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Stem cells injected twice may finally quench cancer survivors' dry mouth

NCT ID NCT07290946

Disease control Sponsor: Christian von Buchwald 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether two doses of stem cells, given four months apart, can improve saliva production and reduce dry mouth in people who had radiation for head and neck cancer or have Sjögren's disease. One hundred participants will receive either stem cells or a placebo. The goal is to see if repeated treatment works better than a single dose.

What this could mean

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

Active substance
allogeneic adipose-derived mesenchymal stem cells
What this could lead to
If it works, this could offer a new treatment for chronic dry mouth, improving saliva production and quality of life for cancer survivors.
What could go wrong
This is a phase 2 trial with only 100 participants. Previous stem cell studies showed limited success in restoring normal saliva flow, and repeated treatments may not work better. Risks include infection or immune reaction.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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: 1. Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity 2. WHO Performance status 0-1 3. Presence of xerostomia daily 4. UWS of 0.05 mL/min to 0.5 ml/min 5. Age above 18 6. Informed consent 7. 0.5 year follow-up of the cancers in 1. with no recurrence Exclusion Criteria: 1. Any malignant cancer diagnosis excluding head and neck cancers 2. Xerogenic medications at inclusion 3. Penicillin or streptomycin allergy assessed by health personnel 4. Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis) 5. Previous submandibular surgery or biopsy 6. Pregnancy or planned pregnancy until 4 months after second treatment 7. Breastfeeding 8. Smoking within the last 6 months 9. Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms Sjogren syndrome Xerostomia

As listed by the trial registrant

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

Sjögren's syndrome Xerostomia due to hyposecretion of salivary gland Xerostomia due to radiotherapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.