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:
The treatment itself with either stem cells or a placebo (sterile saline).
Multiple saliva tests to measure saliva production.
Saliva samples stored for later analysis to see if the saliva's ability to protect
teeth and aid digestion changes after stem cell treatment.
A blood test to examine the immune system's response to the stem cell treatment.
A clinical examination to see if the stem cell treatment affects Sjögren's Syndrome
symptoms elsewhere in the body.
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.