A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells
Sponsor study identifier
Secondary identifiers
OTHER · Institute of Oncology Ljubljana (KSOPR)
interventional
10
1 country
1
Study Start
April 1, 2023
Actual (reported)Primary Completion
October 10, 2025
Actual (reported)Study Completion
October 10, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2023
Actual (reported)October 10, 2025
Actual (reported)October 10, 2025
Actual (reported)February 18, 2026
Actual (reported)February 24, 2026
Actual (reported)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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
10 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2026
First Posted
February 24, 2026
Study Start
April 1, 2023
Contact the study team to confirm eligibility.
Primary Completion
October 10, 2025
Actual (reported)Study Completion
October 10, 2025
Actual (reported)Last Updated
March 3, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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