Head and Neck Cancer, Radiation-Induced Xerostomia
Conditions
Keywords
Xerostomia, Radiotherapy, Head and Neck Cancer
Brief 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.
Interventions
BIOLOGICALAllogeneic 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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with radiation-induced xerostomia receive allogeneic umbilical cord-derived mesenchymal stromal cells (MSC). Safety and preliminary efficacy outcomes are assessed during follow-up after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia | 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. |
Countries
Slovenia
Outcome results
None listed