The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic
Timeframe: Up to 15 Years
Number of new diagnoses of an immune-mediated disorder
Timeframe: Up to 15 Years
Incidents of new cancer, irrespective of prior history
Timeframe: Up to 15 Years
Incidents of hESC-RPE cell proliferation
Timeframe: Up to 15 Years
Incidents of ectopic tissue (RPE or non-RPE) formation
Timeframe: Up to 15 Years
Number of participant reported pregnancies or pregnancy of participant's partner
Timeframe: Up to 15 Years
Number of reported pregnancy outcome(s)
Timeframe: Up to 15 Years
All cause death
Timeframe: Up to 15 Years