A multi-centre, randomised, single-blind Phase I/IIa study to evaluate the safety, tolerability and efficacy of a single topical dose of allogeneic integrin α10β1-selected mesenchymal stem cells (XSTEM-VLU) in patients with difficult-to-heal venous leg ulcers
This research study is about finding better ways to treat venous leg ulcers that haven't healed with usual care. Doctors are testing a new treatment called XSTEM-VLU, which is a special patch with unique cells designed to help wounds heal. They want to see if this patch is safe for people to use and if it can help their ulcers get better. This study is in its early stages (Phase I/IIa), meaning it's one of the first times this treatment is being used in people. It will involve different hospitals working together. Participants will get an active treatment or a comparison treatment to fairly test how well it works. The goal is to find new and more effective ways to help people with difficult-to-heal leg ulcers.
At a glance
What is this study about?
Imagine you have a leg ulcer that just won’t heal, even after trying different treatments. This can be really frustrating and painful. This study is looking into a new way to help these kinds of ulcers get better. Researchers are testing a special patch medicine called XSTEM-VLU. This patch contains unique types of cells that are thought to help speed up the healing process of difficult wounds.
The main idea behind this study is to see two key things: first, is this new patch safe for people to use? And second, does it actually help the ulcers heal or get smaller? Because this is an early-stage study, it's designed to gather a lot of information about how the treatment works in people for the first time. They want to understand if it causes any problems and how effective it might be.
To make sure they get good information, some people will get the special patch, while others might get a different treatment or a dummy treatment that looks the same but doesn't have the active cells. This allows the doctors to compare the results fairly. The hope is that if this new treatment works well, it could become a helpful option for many people who suffer from long-lasting venous leg ulcers.
Key takeaways
- Tests a new patch to heal stubborn leg ulcers.
- Aims to check safety and if it helps ulcers improve.
- For adults (18+) with leg ulcers that haven't healed easily.
- Involves a single patch application and regular check-ups.
- Participation is voluntary, you can leave anytime.
Who may be eligible?
This study is looking for adults aged 18 or older who have venous leg ulcers that have been difficult to heal. This means your ulcer hasn't gotten better with the usual treatments over a period of time.
Both men and women can take part in this study. The doctors will need to check your medical history and current health to make sure this study is right for you and safe. There might be some specific health conditions that would prevent you from joining, but the study team will discuss all of this with you in detail.
It's important that you understand what's involved and are willing to attend appointments and follow the study instructions if you decide to participate.
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?
- Do you have a leg ulcer?
- Has your leg ulcer been hard to heal with usual treatments?
- Are you able to attend regular appointments for check-ups?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to make sure you meet all the requirements. If you do, you would then be randomly assigned to receive either the new XSTEM-VLU patch or a comparison treatment. This means you wouldn't get to choose which one you receive.
The new treatment is a single application of a special patch directly onto your leg ulcer. You would then have regular check-ups with the study team at the hospital or clinic. These visits would involve looking at how your ulcer is healing, taking measurements, and asking about your general health and any side effects you might be experiencing. These frequent visits would continue for several weeks or months, and there will also be follow-up calls or visits to see how you're doing after the main treatment period. The total duration of your participation would be explained to you by the study team, but it's likely to involve several months of monitoring.
Potential risks and benefits
Locations (1)
- —UnverifiedSweden
Common questions
What is a 'venous leg ulcer'?
It's a skin sore on your leg, usually around the ankle, that develops when blood doesn't flow properly in your leg veins, causing pressure and damage to the skin.
What does 'difficult-to-heal' mean?
It means the ulcer has been present for a long time, usually several weeks or months, and hasn't shown much improvement despite regular medical treatment.
What are 'mesenchymal stem cells'?
These are special cells found in the body that have the ability to develop into different cell types and can help repair damaged tissues and reduce inflammation.
Will I know if I'm getting the active treatment or not?
No, this is a 'single-blind' study, meaning you won't know if you're getting the active patch or the comparison treatment. This helps us get fair results.
Do I have to pay to be in the study?
No, all study-related treatments and visits are provided at no cost to you. You may be reimbursed for travel expenses related to your study visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.