A two-part study: open label, dose escalation phase aimed to evaluate the safety and tolerability of two different doses of allogeneic fibroblasts for the treatment of chronic refractory wounds and identifying the best dose for subsequent cohort expansion phase aimed to assess efficacy and confirm safety and tolerability
This study is investigating a new treatment, called FB-Plus, for people with chronic wounds that have not healed with standard care. These are often called 'refractory wounds'. The study has two main parts. The first part aims to find out if two different doses of FB-Plus are safe and how well people tolerate them. This helps researchers work out the best dose to use. The second part will then look at how effective this best dose is at helping wounds heal, while also keeping an eye on safety. This is an early-stage study, meaning it's one of the first times this treatment is being given to people.
At a glance
What is this study about?
Imagine you have a cut or sore that just won't heal, even after trying different treatments. This can be really frustrating and sometimes painful. These difficult-to-heal sores are what doctors call 'chronic refractory wounds'. This study is looking into a new way to help these wounds close up and get better. The treatment being tested is called FB-Plus. It uses special cells called fibroblasts, which are important for healing our skin.
The study is happening in two main stages. The first stage is like a careful first step: it's focused on understanding if FB-Plus is safe for people and if any side effects happen. Researchers will try out two different amounts (doses) of FB-Plus to see which one is tolerated best and causes the fewest problems. Finding the right dose is really important before moving forward.
Once they've found the best and safest dose, the study moves to its second stage. Here, the focus shifts to whether FB-Plus actually helps wounds heal. They will be measuring how much the wounds shrink, if they close completely, and if they become less painful. They'll also continue to monitor for any side effects to make sure the treatment remains safe.
Key takeaways
- This study tests a new cell-based treatment (FB-Plus) for chronic, hard-to-heal wounds.
- It aims to find a safe dose and then see how well it helps wounds heal.
- It's an early-stage study, meaning it's new and still being widely tested.
- Participation involves regular clinic visits for treatment, wound checks, and health monitoring.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Because this study is about a specific type of wound, other factors, such as the type of wound you have, how long you've had it, and your general health, will also be important. The study team will check these details carefully to make sure the study treatment is suitable and safe for you.
It's important to remember that not everyone with a chronic wound will be able to join. The researchers have strict rules to make sure the study is as safe as possible and that they can properly understand the effects of the treatment.
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 chronic wound that hasn't healed with other treatments?
- Are you able to attend regular clinic appointments?
- Are you willing to have medical tests like blood samples and ECGs?
What does participation involve?
Taking part in this study would involve regular visits to the clinic so the doctors can give you the FB-Plus treatment and keep a close eye on your wound. They will carefully examine your wound, taking measurements of its size and checking how it's healing. You might also be asked to complete questionnaires about your pain and how you're feeling overall.
Doctors will perform standard check-ups, such as measuring your blood pressure and heart rate, and taking blood and urine samples. These tests help ensure you are staying healthy throughout the study. The exact number of visits and the total length of time you'd be involved will be explained in detail by the study team. You'll likely have follow-up appointments even after the main treatment period to see how your wound continues to heal.
Potential risks and benefits
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Common questions
What is a 'chronic refractory wound'?
It's a wound, like an ulcer or persistent sore, that hasn't healed despite regular medical care over a long period.
What is FB-Plus?
FB-Plus is an experimental treatment using special cells called fibroblasts, which are involved in skin repair and healing.
Is this a new treatment?
Yes, this is one of the first times FB-Plus is being tested in humans, making it an early-stage study.
Will I know if I'm getting the active treatment?
This study is 'open label', which means both you and the study team will know you are receiving FB-Plus.
What kind of tests will I have during the study?
You'll have regular wound checks, blood tests, urine tests, physical exams, and heart tests (ECGs) to monitor your health and how the wound is responding.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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