Clinical Trial

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 1/2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 72 amendments
This ClinicalTrials.gov record has been amended 72 times since 2017-05-24; most recent amendment 2026-07-10.
Status change: Not Yet Recruiting → Enrolling by Invitation 2018-02-06
Trial Details
NCT Number NCT03167203
Lead Sponsor Astellas Institute for Regenerative Medicine
Conditions Macular Degenerative Disease
Enrollment 36 participants
Start Date 2018-01-08
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13