Stem Cell Therapy for Age-Related Macular Degeneration
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells for Age-Related Macular Degeneration?
Is stem cell therapy for macular degeneration safe?
How is the treatment using human embryonic stem cell-derived retinal pigment epithelial cells different from other treatments for age-related macular degeneration?
This treatment is unique because it uses cells derived from human embryonic stem cells to replace damaged retinal pigment epithelial cells, potentially restoring vision by forming functional layers in the eye. Unlike other treatments, it aims to directly repair the underlying cell damage in the retina.12359
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.
Research Team
Medical Monitor
Principal Investigator
Astellas Institute for Regenerative Medicine
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in a previous AIRM-sponsored clinical trial
Long-term Follow-up
Participants are monitored for late onset adverse events of special interest (AESI) through annual questionnaires
Life-long Follow-up (UK participants)
UK participants are monitored for adverse events of special interest (AESI) for life
Treatment Details
Interventions
- Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Institute for Regenerative Medicine
Lead Sponsor