See if You Qualify

Fill out the form below to see if you meet the basic study requirements.

What’s Involved?

To participate in the xerostomia study, you must:

  • Fill out the eligibility questionnaire above
  • Get in touch with study staff to answer further qualifications questions and schedule your first screening visit
  • Complete a 3-5 day stay at the study center to receive the investigational treatment (travel, lodging, and meals provided for participant and partner)
  • Stay engaged with the study by attending follow-up screening visits (10 total over a 5-year period).

What is the treatment?

This investigational treatment is minimally invasive and involves using a fine catheter to deliver the vector into the salivary gland through the mouth. This is done just once and with the intended outcome being increasing water permeability where the salivary gland is non-functional. The 3–5-day stay is for continued monitoring of participants after the investigational treatment.

Study visits over the following years will be simple outpatient visits for additional tests/screenings. After the 3-year period, there are two additional visits, once per year for safety exams as required by the FDA.

Frequently asked questions

What is the goal of this treatment?

The aim of the trial is to determine the safety of inserting the gene for the human aquaporin water channel (hAQP1) locally into the salivary glands of RIX patients and to measure changes in salivary flow resulting from the introduction of this channel.

Rather than replacing a gene that is defective or missing in a monogenic disease, gene therapy can also provide a therapeutic impact by adding a particular new gene function to cells and thereby change cell behavior and function. This is the aim of our salivary gland programs, where our investigational treatments are designed to promote water to flow through otherwise impermeable cells in damaged salivary glands and therefore increase saliva flow into the mouth.

Does it work?

While research is ongoing, preliminary results have been positive and can be viewed HERE.

Where is the study center located?

NIH Bethesda, Maryland campus. Participants will be admitted to the Clinical Center inpatient unit for the 3 days surrounding the treatment.

Can I bring my partner to the study center?

Yes, lodging, and meals are provided for participants and their partners.

Will I be reimbursed for travel?

Yes, all travel expenses will be reimbused.