Actively Recruiting
Parathyroid Allotransplant for Treatment of Hypoparathyroidism: PATTH
Led by Peter Stock · Updated on 2026-02-27
3
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peter Stock
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether transplanting parathyroid tissue into the forearm can help people with hypoparathyroidism reach parathyroid hormone (PTH) levels that normalize calcium and phosphorus in the blood. This study is motivated by the upcoming discontinuation of the parathyroid hormone drug NATPARA by its manufacturer. This investigational procedure uses donated parathyroid tissue from deceased donors and is one of the first times this approach is being tested in humans, without FDA approval yet. Participants will receive a parathyroid allotransplant, where donated parathyroid tissue is transplanted to treat hypoparathyroidism. The study is conducted in phases 1 and 2 to assess this new biological intervention. The plan includes monitoring the transplant's ability to restore PTH levels, with no placebo or comparator group mentioned. During the study, participants will be followed for one year to measure intact PTH levels and watch for serious adverse events. Researchers will also track the doses of oral calcium, activated vitamin D, and parathyroid hormone replacement therapy required. The study involves regular clinical and laboratory evaluations to assess safety, hormone control, and supplement needs, ensuring participant health and treatment monitoring throughout the year.
CONDITIONS
Brief Title
Parathyroid Allotransplant for Treatment of Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to provide written informed consent and follow study procedures
- Diagnosis of hypoparathyroidism confirmed by low calcium and PTH levels at least 12 months after surgery
- Requires daily treatment with activated vitamin D (at least 0.5 mcg calcitrol) and oral calcium (at least 800 mg) or ongoing parathyroid hormone replacement injections with symptoms
- No history of immunodeficiency and up to date on standard organ transplant immunizations including influenza, pneumococcal, hepatitis B, and tetanus-diphtheria vaccines
You will not qualify if you...
- Presence of donor-specific anti-HLA antibodies
- Intolerance to immunosuppressive drugs
- Poorly controlled diabetes with A1C above 8%
- Blood pressure above 140/90 mmHg despite treatment
- Significant kidney or liver dysfunction
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and 4 months after study
- Active infections including hepatitis B, hepatitis C, HIV, tuberculosis, or opportunistic infections within 1 year
- Current or high-risk malignancy except certain skin cancers
- Active alcohol or substance abuse
- Active peptic ulcer disease, symptomatic gallstones, or portal hypertension
- Use of investigational agents within 4 weeks prior to screening
- Any condition that may interfere with safe study completion or compliance
- Positive polyoma (BK) viremia at screening
- Chronic kidney disease stage 4 or 5
- Severe cardiac disease including recent heart attack, ischemia, low ejection fraction, or prosthetic heart valve
- Substance use interfering with study compliance
- Other medical problems posing additional risks or affecting data quality per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks (1 year)
Participants receive a parathyroid allotransplant to treat hypoparathyroidism and are monitored for safety and effectiveness.
Regular visits throughout the year to monitor hormone levels and safety
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
C
Crystal Loucel, MPH, MS, RN
R
Rodney Rogers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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