Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells (NCT07431645) | Clinical Trial Compass
CompletedPhase 1
Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells
Slovenia10 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Timeframe: From intervention through 4 months after the intervention