Treatment for dry mouth using stem cells in Sjögren's Syndrome patients
Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögrens Disease
This study is testing whether injections of stem cells can help people with Sjögren's Syndrome who have dry mouth feel better and produce more saliva.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06805448 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of adipose-derived mesenchymal stem cells (MSCs) to treat xerostomia, or dry mouth, in patients suffering from Sjögren's Syndrome. The study aims to assess the safety and efficacy of intraglandular injections of MSCs compared to a saline control. Participants will be monitored for improvements in saliva production and overall quality of life. The trial is designed to provide a new, potentially long-lasting treatment option for a condition that currently has limited therapeutic options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Sjögren's Syndrome and experiencing persistent dry mouth.
Not a fit: Patients who have other diseases affecting the salivary glands or are currently taking medications that cause dry mouth may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with Sjögren's Syndrome by alleviating dry mouth symptoms.
How similar studies have performed: Previous studies have shown promising results using mesenchymal stem cells for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for primary SjD (2) 2. Age equal or above 18 years 3. Persistent xerostomia for at least 3 months 4. Unstimulated whole saliva flow rate (UWS) of minimum 0.05 ml/min and maximum 3.0 ml/min 5. Capable and willing to receive proper information and to give written informed consent. Exclusion Criteria: 1. Current intake of xerogenic medications such as anticholinergics, tricyclic antidepressants, opioids, and certain antihypertensive agents (23) 2. Presence of any other diseases of the salivary glands, e.g. xerostomia due to radiation 3. Previous submandibular gland surgery 4. Previous treatment with any type of stem cells in the salivary glands 5. Pregnancy or planned pregnancy within the 12 months study period 6. Breastfeeding 7. Tobacco smoking within the previous 6 months from screening visit 8. Have a current alcohol abuse (consumption must not exceed 10 units per week (Danish National board health alcohol guidelines (24)) 9. Any other disease/condition judged by the investigator to be grounds for exclusion
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Joachim Hansen, M.D, PhD-fellow
- Email: joachim.hansen.01@regionh.dk
- Phone: +4523312552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.