyroid Allotransplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 18 or older.
• Subjects who are able to provide written informed consent and to comply with study procedures.
• 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.
• No history of immunodeficiency (e.g., opportunistic infections) that could be exacerbated by immunosuppression.
• 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

You may not qualify if:

• 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
• Intolerance to any drug that will be used as part of the IS regimen.
• Poorly controlled diabetes with an A1C of \>8%.
• 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.
• 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.
• Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Quantiferon gold assay will be used to determine TB infection.
• Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection or other opportunistic infection within 1 year prior to study entry.
• 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
• Known active alcohol or substance abuse.
• Active infections (except mild skin and nail fungal infections).
• Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension.
• Use of any investigational agents within 4 weeks of screening or 5 half-lives of the investigational product/ medication, whichever is longer. Investigational products with prolonged invivo effects will require a wash-out period that aligns with the biochemical and physiologic effects of the agent prior to the initiation of this protocol. If the half life of the experimental agent is not known, participation in the study will be addressed with the study team and documented in the study record.
• Any investigational agents/products that could potentially interfere with the safety and/or efficacy of the procedure being studied will be addressed with the study team and documented in the study record.
• Administration of live attenuated vaccine(s) within 2 months of enrollment.
• Any medical condition that, in the opinion of the investigator, will interfere with safe study completion.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Peter Stock: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Peter Stock, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Loucel, MPH, MS, RN

CONTACT

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

Rodney Rogers

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery (MD, PhD)

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Upon completion of the clinical study report and publication of the trial outcomes.
• Access Criteria: Researchers may contact Dr. Peter Stock, MD, PhD at UCSF by contacting the primary contact listed in this CT.GOV record.

Locations

US (1)