Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06961071

Parathyroid Allotransplant for Treatment of Hypoparathyroidism

Led by Peter Stock · Updated on 2026-02-27

3

Participants Needed

1

Research Sites

104 weeks

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

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

Official Title

Parathyroid Allotransplant for Treatment of Hypoparathyroidism

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Able to provide written informed consent and comply with study procedures
  • Clinical history and lab evidence of hypoparathyroidism with low or inappropriately normal PTH on two occasions at least 2 weeks apart and 12 months after surgery
  • Requires treatment with activated vitamin D (at least 0.5 mcg calcitriol) and oral calcium (at least 800 mg) daily, or currently on parathyroid hormone replacement injections with ongoing symptoms due to low calcium
  • No history of immunodeficiency that could be worsened by immunosuppression
  • Up to date immunizations per UCSF standard for organ transplantation, including influenza, pneumococcal, hepatitis B, and tetanus-diphtheria vaccines
Not Eligible

You will not qualify if you...

  • Presence of donor-specific anti-HLA antibodies detected by specific assays
  • Intolerance to any immunosuppressive drugs used in the study
  • Poorly controlled diabetes with A1C greater than 8%
  • High blood pressure (systolic >140 mmHg or diastolic >90 mmHg) not controlled by medication
  • Significant kidney or liver dysfunction
  • For women: positive pregnancy test, currently breastfeeding, or unwilling to use effective contraception during and 4 months after study
  • For men: intention to father a child during and 4 months after study or unwillingness to use contraception
  • Active infections including hepatitis B, hepatitis C, HIV, tuberculosis, or recent serious fungal/opportunistic infections within 1 year
  • Current cancer or treated cancer with over 50% estimated recurrence risk in 5 years, except fully removed skin cancers
  • Known active alcohol or substance abuse
  • Active peptic ulcers, symptomatic gallstones, or portal hypertension
  • Use of investigational agents within 4 weeks or 5 half-lives before screening
  • Receipt of live attenuated vaccines within 2 months of enrollment
  • Any medical condition or investigator judgment that poses risk or interferes with study
  • Positive polyoma (BK) virus test at screening
  • Chronic kidney disease stage 4 or 5
  • Severe heart disease including recent heart attack, evidence of ischemia, low heart pump function, or valve replacement
  • Substance use interfering with study compliance
  • Other medical problems that may increase risks or affect study data quality as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

C

Crystal Loucel, MPH, MS, RN

CONTACT

R

Rodney Rogers

CONTACT

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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