Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation-Induced Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Mesenchymal Stromal Cells (MSC) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic MSC Treatment for Radiation-Induced Xerostomia
- description
- 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.
- interventionNames
- Biological: Allogeneic Mesenchymal Stromal Cells (MSC)
Primary outcomes (1)
- measure
- Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
- timeFrame
- From intervention through 4 months after the intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available