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

ConditionsSjogren Syndrome Xerostomia Exosome

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorBanu Erkal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

exosomes derived from human umbilical cord mesenchymal stem cells
Biological/Vaccine
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/Vaccine
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.
Placebo
Other intervention
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.

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: ExosomeExperimental treatment 1 intervention

Group B: Mesenchymal Stem CellsExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Banu Erkal

Lead sponsor

Yeditepe University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: