NCT07431645CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 18 Feb 2026
- Start date
- 1 Apr 2023
- Primary completion date
- 10 Oct 2025
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Head and neck cancer
- NCT number
- NCT07431645
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 1 Apr 2023 to the primary completion date, 10 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Any condition that, in the investigator's opinion, would interfere with participation or evaluation of outcomes
Other
- Contraindication to the planned intervention (MSC administration)
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.