AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Scar Remodeling after Burn Injury using Adipose-derived Allogeneic Stem Cells (ScarASC)

This early-stage research is exploring a new treatment for thick, often uncomfortable scars called hypertrophic scars, which can appear after a burn injury. The study is using special cells, taken from fat, to see if they can help these scars heal better and become less noticeable. This treatment involves using cells grown in a lab, combined with a special liquid. Researchers will carefully observe how patients' scars change, using a special scoring system based on what patients and observers notice. They will also use advanced techniques like 3D photography and ultrasound to measure scar size and thickness, and look at changes in the scar tissue itself at a microscopic level. A major part of this study is to ensure the treatment is safe, by closely monitoring for any unexpected side effects.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Copenhagen University Hospital

Enrolment target

Start

11 Apr 2025

Hypertrophic scarring.

What is this study about?

When you have a burn, your body sometimes over-heals, leading to scars that are thick, raised, and often itchy or painful. These are called hypertrophic scars. This clinical trial is investigating a new and innovative way to try and improve these scars using something called "adipose-derived allogeneic stem cells." Put simply, these are special healing cells that come from fat tissue, and "allogeneic" means they come from a donor, not from the patient themselves. The idea is that these cells might help the scar tissue to remodel and become flatter, softer, and less noticeable.

The researchers are at an early stage, which means they are primarily checking if this new treatment is safe for people to use. They will also be looking to see if there are any early signs that it helps reduce the thickness and improve the appearance and feel of these burn scars. They will compare a group receiving the active cells with a group receiving a neutral liquid, which helps ensure any changes observed are due to the cells themselves.

To see if the treatment works, doctors will be using a detailed assessment called the Danish Patient and Observer Scar Assessment Scale. This scale looks at how the scar feels and looks, both from your point of view as a patient and from the doctor's observation. They'll also use advanced tools like special cameras and ultrasound scans to measure the scar's size, thickness, and even look at the tiny fibres inside the scar to see if they are changing. This comprehensive approach helps them get a very clear picture of any improvements or changes.

Key takeaways

This study is testing a new treatment for thick burn scars (hypertrophic scars).
It uses special healing cells from fat, called adipose-derived stem cells.
The main goals are to check treatment safety and see if scars improve.
Participation involves regular visits and careful scar assessments.
It's an early-stage study, so the treatment is not yet proven standard care.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet the other requirements. The study is open to both men and women.

Crucially, you must have hypertrophic scars that developed after a burn injury. These are the thick, raised scars that the study aims to treat. The researchers will have specific criteria for how long ago your burn occurred and what your scars look like to ensure you are a good fit for the study.

Because this is a medical study, there will likely be other health checks and requirements to make sure it's safe for you to participate. For example, they might check your general health, if you have any other medical conditions, or if you are taking certain medications. These details would be explained in full by the study team.

Quick self-check

Are you 18 years old or older?
Do you have thick, raised scars (hypertrophic scars)?
Did these scars develop specifically after a burn injury?
Are you able to attend regular follow-up appointments?

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

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to confirm you meet all the eligibility criteria. This would involve medical check-ups and discussions about your health and scars. If you are eligible, you would likely receive the study treatment, which involves the special cells. This would be done according to a specific schedule outlined by the medical team.

You would then have regular follow-up visits with the study team. These visits are very important for monitoring your progress and ensuring your safety. During these visits, doctors would assess your scars using the special scales, take measurements with cameras and ultrasound, and might take small tissue samples (punch biopsies) to look at changes in the scar at a microscopic level. They would also ask about any side effects or changes you experience.

The study would involve a commitment to attend all scheduled appointments. The total duration of your participation would be clearly explained by the study team, from the initial screening to the final follow-up, ensuring they can track the long-term effects of the treatment and gather all necessary information.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of this study is that you might be among the first to receive a new treatment that could improve your hypertrophic burn scars, making them softer, flatter, and less noticeable. However, as with any new treatment, there are potential risks, such as side effects from the cells or the procedures involved, which could include infection, irritation, or an unexpected reaction. The study team will carefully monitor you for any such events. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Denmark

Common questions

What are hypertrophic scars?

These are thick, raised scars that often occur after injuries like burns. They can be itchy, painful, and restrict movement.

What are 'adipose-derived stem cells'?

These are special healing cells found in your body's fat. In this study, they come from a donor and are being tested to help scars improve.

Is this a new treatment?

Yes, this is an early-stage study (Phase I/II) meaning researchers are testing a new approach. It's not yet a standard treatment.

Will I definitely get the active treatment?

Some participants will receive the active treatment (the stem cells), while others may receive a neutral liquid for comparison. This is common in trials to see if the new treatment works.

Who can take part?

Adults aged 18 and over, of any sex, who have hypertrophic scars specifically from a burn injury.