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Stem cells offer hope for cancer survivors with chronic dry mouth

NCT ID NCT07431645

Disease control Sponsor: Institute of Oncology Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested whether stem cells from donated umbilical cord tissue could help people with chronic dry mouth after radiation for head and neck cancer. Ten adults received a single injection of these stem cells and were monitored for safety and any improvement in saliva production. The goal is to see if this approach is safe enough to study further as a possible treatment for radiation damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
umbilical cord-derived mesenchymal stromal cells (stem cells)
What this could lead to
If this works, it could point toward a regenerative treatment for radiation-induced dry mouth, improving quality of life for head and neck cancer survivors.
What could go wrong
This is a very early, small pilot study with only 10 participants and no control group. The treatment may not prove effective or safe in larger trials, and stem cell therapies carry unknown long-term risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms Xerostomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer Radiation induced xerostomia

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

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