drugset / Trial / NCT07290946

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

NCT07290946 ↗

Phase 2 Not yet recruiting 100 enrolled Christian von Buchwald
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-12
Primary completion
2027-06
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS Cell therapy — Other

Indications