Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome

Summary

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.

Timeline

Start

2026-12-01

Primary completion

2027-05-01

Completion

2027-12-01

Publications

• Background Habibi A, Khosravi A, Soleimani M, Nejabat M, Dara M, Azarpira N. Efficacy of topical mesenchymal stem cell exosome in Sjogren's syndrome-related dry eye: a randomized clinical trial. BMC Ophthalmol. 2025 May 20;25(1):299. doi: 10.1186/s12886-025-04078-9.
• Background Desouky HO, Halawa AM, Hassan R. Role of Mesenchymal Stem Cell Exosomes and Injectable Platelet Rich Fibrin on Structure and Function of Submandibular Salivary Gland of Aged Albino Rats. Saudi Dent J. 2025 Sep 9;37(7-9):46. doi: 10.1007/s44445-025-00056-5.
• Background Jeon Y, Shin S, Cheon EJ, Kwon Y, Beak JU, Lee HJ, Park J, Chung SH. The Effects of Mesenchymal Stem Cell-Derived Exosomes on the Attenuation of Dry Eye Disease in Sjogren Syndrome Animal Model. Tissue Eng Regen Med. 2025 Dec;22(8):1173-1183. doi: 10.1007/s13770-025-00755-4. Epub 2025 Sep 8.
• Results Li ZZ, Zhang M, Wang X, Qi HZ, Wang YY, Cao JY, Huang GL, Zhang NN. Therapeutic effects of human amniotic mesenchymal stem cell-derived exosomes on stem cell proliferation in irradiated salivary glands via the Wnt pathway. Open Life Sci. 2026 Feb 18;21(1):20251277. doi: 10.1515/biol-2025-1277. eCollection 2026 Jan.

Drugs

Indications