NCT06805448 Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
| NCT ID | NCT06805448 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Sjorgren's Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-01-21 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The group have conducted three studies where we injected stem cells into the saliva glands of patients with dry mouth due to radiation therapy for head or neck cancer. Results showed a 30%-50% increase in saliva production and a significant reduction in dry mouth symptoms. No studies have yet investigated injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome. One study did inject stem cells into tear glands with promising results. Therefore, this study aim to investigate injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome. For this study, mesenchymal stem cells harvested from the fat tissue of healthy adult donors is used. This type of stem cell is better at reversing scarring and forming new blood vessels. The procedure is quick and has few side effects, and donors benefit from the fat removal. The fat is typically taken from the abdominal area. Donors are tested for various diseases to ensure they are healthy. Previous studies have shown that the treatment is safe with only a few temporary side effects. The hypothesis is that injecting stem cells into the saliva glands of patients with dry mouth due to Sjögren's Syndrome will improve saliva production and reduce dry mouth symptoms. The study aims to determine if this treatment increases saliva production and reduces symptoms caused by dry mouth. To test these hypotheses, the study will include: 1. The treatment itself with either stem cells or a placebo (sterile saline). 2. Multiple saliva tests to measure saliva production. 3. Saliva samples stored for later analysis to see if the saliva's ability to protect teeth and aid digestion changes after stem cell treatment. 4. A blood test to examine the immune system's response to the stem cell treatment. 5. A clinical examination to see if the stem cell treatment affects Sjögren's Syndrome symptoms elsewhere in the body. 6. Questionnaires to assess participants' perceptions of changes in dry mouth symptoms after treatment. The treatment involves injecting either stem cells or a placebo into the two saliva glands near the jaw, guided by an ultrasound scan. The procedure takes 10 minutes. Although stem cell treatment has been shown to be safe, safety will be monitored in this study. At all three visits, participants will be asked about any side effects, which will be categorized as serious or mild, and as treatment-related or not. Follow-up and treatment plans will be made for any side effects. Participants will also always have direct access to the treating doctor. The study will be monitored by the Danish Medicines Agency and the GCP unit, which ensures that all rules and laws are followed.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06805448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sjorgren's Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06805448 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06805448 currently recruiting?
Yes, NCT06805448 is actively recruiting participants. Contact the research team at joachim.hansen.01@regionh.dk for enrollment information.
Where is the NCT06805448 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06805448 clinical trial?
NCT06805448 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 40 participants.