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

NCT07838454 | Not Yet Recruiting Phase 2

• 1 other identifier: SJGEXO2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren Syndrome; Xerostomia; Exosome

Keywords

sjögren syndrome; xerostomia; exosome

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy

  Change in salivary flow rate, measured by salivary gland scintigraphy. Salivary flow rate will be expressed in mL/min. Baseline values obtained from the participants' existing sialoscintigraphy performed at Yeditepe University will be compared with the values obtained at Month 6.

  Baseline to Month 6

Secondary Outcomes (1)

• Change in Xerostomia Inventory Score

  3 months

Study Arms (3)

Exosome

EXPERIMENTAL

Participants will receive exosome injections into both submandibular glands. The exosome preparation is derived from umbilical cord-derived mesenchymal stem cells and contains 5 billion particles per 1 mL. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.

Biological: exosomes derived from human umbilical cord mesenchymal stem cells

Mesenchymal Stem Cells

EXPERIMENTAL

Participants will receive mesenchymal stem cell injections into both submandibular glands. The mesenchymal stem cells are derived from umbilical cord tissue and produced by Yeditepe University at a concentration of 10 million MSCs per 1 mL. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.

Biological: Mesenchymal Stem Cells (MSC)

Placebo

PLACEBO COMPARATOR

Participants will receive serum physiologic (saline) injections into both submandibular glands. Each submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.

Other: Placebo

Interventions

exosomes derived from human umbilical cord mesenchymal stem cells BIOLOGICAL

Exosomes derived from umbilical cord-derived mesenchymal stem cells. The preparation is a cell-free extracellular vesicle product containing 5 billion particles per 1 mL. Each participant will receive 0.5 mL in each submandibular gland at two injection sites. Two applications will be performed, with the second application 2 weeks after the first.

Exosome

Mesenchymal Stem Cells (MSC) BIOLOGICAL

Umbilical cord-derived mesenchymal stem cells (MSCs), produced by Yeditepe University, at a concentration of 10 million MSCs per 1 mL. Each bilateral submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.

Mesenchymal Stem Cells

Placebo OTHER

Serum physiologic (saline). Each bilateral submandibular gland will receive 0.5 mL at two injection sites per application. Two applications will be performed, with the second application 2 weeks after the first.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of primary Sjögren syndrome
• Salivary gland hypofunction and/or xerostomia
• Previous sialoscintigraphy performed at Yeditepe University as part of the diagnosis of primary Sjögren syndrome
• Willingness to provide written informed consent
• Acceptance of the planned bilateral submandibular gland applications and follow-up

You may not qualify if:

• Age younger than 18 years
• No previous sialoscintigraphy or inability to undergo sialoscintigraphy
• Presence of another disease, in addition to primary Sjögren syndrome, that may cause dry mouth
• Use of medications that may cause dry mouth
• Refusal to provide informed consent
• Refusal to undergo the planned bilateral submandibular gland applications or follow-up

Sponsors & Collaborators

• Banu Erkal: lead

Study Sites (1)

Yeditepe University Hospital

Istanbul, Kadikoy, 34718, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 40394561 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.

  PMID: 40924257 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.

  PMID: 40924385 BACKGROUND

• 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.

  PMID: 41726564 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yavuz Selim Pata, Professor

  Yeditepe University Hospital

  STUDY DIRECTOR

• Banu Erkal, Resident

  Yeditepe University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Banu Erkal, MD

CONTACT

+905319867061; banurkl@gmail.com

Yavuz Selim Pata, Professor

CONTACT

+905337602070; yavuzpata@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Otorhinolaryngology Resident

Model Details: Participants will be randomly assigned to one of three parallel groups: exosome, mesenchymal stem cell, or placebo. Each group will receive two applications to the bilateral submandibular glands, with the second application performed 2 weeks after the first.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)