A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
This study is about keeping an eye on the long-term safety of a past treatment for macular degenerative disease. This treatment involved putting special cells, called human embryonic stem cell-derived retinal pigment epithelial cells, into the eye. If you previously had this treatment as part of a trial run by the Astellas Institute for Regenerative Medicine (AIRM), this study is for you. Researchers want to make sure there are no unexpected problems that show up many years later, specifically problems that might be linked to the treatment cells. They will contact you each year to ask questions about your health and any new symptoms you might have noticed. This helps them understand the long-term effects and safety of this kind of cell therapy.
At a glance
What is this study about?
This study is designed to carefully monitor the well-being of people who received a specific cell-based treatment for macular degenerative disease in previous research trials. The treatment involved using special cells, called human embryonic stem cell-derived retinal pigment epithelial cells, which were placed into the eye. These cells were hoped to help with the eye condition.
The main goal of this particular study is to check for any health issues or side effects that might appear a long time after the treatment, specifically more than five years later. Researchers want to find out if there are any problems that could be connected to these special cells. This long-term monitoring is a crucial part of understanding how safe and effective new treatments are over many years.
By carefully tracking the health of participants, the study helps medical professionals learn more about the lasting effects of this innovative cell therapy. This information is very important for future decisions about similar treatments and can help make sure future patients receive the safest and best care possible.
Key takeaways
- This study tracks the long-term safety of a past macular disease cell therapy.
- It's for people who received specific cell treatment in an earlier AIRM trial.
- Participation involves annual health questionnaires.
- For UK participants, this monitoring is lifelong.
- The goal is to identify any late-appearing side effects of the cell treatment.
- No new treatments or procedures are part of this study.
Who may be eligible?
To be part of this study, you must have previously received a specific cell treatment for macular degenerative disease. This treatment would have been given as part of a clinical trial sponsored by the Astellas Institute for Regenerative Medicine (AIRM).
Essentially, if you were a participant in one of those earlier trials where you had human embryonic stem cell-derived retinal pigment epithelial cells transplanted into your eye for your macular condition, then you are likely eligible.
There are no other specific requirements to exclude you, as long as you are able to understand what the study involves and can give your consent to take part.
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.
- Did you previously receive a cell treatment for macular degenerative disease?
- Was this treatment part of a clinical trial?
- Was that trial sponsored by the Astellas Institute for Regenerative Medicine (AIRM)?
- Are you able to understand information and answer questions about your health?
- Are you 18 years old or older?
What does participation involve?
If you decide to take part in this study, your involvement will be quite straightforward. A team from the Patient Outreach Center (POC) will get in touch with you once a year. They will ask you to complete a questionnaire about your health and whether you've experienced any specific health issues since your treatment.
You can fill out this questionnaire online using a secure website, or a staff member from the POC can ask you the questions over the phone. If you experience any health problems that you think might be related to your past treatment, the study encourages you to contact the POC as soon as possible, rather than waiting for your annual questionnaire.
For participants in the United Kingdom, this monitoring will continue for the rest of your life. This includes periods from your original trial, a long-term follow-up trial, and then this permanent safety follow-up. There are no study visits, medications, or additional procedures involved beyond completing these annual check-ins.
Potential risks and benefits
Locations (2)
- Private PracticeVerified postcodeKansas City, United States
- Site GB44001Verified postcodeLondon, United Kingdom
Common questions
What is the main purpose of this study?
The study aims to check for any health problems that might appear many years after people received a specific cell treatment for macular disease in a past trial.
Who can take part in this study?
You can take part if you previously received the human embryonic stem cell treatment for macular disease in a clinical trial sponsored by Astellas Institute for Regenerative Medicine (AIRM).
What will I have to do if I join?
You will be contacted once a year to complete a questionnaire about your health over the phone or online. You should also report any new health issues to the study team as they happen.
How long will I be in this study?
For UK participants, this safety monitoring will continue for the rest of your life.
Do I have to take any new medicine or have more procedures?
No, this study only involves annual check-ins and questionnaires; there are no new medicines or medical procedures required.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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