Sjogren SyndromePhase 2NCT07838454
Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome
A Phase 2 study testing exosomes derived from human umbilical cord mesenchymal stem cells and Mesenchymal Stem Cells (MSC) in people with Sjogren Syndrome and Xerostomia, run by Banu Erkal at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjogren Syndrome, Xerostomia, Exosome
- What is being tested?
- exosomes derived from human umbilical cord mesenchymal stem cells and Mesenchymal Stem Cells (MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Yeditepe University Hospital
Istanbul, Kadikoy, 34718
Banu Erkal, MD, +905319867061, banurkl@gmail.com
banurkl@gmail.com
About this study
Official title: 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
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
- Being tested
- exosomes derived from human umbilical cord mesenchymal stem cells, Mesenchymal Stem Cells (MSC), Placebo
- Keywords
- sjögren syndrome, xerostomia, exosome
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 6
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banu Erkal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Banu Erkal, Yeditepe University Hospital
- Investigators
- Yavuz Selim Pata, Professor, Study director, Yeditepe University HospitalBanu Erkal, Resident, Principal investigator, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838454
- Sponsor's protocol ID
- SJGEXO2026
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Publications
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.
PubMed 40394561Desouky 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.
PubMed 40924257Jeon 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.
PubMed 40924385Li 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.
PubMed 41726564
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07838454
- Acronym / sponsor ID
- SJGEXO2026
- Conditions
- Sjogren Syndrome, Xerostomia, Exosome
- Keywords
- sjögren syndrome, xerostomia, exosome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Banu ErkalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exosome | Experimental | Biological: exosomes derived from human umbilical cord mesenchymal stem cellsParticipants 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. |
| Mesenchymal Stem Cells | Experimental | Biological: Mesenchymal Stem Cells (MSC)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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomes derived from human umbilical cord mesenchymal stem cellsExosomes 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. | Biological | Exosome |
| Mesenchymal Stem Cells (MSC)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. | Biological | Mesenchymal Stem Cells |
| PlaceboSerum 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. | Other | Placebo |
Primary outcome
Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy
Time frame: 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.
1 secondary outcome
Change in Xerostomia Inventory Score
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 40394561Habibi 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: PubMed 40924257Desouky 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: PubMed 40924385Jeon 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 publication: PubMed 41726564Li 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yavuz Selim Pata, Professor study director
Yeditepe University Hospital
Banu Erkal, Resident principal investigator
Yeditepe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exosomes derived from human umbilical cord mesenchymal stem cells and Mesenchymal Stem Cells (MSC) in people with Sjogren Syndrome and Xerostomia, run by Banu Erkal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Banu Erkal, MD (+905319867061, banurkl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07838454, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.