Safety, structure and function five years after hESC-RPE patch transplantation in acute neovascular AMD with submacular haemorrhage

We observed patch pigmentation corresponding to OCT signals suggesting persistence of transplanted RPE in both patients at 5 years (Fig. 1. A2 and B2, Fig. 2. A4 and B4). We cannot be certain whether this was because of the surgery, the health of the neuroretina, the function of the choriocapillaris or a low-grade, chronic rejection-related inflammation, as no histology is available.

Sustained BCVA improvement to 2 years for subject 1, and, 5 years for subject 2 was recorded, though it is not possible to attribute the improvement to the RPE transplant alone in the absence of a controls. Improvements in vision have been seen with removal of blood alone [5], but these results suggests that the transplanted RPE may be capable of sustaining retinal function long-term.

In terms of safety, there was no uncontrolled proliferation or tumorigenicity and no clinically evident intraocular inflammation over the five-year period. Both subjects received oral and topical steroids as immunosuppression as described previously [1]. In both subjects epiretinal and sub-retinal fibrosis was seen and in subject 2 a PVR retinal detachment occurred, which did not occur or progress after the 1st 12 months. It is possible that the fibrosis and retinal detachments were related to the transplanted RPE or the underlying neovascular AMD combined with retinal surgery.

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