Stem Cell Therapy for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Astellas Institute for Regenerative Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This study is for people who have previously received a specific stem cell treatment for macular degeneration in an AIRM-sponsored trial. Participants must be able to understand the nature of this follow-up study.

Inclusion Criteria

I have received hESC-RPE cell therapy for macular degeneration in an AIRM trial.

Participant is able to understand

Exclusion Criteria

There are no exclusion criteria

Participant Groups

The focus is on monitoring safety long-term, specifically looking for late onset adverse events that might be related to the stem cell therapy they received over 5 years ago.

1Treatment groups

Experimental Treatment

Group I: hESC-RPE cellsExperimental Treatment1 Intervention

Participants previously enrolled into an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial and treated with Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial (hESC-RPE) cells