Chronic Dry mouth?
Dry mouth, salivary hypofunction, xerostomia: whatever you call it, it can make life difficult. If you have chronic dry mouth due to radiation treatments that took place 5 or more years ago, this clinical study might be right for you.
Participants will undergo an investigational, one-time treatment that may help improve symptoms of xerostomia.
See if You Qualify
Fill out the form below to see if you meet the basic study requirements.
To participate in the xerostomia study, you must:
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
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.