Exosome and Mesenchymal Stem Cell Treatment for Salivary Gland Dysfunction in Primary Sjögren Syndrome
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Banu Erkal, MD
- Telefonnummer: +905319867061
- E-post: banurkl@gmail.com
Studer Kontakt Backup
- Navn: Yavuz Selim Pata, Professor
- Telefonnummer: +905337602070
- E-post: yavuzpata@hotmail.com
Studiesteder
-
-
Kadikoy
-
Istanbul, Kadikoy, Tyrkia (Türkiye), 34718
- Yeditepe University Hospital
-
Ta kontakt med:
- Banu Erkal, MD
- Telefonnummer: +905319867061
- E-post: banurkl@gmail.com
-
Ta kontakt med:
- E-post: banurkl@gmail.com
-
Hovedetterforsker:
- Banu Erkal, MD
-
Hovedetterforsker:
- Yavuz Selim Pata, Professor
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
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. |
|
Eksperimentell: 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. |
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 komparator: 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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Salivary Flow Rate From Baseline to Month 6 Assessed by Sialoscintigraphy
Tidsramme: 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. |
Baseline to Month 6
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Xerostomia Inventory Score
Tidsramme: 3 months
|
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. |
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Yavuz Selim Pata, Professor, Yeditepe University Hospital
- Hovedetterforsker: Banu Erkal, Resident, Yeditepe University Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Muskel- og skjelettsykdommer
- Munnsykdommer
- Stomatognatiske sykdommer
- Leddgikt
- Leddsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Øyesykdommer
- Leddgikt, revmatoid
- Spyttkjertelsykdommer
- Syndromer med tørre øyne
- Tåreapparatsykdommer
- Hud- og bindevevssykdommer
- Sjøgrens syndrom
- Xerostomi
Andre studie-ID-numre
- SJGEXO2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared with other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .