AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

mRNA Therapy to restore lymphatic flow in secondary lymphedema

This research is looking into a new type of treatment called mRNA therapy for people with lymphedema. Lymphedema often causes swelling and discomfort, usually in the arms or legs, because the body's natural system for draining fluid (the lymphatic system) isn't working properly. This study is in its early stages (Phase I and II), meaning it's the first time this treatment is being given to people. The main goal is to see if the mRNA therapy is safe and if it can help improve how the lymphatic system works, potentially reducing swelling and improving symptoms for those affected by lymphedema. Researchers want to understand if this new approach can restore the body's ability to clear excess fluid more effectively.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

18 May 2026

Lymphedema

What is this study about?

Lymphedema is a long-term condition that causes swelling in parts of the body, most commonly the arms or legs. This happens when the lymphatic system – a network of vessels and nodes that carry a fluid called lymph – doesn't work as it should. This can lead to discomfort, heaviness, and sometimes infections.

This study is exploring a new and innovative treatment for lymphedema, using something called mRNA therapy. You might have heard of mRNA with some vaccines. In this study, the mRNA treatment is designed to try and help kickstart or improve the body's natural lymphatic system. The idea is to teach the body to produce specific proteins that can help repair or encourage the growth of new lymphatic vessels, which could then help drain away the excess fluid.

Because this is an early-stage study (called Phase I and Phase II), it's the first time this specific mRNA treatment is being used in humans. Researchers will be carefully checking to see if it's safe and if it has any positive effects on the lymphatic system and the symptoms of lymphedema. Finding new and effective ways to manage lymphedema is very important, as current treatments mostly focus on managing symptoms rather than addressing the underlying cause.

Key takeaways

This study is testing a new mRNA treatment for lymphedema.
It's an early-stage trial (Phase I/II) to check safety and effectiveness.
The treatment aims to help the body's lymphatic system work better.
Only women aged 18 and over with lymphedema are eligible.
Participation involves regular clinic visits, tests, and follow-up.

Who may be eligible?

To be considered for this study, you must be female and aged 18 years or older. There is no upper age limit, meaning women of all adult ages could potentially take part.

Beyond these basic requirements, the research team will have other specific health checks to make sure the study is right for you and safe. For example, they'll need to confirm that you have a confirmed diagnosis of lymphedema and that your overall health allows you to participate safely in a new treatment trial. They will ask about your current medications and other health conditions.

It's important to remember that not everyone who meets the initial age and sex criteria will be able to join the study. The doctors and nurses running the trial will carefully review everyone's medical history to determine if they are a good fit for this particular research.

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 female?
Are you 18 years old or older?
Have you been diagnosed with lymphedema?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for medical check-ups and to receive the new mRNA treatment. You would have various tests, such as blood tests, imaging scans to look at your lymphatic system, and measurements of your swelling, to see how the treatment is affecting you. The exact number of visits, tests, and the total length of time you'd be involved in the study would be explained in detail by the research team if you are eligible. There would also be follow-up appointments after the main treatment period to monitor your long-term health and the effects of the treatment.

Potential risks and benefits

Potential benefits of joining this study include being among the first to try a new treatment that might improve your lymphedema symptoms and the way your lymphatic system works. However, because this is a new treatment, there could be unknown risks or side effects that the researchers are not yet aware of. All known potential risks will be thoroughly explained to you, including things like reactions at the injection site or other general side effects. You are free 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
France

Common questions

What is mRNA therapy?

mRNA therapy uses a molecule called mRNA to give your body instructions to make certain proteins that can help repair or improve your lymphatic system.

Is this treatment a cure for lymphedema?

This is an early-stage study, so it's too soon to know if it can cure lymphedema. The aim is to see if it can improve symptoms and lymphatic function.

Will I know if I'm getting the actual treatment or a placebo?

The study design will be fully explained. Sometimes, in early trials, everyone receives the treatment, but in others, some might receive a comparison treatment or placebo. The doctors will tell you which applies here.

How long will the study last if I join?

The total duration of your participation, including treatment and follow-up, will be clearly explained by the study team, as it can vary depending on the particular trial design.

Will I have to pay to be part of the study?

No, you will not have to pay to participate in the study, and study-related treatments and tests will be provided free of charge. Travel costs may also be reimbursed; please ask the study team about this.