Clinical trials

This study will evaluate the effects of exosome and mesenchymal stem cell injections into the submandibular glands of adults with primary Sjögren syndrome and salivary gland dysfunction or dry mouth. A total of 30 participants will be randomly assigned to three groups: an exosome group, a mesenchymal stem cell group, or a placebo group. Both submandibular glands will receive two applications, with the second application performed 2 weeks after the first. Each gland will receive 0.5 mL of the assigned treatment at two injection sites. Exosomes will be derived from umbilical cord-derived mesenchymal stem cells, and mesenchymal stem cells will also be derived from umbilical cord tissue. The placebo group will receive saline. Previous sialoscintigraphy results obtained at Yeditepe University as part of the diagnosis of primary Sjögren syndrome will be used as the baseline assessment. The Xerostomia Inventory will be administered at months 1 and 3, and sialoscintigraphy will be repeated at month 6 to evaluate changes in salivary gland function. Each participant will be followed for 6 months.