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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transplanting parathyroid tissue from donors into the forearm can help individuals with hypoparathyroidism better manage their calcium and phosphorus levels. Known as Parathyroid Allotransplant, the treatment uses donated tissue to potentially increase parathyroid hormone levels, stabilizing these crucial minerals in the body. This trial suits individuals who have experienced hypoparathyroidism for at least a year and are currently taking high doses of vitamin D and calcium or using PTH injections but still experience symptoms related to low calcium levels. As a Phase 1, Phase 2 trial, the research focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in hypoparathyroidism treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using investigational agents, a washout period (time without taking certain medications) may be required. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that the parathyroid allotransplant is likely to be safe for humans?

Research has shown that transplanting parathyroid tissue might safely and effectively treat hypoparathyroidism. This procedure helps control calcium and phosphorus levels in the body. Studies suggest it could offer a long-term solution for patients who don't respond well to standard treatments like calcium and vitamin D supplements.

Although this treatment remains in the early stages, its testing in people indicates it has passed initial safety checks. So far, studies have reported no major safety issues, which is promising. However, researchers continue to monitor for any possible side effects. Participants should discuss the risks and benefits with their healthcare providers to make informed decisions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about parathyroid allotransplant for hypoparathyroidism because it offers a potentially long-lasting solution by directly transplanting healthy parathyroid tissue. Unlike current treatments, which often involve daily supplements of calcium and vitamin D to manage symptoms, this approach aims to restore the body's natural ability to regulate calcium levels. This could mean fewer pills and a more stable condition for patients, ultimately improving their quality of life.

What evidence suggests that parathyroid allotransplant might be an effective treatment for hypoparathyroidism?

Studies have shown that transplanting parathyroid tissue from a donor can help restore normal parathyroid function. In this trial, participants will receive a Parathyroid Allotransplant, which might offer a one-time cure for hypoparathyroidism by enabling the body to produce the necessary parathyroid hormone (PTH). PTH plays a crucial role in maintaining normal calcium and phosphorus levels in the blood. Research suggests that this treatment is potentially safe and promising as a long-term solution for individuals with permanent hypoparathyroidism. By transplanting parathyroid tissue, the goal is for patients to achieve healthier PTH levels, leading to better calcium balance. ^{1 2 3 4 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8953572/

Parathyroid Allotransplantation: A Systematic Review - PMC Parathyroid allotransplantation by design is a one-time cure through its restoration of the parathyroid function and, therefore, could be the solution.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06961071

NCT06961071 | Parathyroid Allotransplant for Treatment of ... This study is being done to see if transplanting parathyroid tissue into the forearm will help hypo-parathyroid patients achieve parathyroid hormone (PTH) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961021004050

Parathyroid allotransplantation for the treatment of ... Parathyroid allotransplantation presents a potentially safe and effective therapeutic option for the definitive treatment of permanent hypoparathyroidism.

4. gs.amegroups.org gs.amegroups.org/article/view/17084/html

Short and long-term impact of parathyroid autotransplantation ... Parathyroid autotransplantation has been demonstrated to be effective, clinically and biochemically, with a functional graft survival rate of 93% (9). However, ...

5. jes-online.org jes-online.org/pdf/10.16956/jes.2025.25.1.1

Advancements and Clinical Strategies in Parathyroid ... Parathyroid transplantation holds significant promise as a treatment for hypoparathyroidism. Further research and clinical trials are warranted ...

6. academic.oup.com academic.oup.com/ejendo/article/184/5/R165/6653970

Postsurgical hypoparathyroidism: current treatments and ... A prospective trial to assess the efficacy of parathyroid allotransplantation in patients with severely symptomatic protracted post-surgical hypoparathyroidism ...