AuthorisedTherapeutic exploratory (Phase II)Interventional

Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

This study is for people who have a very dry mouth, called xerostomia, because of radiotherapy for head and neck cancer. Researchers are testing a treatment that uses special cells called Mesenchymal Stem Cells, taken from fat, to see if they can help the body make more saliva. The main goal is to measure how much saliva people produce after eight months of treatment. This is important because a dry mouth can cause many problems like difficulty eating, speaking, and an increased risk of dental issues. The study is in an early stage (Phase II) to see if this treatment is safe and shows promise.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rigshospitalet

Enrolment target

100

Start

08 Sep 2025

Xerostomia due to readiotherapy for a head & neck cancer

What is this study about?

This research study is looking into a new way to treat a common and often difficult problem called xerostomia, which is a very dry mouth. This condition often affects people who have had radiotherapy for head and neck cancer. Radiotherapy is a powerful treatment, but it can unfortunately damage the glands that make saliva, leading to a persistently dry mouth.

The study is exploring a treatment that uses special cells called Mesenchymal Stem Cells. These cells are taken from fat tissue in the body. The idea is that these cells can help repair the damaged glands and encourage them to produce more saliva. The researchers will be giving these cells, known as ADRC001, to participants and comparing them to a simple saltwater solution (called sterile isotonic saline water) to see if the cell treatment makes a difference.

The main thing the study will measure is how much saliva people produce when they haven’t been stimulated (meaning, without eating or chewing). This is a simple but important way to see if the treatment is working, as producing more natural saliva can greatly improve comfort and health for people with a dry mouth.

Key takeaways

Study for dry mouth (xerostomia) after head and neck cancer radiotherapy.
Tests a cell therapy from fat to increase saliva production.
Main measurement is how much saliva is naturally produced.
Participation lasts 8 months with check-ups at 4 and 8 months.
It's an early-stage study (Phase II) to see if the treatment shows promise.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate. The key requirement is that you have been diagnosed with a dry mouth (xerostomia) specifically because of radiotherapy you received for head and neck cancer.

The research team will carry out further checks to make sure your overall health and specific medical history make you a suitable candidate for the study, ensuring your safety throughout. They will explain these in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a dry mouth (xerostomia)?
Was your dry mouth caused by radiotherapy for head and neck cancer?
Are you able to attend appointments over an 8-month period?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive either the new cell therapy or a saltwater solution. You won't know which one you are getting at the time, as this helps make sure the results are fair. The main aim is to see how your saliva production changes over 8 months.

You will have check-ups and measurements taken at the beginning of the study, then again after 4 months, and finally at 8 months. During these visits, doctors will measure how much saliva you produce without any stimulation to see if the treatment is making a difference.

The total participation in the study, including all treatments and follow-up assessments, will last for 8 months. The research team will explain all the appointments and what each involves in detail before you decide to take part.

Potential risks and benefits

Taking part in this study could potentially help improve your dry mouth symptoms, but it's important to remember this is an early-stage study, and there's no guarantee the treatment will work for everyone. As with any medical procedure, there might be some risks, such as discomfort at the injection site or other side effects. The researchers will closely monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is 'xerostomia'?

It's the medical word for a persistent, very dry mouth, often caused by certain medical treatments.

What are Mesenchymal Stem Cells?

These are special cells found in your body, like in fat, that can help with repair. In this study, they're being tested to help produce more saliva.

Will I know if I'm getting the treatment or the saltwater?

No, you won't know at the time. This is standard in studies to make sure the results are unbiased and reliable.

How long will I be involved in the study?

Your involvement in the study, including all treatments and check-ups, will last for 8 months.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any point, and your decision won't affect your ongoing medical care.