Donor tissue, comprising 2mm 2 to 5mm 2 sheets neural retina together with the adjacent RPE layer, was obtained from human fetal eyes of 10–15 weeks’ gestational age. Ten subjects with RP or age-related macular degeneration were included in this study. Vision improvement in retinal degeneration patients by implantation of retina together with retinal pigment epithelium. Images from a study subject with retinitis pigmentosa (RP) who was treated in a clinical trial of allogeneic retina and RPE transplantation (reprinted from Radtke ND, Aramant RB, Petry HM, Green PT, Pidwell DJ, Seiler MJ. The aim of this review is to summarize and appraise the safety of human retinal stem cell transplantation in the context of its potential to be developed into an effective treatment for retinal degenerative diseases.Ĭopyright © 2019 The Authors. While progress in stem cell research for blindness has been greeted with great enthusiasm by patients, scientists, doctors and industry alike, these adverse events have raised concerns about the safety of retinal stem cell transplantation and whether patients are truly protected from undue harm. However, reports of serious adverse events arising from cell therapy in other poorly regulated centers have now emerged in the lay and scientific press. These clinical trials, usually run in partnership with academic institutions, are based on sound preclinical studies and are focused on patient safety. Recently, safety data have emerged from several Phase I/II clinical trials of retinal stem cell transplantation. Stem cell transplantation holds great promise as a potential treatment for currently incurable retinal degenerative diseases that cause poor vision and blindness. 10 National Eye Institute, National Institutes of Health, Bethesda, MD, 90892, USA.9 Stein Eye Institute, University of California Los Angeles Geffen School of Medicine, Los Angeles, CA, 90095, USA Edythe and Eli Broad Stem Cell Institute, University of California Los Angeles, Los Angeles, CA, 90095, USA.8 The Vision Center, Department of Surgery, Children's Hospital Los Angeles, Los Angeles, CA, 90027, USA USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90007, USA.7 Laboratory for Retinal Regeneration, Center for Biosystems Dynamics Research, RIKEN, Kobe, Hyogo, 650-0047, Japan.6 Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford and Oxford University Eye Hospital, NHS Foundation Trust, NIHR Biomedical Research Centre, Oxford, OX3 9DU, UK.5 Gavin Herbert Eye Institute and Stem Cell Research Center, Irvine, CA, 92697, USA.4 CellSight Ocular Stem Cell and Regeneration Research Program, Department of Ophthalmology, Sue Anschutz-Rodgers Eye Center, University of Colorado School of Medicine, Aurora, CO, 80045, USA.3 Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, 33136, USA. Electronic address: 2 Department of Ophthalmology & Vision Science, University of California-Davis Eye Center, Sacramento, CA, 95817, USA.
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