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

Phase 2Not Yet RecruitingNCT07838454

Banu Erkal30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sjogren Syndrome Xerostomia Exosome

Interventions

exosomes derived from human umbilical cord mesenchymal stem cellsBIOLOGICAL

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.

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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Month 6

Secondary Outcomes

Change in Xerostomia Inventory Score

Change in xerostomia severity assessed using the 11-item Xerostomia Inventory XI. Total scores range from 11 to 55, with higher scores indicating greater severity of xerostomia. The questionnaire will be administered at Month 1 and Month 3.

Time frame: 3 months