Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

First time in human clinical test using a personalized tissue-engineered blood vessel to treat chronical illness in a vein.

This is a very early clinical trial, often called a Phase 1 study, where doctors check the safety of a new treatment for the first time in people. The study is looking at a new way to treat a common long-term leg vein condition called chronic venous insufficiency, which can cause discomfort, swelling, and skin changes. Researchers are using a specially made blood vessel, grown in a lab using the patient's own cells, to see if it can help fix damaged veins and improve the condition. This treatment is personalised, meaning it's created uniquely for each patient. The main goal at this stage is to make sure the new treatment is safe to use in humans.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

VeriGraft AB

Enrolment target

Start

23 Dec 2024

Chronic venous insufficiency

What is this study about?

This study is about a new and exciting way to treat a condition called chronic venous insufficiency. This is a long-term problem where the veins in your legs, which are responsible for returning blood to your heart, don't work as well as they should. This can lead to symptoms like aching, swelling, heaviness, and even skin changes in the legs. Current treatments often manage symptoms, but this study is looking at a way to potentially fix the underlying problem.

The new treatment involves creating a 'personalized tissue-engineered blood vessel'. This means scientists will grow a new blood vessel in a lab, specifically designed for each patient, possibly using their own cells. The idea is to replace or repair the damaged part of the vein with this new, healthy vessel.

Because this is the very first time this specific type of treatment is being tested in humans, it's called a Phase 1 study. The main purpose of this initial phase is to carefully check if the treatment is safe for people and how the body reacts to it. Researchers will also learn about the right dose and how to best give the treatment, rather than focusing on how well it works at this early stage.

Key takeaways

This is a first-time-in-humans (Phase 1) study for a new treatment.
It aims to treat long-term leg vein problems (chronic venous insufficiency).
The treatment involves a specially grown, personalised blood vessel.
The main goal is to check for safety, not how well it works.
Participation would involve surgery and regular follow-up appointments.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit mentioned.

This study is open to both men and women. The specific details of your health condition will be very important in determining if you can take part.

Because this is a study for chronic venous insufficiency, you would need to have been diagnosed with this condition. The study will have more detailed rules about other health conditions, medications you might be taking, and past treatments you've had. These detailed rules help make sure the study is safe for everyone involved and that the results are clear.

Quick self-check

Are you 18 years old or older?
Do you have chronic venous insufficiency?
Are you able to attend regular follow-up appointments?
Do you understand this is a very early stage study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several visits to the study centre, likely including a screening visit to see if you meet all the requirements. If eligible, you would receive the investigational treatment, which involves the new blood vessel being implanted. This would likely require a hospital stay.

After the treatment, you would have regular follow-up appointments over an extended period. These visits would involve various assessments, such as physical examinations, blood tests, and scans, to monitor your health, check for any side effects, and see how the new blood vessel is doing. You would also need to report any new symptoms or concerns. The total duration of your participation, including follow-up, could extend for several months or even years.

Potential risks and benefits

Potential benefits of taking part in this trial include receiving a new, experimental treatment for chronic venous insufficiency that isn't yet available generally. You would also be contributing valuable information that could help others with the same condition in the future. However, as with any new medical procedure, there are potential risks. These could include side effects from the surgery, problems with the new blood vessel (like infection or not working as intended), or unexpected reactions to the new treatment. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is chronic venous insufficiency?

It's a long-term problem where leg veins don't properly return blood to the heart, leading to swelling, pain, and discomfort in the legs.

What does 'personalized' mean in this study?

It means the new blood vessel is specifically grown and designed in a lab for your body, potentially even using your own cells.

Is this treatment guaranteed to work?

No, as a very early (Phase 1) study, the main goal is to check for safety, not how well it works. There's no guarantee of benefit at this stage.

Will I have to stay in hospital?

Because the treatment involves a procedure to implant the new blood vessel, it is highly likely that you would need to stay in hospital.

Can I stop being part of the study once I've started?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.