NCT06961071 Parathyroid Allotransplant for Treatment of Hypoparathyroidism
| NCT ID | NCT06961071 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peter Stock |
| Condition | Hypoparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 3 participants in total. It began in 2026-01-15 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria Only subjects who meet all of the following criteria are eligible for enrollment. 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 Subjects who meet any of the following criteria are not eligible for enrollment 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. 5. Other exclusion criteria including significant renal or hepatic dysfunction 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). 12. Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension. 13. 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. 14. 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. 15. Administration of live attenuated vaccine(s) within 2 months of enrollment. 16. Any medical condition that, in the opinion of the investigator, will interfere with safe study completion. 17. Positive screen for polyoma (BK) viremia at time of screening. 18. CKD stage 4 or 5 19. Severe co-existing cardiac disease, characterized by any one of these conditions: 1. Recent myocardiol infarction (MI) (within 1 year) 2. Evidence of ischemia on functional cardiac exam within the last year. These include persantine thallium stress test and/or coronary angiogram which will be performed in any patient with a history of an MI 3. Left ventricular ejection fraction \< 45% 4. Valvular disease requiring replacement with prosthetic valve 20. Substance use that in the opinion of the investigator would interfere with compliance with the study requirements. 21. Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Contact & Investigator
Peter Stock, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06961071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06961071 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06961071 currently recruiting?
Yes, NCT06961071 is actively recruiting participants. Contact the research team at Crystal.Loucel@ucsf.edu for enrollment information.
Where is the NCT06961071 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06961071 clinical trial?
NCT06961071 is sponsored by Peter Stock. The principal investigator is Peter Stock, MD, PhD at University of California, San Francisco. The trial plans to enroll 3 participants.