Plain-English translation of NCT06805448 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing a new approach to treating severe dry mouth caused by Sjögren's syndrome—an autoimmune disease where your immune system attacks your salivary glands. Researchers will inject allogeneic adipose-derived mesenchymal stem cells (stem cells harvested from healthy donor fat tissue) directly into your salivary glands to see if this treatment can help your glands produce more saliva and reduce your dry mouth symptoms. Half of participants will receive the actual stem cell treatment, and half will receive a placebo (salt water injection) to compare results.
Current dry mouth treatments only provide temporary relief lasting from minutes to a few hours, so patients need better long-term solutions. This medication has shown promising results in previous studies of patients whose dry mouth was caused by cancer radiation therapy—producing a 30–50% increase in saliva—but has never been tested in Sjögren's patients specifically.
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If you join this study, you will receive either the stem cell injection or a placebo injection directly into your salivary glands—a quick procedure performed by the research team. You will then be monitored for 12 months with follow-up visits where researchers will measure your saliva production and ask about your symptoms to see whether the treatment has improved your dry mouth. The study involves 40 participants total, and you will be randomly assigned to either the active treatment or placebo group.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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