In a significant advancement for Sjögren's disease treatment, researchers at the University of Wisconsin School of Medicine and Public Health have initiated a groundbreaking clinical trial using personalized cell therapy to treat salivary gland dysfunction. The trial marks a novel approach to addressing this challenging autoimmune condition that predominantly affects moisture-producing glands throughout the body.
Julianne McGowan, the trial's first participant, has struggled with severe dry mouth (xerostomia) caused by Sjögren's disease. "Early on, before I knew what it was, I'd drink an entire glass of water and still feel thirsty, thinking there was no amount of water I could drink to prevent being thirsty," McGowan described her experience before receiving treatment.
Understanding the Unmet Medical Need
Sjögren's disease, which affects women eight times more frequently than men, currently has no FDA-approved treatments. Existing therapeutic candidates in development primarily target active inflammation, leaving a significant gap in addressing chronic damage to the salivary glands.
Dr. Sara McCoy, assistant professor of medicine at UW School of Medicine and Public Health and principal investigator, explains, "The current standard of care is not addressing the root cause of dry mouth for these patients. With this cell therapy, we are hopeful we can do more than offer temporary relief and give these people back these critical human functions."
Innovative Treatment Approach
The experimental therapy involves:
- Extracting stem cells from the patient's bone marrow
- Activating these cells in the PACT cell manufacturing lab
- Injecting the enhanced cells directly into the salivary glands
This Phase 0 trial will enroll six patients initially, with plans to expand into a larger Phase 1 trial to establish safety and optimal dosing. The research team will monitor participants for approximately two years to evaluate long-term outcomes.
Early Promise
While the primary objective of this early-phase trial is safety assessment, the first patient has reported encouraging results. "I had been taking several lozenges a day to help with my symptoms, but after the treatment I used them once or twice a week," McGowan shared.
The trial is currently open to adults 18 and older with either Sjögren's disease or graft-versus-host disease, both conditions that severely impact saliva production. The study represents a collaboration between the UW School of Medicine and Public Health and UW Health's Program for Advanced Cell Therapy (PACT).
Impact on Patient Quality of Life
Severe dry mouth significantly impacts daily activities, including eating and speaking, and can lead to serious dental complications. Prior to treatment, patients typically rely on constant hydration and special lozenges to manage their symptoms. The development of this cell therapy represents a potential paradigm shift in treatment approach, moving from symptom management to addressing underlying tissue damage.
McGowan emphasizes the importance of raising awareness about Sjögren's disease: "I want to increase awareness of the disease and what the symptoms are so others don't suffer." Her participation in the trial not only contributes to potential therapeutic advancement but also helps highlight the challenges faced by Sjögren's disease patients.
