Phase IIB Clinical Trial to evaluate the efficacy and safety of Allogeneic Mesenchymal Stem Cell (MSC) eye injection treatment as therapy for Graft-versus-Host Disease (GvHD) refractory to conventional treatments
This study is testing a new treatment for severe dry eye, a very uncomfortable condition that can affect people with Graft-versus-Host Disease (GvHD). GvHD can happen after a bone marrow transplant when the new immune cells attack the patient's own body, including their eyes. When standard treatments don't help, this study investigates an eye injection containing special 'allogeneic mesenchymal stem cells' (eASC). Researchers want to find out if these cells are effective and safe in improving eye health, reducing dryness, increasing tear production, and making eyes feel better. The aim is to see if this injection can help those who haven't found relief with existing therapies.
At a glance
What is this study about?
This clinical trial is exploring a new treatment for people suffering from severe dry eye caused by a condition called Graft-versus-Host Disease (GvHD). GvHD can develop after a stem cell or bone marrow transplant when the transplanted cells see the patient's body as foreign and start to attack it, sometimes including the eyes. This can lead to very painful and persistent dry eye that doesn't get better with usual treatments.
The study is using a special type of cell called 'allogeneic mesenchymal stem cells' (or eASC for short). These are powerful cells that can help repair damaged tissues and reduce inflammation. In this trial, these cells are given through an injection into the eye. Researchers want to understand if these injections can improve the health of the eye surface, help the eye produce more tears, and reduce uncomfortable symptoms like redness and grittiness. They are also checking to see if these cells are safe to use.
The main goal is to see if these stem cell injections can make a real difference for people whose dry eye GvHD hasn't responded to other medicines. Scientists will measure improvements in various ways, such as how healthy the eye surface looks, how many tears are being made, and how much better patients feel according to questionnaires. This is a "Phase II" study, which means it's still in the early stages of testing, looking for promising results before potentially moving on to larger studies.
Key takeaways
- This study is for severe dry eye caused by GvHD, when other treatments haven't worked.
- It tests a new eye injection using special cells (eASC) to improve eye health.
- Researchers will check for reduced pain, better tear production, and a healthier eye surface.
- This is an early-stage study, aiming to see if the treatment is effective and safe.
- Participation involves eye checks, questionnaires, and possibly tear/blood samples.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The most important requirement is that you have been diagnosed with dry eye disease as a result of Graft-versus-Host Disease (GvHD).
Crucially, you would only be considered if your dry eye GvHD has not improved with other standard treatments. This study is specifically for those who haven't found relief from existing therapies and are looking for other options.
- Are you at least 18 years old?
- Have you been diagnosed with dry eye caused by GvHD?
- Have your dry eye symptoms not improved with other standard treatments?
- Are you able to attend regular appointments for eye checks?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive an eye injection containing the special eASC cells. Throughout the study, you would have several appointments where doctors would carefully check your eyes. They would use different tests, like special eye drops to see how healthy your eye surface is, and put a small strip of paper under your eyelid to measure tear production. You would also be asked to fill out questionnaires to describe how your eyes feel and how your symptoms have changed.
Researchers will also take small samples of your tears and blood to look for chemicals related to inflammation and to understand how the stem cells are working. The doctors will monitor you closely to make sure the treatment is safe and to track any changes in your eye health. You would have regular follow-up visits after the injection for a set period to see the long-term effects.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is Graft-versus-Host Disease (GvHD)?
GvHD can happen after a stem cell transplant, where the new immune cells mistakenly attack the patient's own body, sometimes causing eye problems.
What are eASC cells?
eASC are special 'stem cells' that are being tested in this study for their ability to help repair damaged tissues and reduce inflammation in the eyes.
How is the treatment given?
The treatment involves a special injection of these cells into your eye.
What will doctors be looking for?
They will check if the eye injection improves your eye's health, increases tear production, and reduces symptoms like dryness and redness.
Can I stop participating in the study?
Yes, you have the right to withdraw from the study at any time without needing to give a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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