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Q-CTS-hESC-2-RPE is a clinical-grade retinal pigment epithelium (RPE) cell therapy derived from the human embryonic stem cell line Q-CTS-hESC-2. It is developed for subretinal transplantation to treat degenerative retinal diseases, including wet age-related macular degeneration (wet AMD) and Stargardt macular degeneration (STGD1). The cells are manufactured under good manufacturing practice (GMP) conditions and have demonstrated biosafety, genetic stability, and functional efficacy in preclinical models as well as early-phase clinical trials. Mechanistically, the therapy aims to replace or support dysfunctional RPE cells in the retina, thereby preserving or improving visual function[1][2][3][4][5]. The product has been shown to be pathogen-free and non-tumorigenic in animal studies[1][2].
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