Effect of Exosome and Mesenchymal Stem Cell Injections Into the Submandibular Glands on Salivary Gland Function in Primary Sjögren Syndrome: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exosome
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.
干预措施: exosomes derived from human umbilical cord mesenchymal stem cells (Biological)
Mesenchymal Stem Cells
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.
干预措施: Mesenchymal Stem Cells (MSC) (Biological)
Placebo
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.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy
时间窗: Baseline to Month 6
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.
次要结局
- Change in Xerostomia Inventory Score(3 months)
研究者
Banu Erkal
Otorhinolaryngology Resident
Yeditepe University Hospital