Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells

This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Xerostomia is a frequent late adverse effect of radiotherapy and can significantly impair oral function and quality of life. Participants receive a single administration of allogeneic MSCs as the study intervention and are followed for clinical outcomes. The study evaluates safety, salivary gland function, subjective xerostomia symptoms, and imaging-based changes in salivary gland tissue. The results of this pilot study may support the development of regenerative treatment strategies for radiation-induced salivary gland damage.

NCT Number	NCT07431645
Lead Sponsor	Institute of Oncology Ljubljana
Conditions	Radiation-Induced Xerostomia, Head and Neck Cancer
Enrollment	10 participants
Start Date	2023-04-01
Primary Completion	2025-10-10 (estimated)
Study Completion	2025-10-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-03