SYMBOL CLINICAL : Treatment of severe ocular chemical burns by subconjunctival injection of allogeneic mesenchymal stem cells: a multicentre, single-arm, open-label phase II trial
This study, called SYMBOL CLINICAL, is investigating a new treatment for people who have severe chemical burns to their eye. The treatment involves injecting special cells, called mesenchymal stem cells, taken from healthy donors, around the burned eye. These cells are thought to help the eye heal. The main goal is to see if this treatment can prevent a serious complication called corneal perforation, which is when a hole forms on the clear front surface of the eye. Doctors will carefully check the eye to see how well it's healing and the effect of the treatment. This is an early-stage study to explore how safe and effective this new approach might be.
At a glance
What is this study about?
Imagine getting a bad chemical burn in your eye – it’s very painful and can seriously damage your sight. Doctors are always looking for better ways to help people in this situation. This study, called SYMBOL CLINICAL, is trying out a new treatment for severe chemical burns to the eye. It involves using special cells called mesenchymal stem cells.
These cells are taken from healthy donors and are known for their ability to help repair damaged tissues and reduce inflammation. In this study, these cells are carefully prepared and then injected near the burned eye. The main thing doctors want to find out is if this treatment can stop the clear front part of the eye (called the cornea) from developing a hole, which is a very serious problem that can affect your vision.
Researchers will also be closely watching other things, like how well your vision recovers, what the surface of your eye looks like, and if there are any side effects. This is a "Phase II" study, which means it's an early step to see if the treatment is safe and shows promise before being tested in a larger group of people.
Key takeaways
- This study explores a new cell-based treatment for severe chemical eye burns.
- The treatment uses special cells from donors to help the eye heal.
- Doctors want to see if it can prevent a hole from forming in the eye's surface.
- It's a Phase II study, meaning it's an early stage to check safety and effectiveness.
- Participants will receive the new treatment alongside standard eye care.
- Regular eye checks and assessments will be part of the study.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
The most important requirement is that you must have a severe chemical burn in your eye. The doctors will assess your eye to make sure it meets the specific criteria for the study, including ensuring there isn't already a hole in the surface of your eye when you join. Your medical team will check all these details carefully.
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?
- Have you recently experienced a severe chemical burn in one or both of your eyes?
- Have doctors confirmed that your eye does not currently have a hole or perforation?
- Are you able to attend regular appointments for eye check-ups and assessments?
What does participation involve?
If you decide to take part in this study, you will receive the experimental treatment, which involves an injection of special cells near your eye. You will also receive standard care, which may include various eye drops and other medications to help with pain and healing. Some of these medications might be given through a drip.
Throughout the study, you'll have regular check-ups with the doctors. These visits will involve several assessments, such as examining your eye under a special microscope (called a slit lamp, using a dye to check the eye's surface), checking your vision, and taking pictures of the front of your eye. Doctors will also collect information from your medical records to track your progress and look for any side effects. The total duration of your participation in the study, including all follow-up appointments, will be explained to you by the study team.
Potential risks and benefits
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Common questions
What are mesenchymal stem cells?
They are special cells from donors that can help other cells grow and repair damaged body parts, like a burned eye, and reduce swelling.
Will I still get my usual eye care?
Yes, you will receive the new treatment in addition to the standard care normally given for chemical eye burns.
How will doctors know if the treatment is working?
They will regularly check your eye for signs of healing, monitor your vision, and look for serious problems like a hole forming in your eye.
Is this treatment available to everyone?
No, it's an experimental treatment only available to people who meet specific criteria for this research study at the moment.
What's the main goal of this study?
The main goal is to see if the new cell treatment can stop a serious complication where a hole forms in the clear front part of your eye after a chemical burn.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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