NCT06805448
Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
Recruiting · Phase 1, Phase 2 · Rigshospitalet, Denmark · registry updated 2025-02-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Living with dry mouth significantly impacts daily life, causing constant discomfort. It makes it harder to talk, eat solid food (increasing the risk of malnutrition), swallow, and sleep well. It also raises the risk of tooth decay. One common cause of dry mouth is Sjögren's Syndrome. Sjögren's Syndrome is a common chronic autoimmune disease. In this disease, the immune system attacks the body's own saliva glands, reducing saliva production and leading to severe dry mouth and its associated symptoms. Current treatments for dry mouth are temporary and only last a short time (from a few minutes to a few hours). Therefore, new treatment options are needed. Research has shown that mesenchymal stem cells can be used to treat dry mouth with promising results. These stem cells can be injected into a vein or directly into the saliva glands. Although the exact mechanism is not fully understood, studies suggest that stem cells can positively affect the immune system, reduce inflammation, regenerate tissue, and reverse scarring. This research group has been studying stem cell treatment for dry mouth for over 10 years and is internationally recognized....
Inclusion
- Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria for primary SjD (2)
- Age equal or above 18 years
- Persistent xerostomia for at least 3 months
- Unstimulated whole saliva flow rate (UWS) of minimum 0.05 ml/min and maximum 3.0 ml/min
- Capable and willing to receive proper information and to give written informed consent.
Exclusion
- Current intake of xerogenic medications such as anticholinergics, tricyclic antidepressants, opioids, and certain antihypertensive agents (23)
- Presence of any other diseases of the salivary glands, e.g. xerostomia due to radiation
- Previous submandibular gland surgery
- Previous treatment with any type of stem cells in the salivary glands
- Pregnancy or planned pregnancy within the 12 months study period
- Breastfeeding