Completed

NCT Number: NCT07431645

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.

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Key information

Conditions

Radiation-Induced Xerostomia Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older
History of radiotherapy for head and neck cancer
Presence of radiation-induced xerostomia
Completed oncological treatment
Ability to understand the study procedures and provide written informed consent

Exclusion criteria

Active malignant disease requiring ongoing oncological treatment
Acute infection or inflammation in the oral cavity or salivary glands
Severe systemic disease or condition that could influence study results
Contraindication to the planned intervention (MSC administration)
Pregnancy or breastfeeding
Any condition that, in the investigator's opinion, would interfere with participation or evaluation of outcomes

Treatment and study plan

Allogeneic Mesenchymal Stromal Cells (MSC)

Biological

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.

Other names: Umbilical Cord-Derived MSC, Allogeneic UC-MSC

Primary outcomes

Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia

Time frame: From intervention through 4 months after the intervention

Safety is assessed by the incidence, type, and severity of adverse events and serious adverse events following administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSC) in participants with radiation-induced xerostomia.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 24, 2026
Registry last updated: Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed