NCT07431645

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

A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective pilot interventional clinical study designed to assess the safety and preliminary efficacy of treatment of radiation-induced xerostomia using allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Radiation-induced xerostomia is a common late complication in patients treated with radiotherapy for head and neck cancer and is associated with reduced salivary flow, impaired oral health, swallowing difficulties, and decreased quality of life. Allogeneic MSCs are characterized by strong immunomodulatory properties and regenerative potential. In this study, MSCs obtained from umbilical cord tissue are administered as a therapeutic intervention to evaluate their potential to improve salivary gland function and reduce symptoms of xerostomia. The primary objective of the study is to assess the safety of MSC administration, with follow-up monitoring for adverse events during a four-month period after the intervention. Secondary objectives include evaluation of preliminary efficacy of MSC therapy by assessing: subjective xerostomia symptoms and patient-reported outcomes, salivary flow and salivary quality parameters, radiological, scintigraphic, and morphological changes of salivary gland tissue following treatment. Participants undergo structured clinical evaluations and follow-up assessments according to the study protocol. The study aims to provide early evidence on feasibility and potential clinical benefit of MSC-based therapy for the treatment of radiation-induced xerostomia.

Conditions

• Radiation-Induced Xerostomia
• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Mesenchymal Stromal Cells (MSC)	Allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue are administered to participants with radiation-induced xerostomia following radiotherapy for head and neck cancer. The intervention is performed according to the study protocol to evaluate safety and preliminary efficacy. Participants are monitored for adverse events and changes in salivary gland function, saliva quality, imaging findings, and xerostomia-related symptoms during follow-up.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2026-02-24
• Last updated: 2026-03-03

Locations

1 site across 1 country: Slovenia