Treatment for dry mouth using stem cells in Sjögren's Syndrome patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Joachim Hansen, M.D, PhD-fellow
• Email: joachim.hansen.01@regionh.dk
• Phone: +4523312552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.