Clinical trial for Sjorgren's Syndrome
Official title Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
ClinicalTrials.gov ID: NCT06805448
What this study is testing
What is MSC?
MSC is an investigational medicine, given as an once-daily, being studied as a potential treatment for sjorgren's syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients diagnosed with SS according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) classification criteria...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- Tobacco smoking within the previous 6 months from screening visit
- Have a current alcohol abuse (consumption must not exceed 10 units per week (Danish National board health alcohol guidelines (24))
- Any other disease/condition judged by the investigator to be grounds for exclusion
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.