Ethics of iPSC-based clinical research for age-related macular degeneration: patient-centered risk-benefit analysis

Abstract

The opportunity to undergo an induced pluripotent stem cell-based autologous transplant can strike patients as a chance for a cure from a debilitating condition with few options for respite. However, when clinical studies of this caliber present themselves, patients and researchers, each with their own set of motives, may find it difficult to take a balanced approach to evaluating them. We present a patient-centered risk-benefit analysis of the iPSC-based clinical research currently underway in Japan, including a survey of in vitro and in vivo tests that support this project, an in-depth discussion of risks, and further elucidation of considerations patients may wish to consider. The arguments presented will assist patients in undertaking a more informed decision-making process.

Fig. 1

Scheme describing the flow of how iPSCs are generated from a patient’s skin cells and differentiated into RPE cells to be transplanted into the eye of the AMD patient

Fig. 2

Two Sets of Comparisons. (A) A limited comparison of risks and benefits, as compared to (B) patient-centered decision-making process

Fig. 3

ETDRS Chart (Credit: National Eye Institute, National Institutes of Health) is used to detect subtle changes in a low-vision patient’s visual acuity