Human retinal pigment epithelial cell therapy

Unassigned

New Medicines

Stargardt's disease

Information

Advanced therapy medicinal product (ATMP)
Astellas
Astellas

Development and Regulatory status

Phase II Clinical Trials
None
Phase II Clinical Trials
Yes
Yes

Category

Allogeneic retinal pigment epithelial (RPE) cells dervied from embryonic stem cells given by uniocular subretinal injection
Stargardt's disease, with or without fundus flavimaculatus, is the most common hereditary dystrophy affecting the central retina, occurring in 1 in 8,000-10,000 people. Also known as juvenile macular dystrophy: this is one of the two most common forms of inherited macular degeneration. It accounts for 7% of all retinal dystrophies. It is a progressive, bilateral atrophic macular dystrophy characterised by perimacular and peripheral dirty grey-yellow spots (fundus flavimaculatus) [1].
Stargardt's disease
Subretinal injection
Intraocular