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Long-Term Safety Surveillance of hESC-RPE Cell Therapy in Macular Degenerative Disease
NCT03167203Phase 2
Key facts
- Status
- Enrolling by invitation
- Start
- Jan 2018
- Primary completion
- Mar 2029
- Countries
- 2
- Modality
- Patient-derived iPSCs, Allogeneic iPSCs
- Drugs
- ASP7316
- Conditions
- age-related macular degeneration (AMD)
01
Overview
Phase 2, open-label, single-arm trial of ASP7316 in age-related macular degeneration (AMD), sponsored by Astellas Institute for Regenerative Medicine. Primary endpoints: Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic at 15 years, Number of new diagnoses of an immune-mediated disorder at 15 years and 6 more. Started Jan 2018; status: enrolling by invitation.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
hESC-RPE cells
Participants previously enrolled into an AIRM sponsored clinical trial and treated with Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial (hESC-RPE) cells.
03
Who it enrols
Participants must have been previously treated with hESC-RPE cell therapy in an AIRM-sponsored clinical trial for macular degenerative disease.
04
Endpoints
Primary
Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic
Number of new diagnoses of an immune-mediated disorder
Incidents of new cancer, irrespective of prior history
Incidents of hESC-RPE cell proliferation
Incidents of ectopic tissue (RPE or non-RPE) formation
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