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

NCT07431645 | Completed Phase 1

• 2 other identifiers: OI-XEROSTOMIA-MSC-2023ERID-KSOPR-0026/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Xerostomia; Head and Neck Cancer

Keywords

Xerostomia; Radiotherapy; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  From intervention through 4 months after the intervention

Study Arms (1)

Allogeneic MSC Treatment for Radiation-Induced Xerostomia

EXPERIMENTAL

Participants with radiation-induced xerostomia following radiotherapy for head and neck cancer receive a single administration of allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue. The intervention is performed according to the study protocol, and participants are prospectively followed to assess safety and preliminary efficacy, including salivary gland function, salivary quality, imaging findings, and patient-reported outcomes related to xerostomia.

Biological: Allogeneic Mesenchymal Stromal Cells (MSC)

Interventions

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.

Also known as: Umbilical Cord-Derived MSC, Allogeneic UC-MSC

Allogeneic MSC Treatment for Radiation-Induced Xerostomia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2023
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)