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Intraglandular treatment with adipose derived mesenchymal stem cells in patients with xerostomia due to Sjögrens syndrome (ASSIX)
EU CTIS ID: 2024-516715-25-00
What this study is testing
The primary objective of this study is to investigate the effectiveness of injection of adipose derived mesenchymal stem cells in the submandibular glands compared to injection of placebo on the salivary gland function measured as the change in the unstimulated whole saliva flow rate (UFR) from baseline to 4 months after treatment in patients with orimary Sjögren Syndrome related xerostomia.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 for pSS
- • Age above 18 years
- • Presence of xerostomia
- • UFR of minimum 0.05 ml/min and maximum 3.0 ml/min
- • Informed consent
You likely can't join if
- • Currently receiving xerogenic medications such as hypertensive medications, anticholinergic medication, tricyclic antidepressants, and opioids
- • Have any other diseases of the salivary glands, e.g. radiation-induced xerostomia
- • Previous had submandibular gland surgery
- • Previous had treatment with any type of stem cells in the saliva glands
- • Are pregnant or have a planned pregnancy within the four months study period
- • Are 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 pSS
- • Age above 18 years
- • Presence of xerostomia
- • UFR of minimum 0.05 ml/min and maximum 3.0 ml/min
- • Informed consent
- • Currently receiving xerogenic medications such as hypertensive medications, anticholinergic medication, tricyclic antidepressants, and opioids
- • Have any other diseases of the salivary glands, e.g. radiation-induced xerostomia
- • Previous had submandibular gland surgery
- • Previous had treatment with any type of stem cells in the saliva glands
- • Are pregnant or have a planned pregnancy within the four months study period
- • Are breastfeeding
- • Have been smoking within the previous 6 months from screening visit
- • Have a current alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines)
- • Have any other disease/condition judged by the investigator to be grounds for exclusion
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.