A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Enrolling by invitation · Phase 1/Phase 2

Conditions studied: Macular Degenerative Disease

In brief

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.

Key facts

Study ID

NCT03167203

Run by

Astellas Institute for Regenerative Medicine

People needed

36

Starts

2018-01-08

Expected to finish

2029-03-31

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease.
• Participant is able to understand.

You may not qualify if…

• There are no exclusion criteria.

Where it is running

• Private Practice — Kansas City, Missouri, United States
• Site GB44001 — London, United Kingdom

Full record on ClinicalTrials.gov

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