Parathyroid Allotransplant for Hypoparathyroidism

(PATTH Trial)

Overseen By Rodney Rogers

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Peter Stock

Must be taking: Activated vitamin D, Oral calcium

Must not be taking: Investigational agents

Disqualifiers: Diabetes, Hypertension, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Peter Stock, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hypoparathyroidism, confirmed by low calcium and PTH levels. Participants must be able to consent and follow the study's procedures. They should require high doses of vitamin D and calcium or be on PTH injections but still have symptoms. People with a history of immunodeficiency or outdated vaccinations cannot join.

Inclusion Criteria

I meet all the required conditions for the study.

I can sign and follow the study's requirements.

I have low calcium and PTH levels, need high doses of vitamin D and calcium, or use PTH injections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo parathyroid allotransplant to treat hypoparathyroidism

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Parathyroid Allotransplant

Trial Overview The trial is testing if transplanting parathyroid tissue from deceased donors into a patient's forearm can normalize their serum calcium and phosphorus levels, potentially improving hypoparathyroidism treatment.

How Is the Trial Designed?

Group I: Parathyroid Allotransplant Experimental Treatment 1 Intervention

Parathyroid Allotransplant to treat hypoparathyroidism

Who Is Running the Clinical Trial?

Peter Stock

Lead Sponsor

Trials

1

Recruited

8+