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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06805448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • MSC
  • Saline Water (Control)
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Where

1 site
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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