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. 2019 Aug 27;4:19. doi: 10.1038/s41536-019-0081-8

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© The Author(s) 2019

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — A Strategic Roadmap of Clinical & Regulatory Development for hESC-RPE Transplant. This figure provides a strategic roadmap of clinical regulatory development framework pertinent to hESC-RPE cell line optimization and validation through adaptive clinical trials in small patient cohorts. It depicts a viable and cost-effective translational path, back and forth between in vitro cell line optimization and early stage clinical trials, which has strategic importance to the development and commercialization of hESC-derived cell therapies. This roadmap entails decades of development work in order to generate an ideal or biologically competent hRPE line for global commercialization. However, an expedited or conditional approval with term-limited authorization may be possible as the second- or third-generation cell line enters into Phase 1/2 or proof of concept clinical trials, of which if the study results can predict clinical efficacy with reproducibility and confirming product safety.^33,34