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A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
Sponsor: Astellas Institute for Regenerative Medicine
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.
Official title: A Safety Surveillance Study of Events of Special Interest Occurring in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2018-01-08
Completion Date
2029-03-31
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial
Locations (2)
Private Practice
Kansas City, Missouri, United States
Site GB44001
London, United Kingdom