Clinical-grade retinal implant made of human embryonic stem cell (hESC)–derived RPE grown on a synthetic substrate may have potential therapeutic effects on visual acuity, suggesting that it can be useful for treating retinal disorders.
Retinal implants developed from human embryonic stem cell (hESC) may be safe for the treatment of vision loss caused by a type of macular degeneration, which is a progressive blinding disease. The findings from the phase 1/2a clinical trial (which encompasses two phases of analysis) may pave the way to a potential new therapy for advanced non-neovascular age-related macular degeneration (or NNAMD, also known as "Dry" AMD). NNAMD is associated with loss of the retinal pigment epithelium (RPE), a membrane that nourishes and protects retinal visual cells in the eye.
‘A bioengineered retinal implant made of human embryonic stem cell seems to be safe for the treatment of a progressive blinding disease known as ‘non-neovascular age-related macular degeneration’ (NNAMD).’
Here, Amir Kashani and colleagues examined the safety and efficacy of a bioengineered retinal implant, which they previously developed and tested in rodents. Their implant is composed of human embryonic stem cells that rest on a material and form a membrane, mimicking the RPE. The authors inserted the implant into the eyes of four subjects with advanced NNAMD and monitored their vision over the course of four months to a year. The implant was well tolerated by all four subjects, who maintained their vision throughout the duration of the study (one even demonstrated an observable improvement in visual acuity). Furthermore, post-operative images revealed stem cells in the implants successfully integrated with the subjects' retinal tissue, and their retinas exhibited anatomical changes consistent with reappearance of the RPE. As a next step, the researchers plan to conduct larger prospective studies to further assess the efficacy of the implant for treating NNAMD in humans.
Source-Eurekalert