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What you need to know about the next skin graft trials

What you need to know about the next skin graft trials

We're pleased to confirm that researcher Michele De Luca and his team, who pioneered the skin grafting procedure and successfully reconstructed a fully functional outer skin – or epidermis – for a child suffering from Junctional EB (Epidermolysis Bullosa) have received funding to carry out further trials of the technique.

The Hologene Trial has been designed to test the safety and effectiveness of the skin grafting technique in people with EB: a) Hologene 7 study focuses on patients living with Dystrophic EB and b) Hologene 5 study is aimed at those suffering from Junctional EB. The Hologene Trial is taking place in Austria and both aim to recruit up to 12 patients who meet the specific medical criteria.

What does this mean?

Researchers will take a small sample of skin cells from each participant, which will then be genetically corrected in the lab and grown into sheets of skin to be grafted back on to selected areas of the participant’s body.

That’s great – I’m ready to take part. What do I do now?

Even if you have the kind of EB that’s being investigated in the Trial, you may not be eligible to take part. All clinical trials have complex selection and eligibility criteria that must be met before you can take part.

To take part in any type of clinical trial, the first person you must speak to is your own specialist EB doctor. They can talk to you about trials that may be taking place and the processes you’ll need to go through to find out if it’s possible for you to take part.

Your medical suitability to take part in a trial must be assessed and confirmed by a doctor before you can take part. Once it has been confirmed that you are eligible, you must be registered with the medical team carrying out the research before you can take part.

Taking part in any clinical trial is a potentially risky process. Know the risks and potential benefits of clinical studies and talk to your specialist EB doctor before participating.

If you’re not already registered, ask your GP to refer you to one of the specialist EB teams.

Contact your specialist EB clinical team. 

Is this a cure for EB?

No. If successful, this trial could lead to further research that could potentially lead to a more effective treatment for healing some wounds in some types of EB. It is not a cure for EB.

Will this work for everyone with EB?

Probably not. If successful, this trial could potentially lead to a more effective treatment for healing some wounds in some types of EB, but it’s not guaranteed to work for everyone with EB.

When is this available for me?

Clinical trials aim to make sure that a treatment is safe and works as planned in a suitable number of patients. Once this information can be confirmed, treatments are then made available.

Clinical trials can take years and there are currently no plans to make this widely available as a potential treatment for EB. When new treatments do become available, you’ll be the first to know.

What is happening here in the UK?

DEBRA is funding researchers across the UK (and abroad) focusing on worldwide collaboration for quality of life enhancements and, treatments and cures for EB. Find out more about UK funded research projects here.

I or someone I know wants to be involved in a clinical trial. How do I sign up?

You must speak to your own specialist EB doctor before you take part in any trial. They can talk to you about trials that may be taking place and the processes you’ll need to go through to find out if it’s possible for you to take part.

Applying and taking part can be a lengthy and time consuming process and requirements vary from trial to trial.

Where can I find out more about other EB research opportunities?

Please join the DEBRA International Research Involvement Network on Facebook or get in touch with the DEBRA UK Research Team on research@debra.org.uk.

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