Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.
The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
WHO Performance status 0-1
Presence of xerostomia daily
UWS of 0.05 mL/min to 0.5 ml/min
Any malignant cancer diagnosis excluding head and neck cancers
Xerogenic medications at inclusion
Penicillin or streptomycin allergy assessed by health personnel
Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
Christian von Buchwald
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution