NCT07290946

Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Christian von Buchwald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Xerostomia Due to Hyposecretion of Salivary Gland
• Xerostomia Due to Radiotherapy
• Sjögren´s Syndrome

Interventions

Type	Name	Description
DRUG	ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS	Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
DRUG	Placebo	Sterile isotonic saline water

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-06-01
• Completion: 2028-12-01
• First posted: 2025-12-18
• Last updated: 2025-12-18