What this study is
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.
What's being tested
- Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
Intervention · BIOLOGICAL
Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial
Study details
- 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
- Sponsor
- Astellas Institute for Regenerative Medicine
- Conditions
- Macular Degenerative Disease
- Enrolling
- 36 people
- Starts
- 2018-01-08
- Est. completion
- 2029-03-31
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- There are no exclusion criteria.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openPrivate Practice
Kansas City, Missouri, United States
1 site outside the US
Site GB44001
London, United Kingdom
Study team
Sponsor
Astellas Institute for Regenerative Medicine
Study ID 7316-CL-0007
Study director
Medical Monitor
Astellas Institute for Regenerative Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.