Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease

Launched by RIGSHOSPITALET, DENMARK · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for people suffering from dry mouth, known as xerostomia, caused by Sjögren's Syndrome. Sjögren's Syndrome is a condition where the immune system attacks the saliva glands, leading to reduced saliva production and significant discomfort. Current treatments for dry mouth are temporary, so this study aims to see if injecting stem cells from healthy donors’ fat tissue directly into the saliva glands can improve saliva production and reduce dry mouth symptoms.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of Sjögren's Syndrome with persistent dry mouth for at least three months. Participants will receive either the stem cell treatment or a placebo (a harmless saline solution) through a quick injection guided by ultrasound. Throughout the study, their saliva production and any changes in symptoms will be closely monitored, and they will be asked about any side effects. The research is being conducted safely and ethically, with oversight from health authorities.

Gender

ALL

Eligibility 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