BridgeMD
New treatment option for Hypoparathyroidism
Official title Parathyroid Allotransplant for Treatment of Hypoparathyroidism
ClinicalTrials.gov ID: NCT06961071
What this study is testing
What is Parathyroid Allotransplant?
Parathyroid Allotransplant is an investigational medicine, being studied as a potential treatment for hypoparathyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Only people who meet all of the following criteria are eligible for enrollment.
- people age 18 or older.
- people who are able to provide written informed consent and to comply with study procedures.
- Clinical history and laboratory data compatible with HypoPT as defined by hypocalcemia and documented PTH levels either inappropriately normal or...
- No history of immunodeficiency (e.g., opportunistic infections) that could be exacerbated by immunosuppression.
You likely can't join if
- people who meet any of the following criteria are not eligible for enrollment
- Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that...
- Intolerance to any drug that will be used as part of the IS regimen.
- Poorly controlled diabetes with an A1C of \>8%.
- Blood Pressure (BP): systolic blood pressure (SBP) \> 140mmHg or DBP \>90 mmHg despite treatment with antihypertensive agents. If the BP is greater...
- Other exclusion criteria including significant renal or hepatic dysfunction
See the full eligibility criteria
- Only people who meet all of the following criteria are eligible for enrollment.
- people age 18 or older.
- people who are able to provide written informed consent and to comply with study procedures.
- 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...
- No history of immunodeficiency (e.g., opportunistic infections) that could be exacerbated by immunosuppression.
- 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
- people who meet any of the following criteria are not eligible for enrollment
- 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
- Intolerance to any drug that will be used as part of the IS regimen.
- Poorly controlled diabetes with an A1C of \>8%.
- 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...
- Other exclusion criteria including significant renal or hepatic dysfunction
- For female people: 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 people: intent to...
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Quantiferon gold assay will be used to determine TB infection.
- Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection or other opportunistic infection within 1 year prior to study entry.
- 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
- Known active alcohol or substance abuse.
- Active infections (except mild skin and nail fungal infections).
- Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension.
- 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...
- Any investigational agents/products that could potentially interfere with the safety and/or how well it works of the procedure being studied will be addressed with the study team and documented in the study record.
- Administration of live attenuated vaccine(s) within 2 months of enrollment.
- Any medical condition that, in the opinion of the investigator, will interfere with safe study completion.
- Positive screen for polyoma (BK) viremia at time of screening.
- CKD stage 4 or 5
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- Recent myocardiol infarction (MI) (within 1 year)
- 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
- Left ventricular ejection fraction \< 45%
- Valvular disease requiring replacement with prosthetic valve
- Substance use that in the opinion of the investigator would interfere with compliance with the study requirements.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.