Nanofiber Scaffold Based Tissue Engineered Retinal Pigment Epithelium to Treat Degenerative Eye Diseases
Carl G. Simon Jr., Nathan A. Hotaling
Clinical-grade manufacturing of a functional retinal pigment epithelium (RPE) monolayer requires reproducing, as closely as possible, the natural environment in which RPE grows. In vitro, this can be achieved by a tissue engineering approach in which the RPE is grown on a nanofibrous, biological or synthetic scaffold. Recent research has shown that nanofiber scaffolds perform better than their membrane counterparts and that the success of the scaffold is not heavily material dependent but rather size and surface functionalization dependent. With these strides the field has advanced enough to begin to consider implementation of one, or a combination, of the tissue engineering strategies discussed herein in a clinical trial. Translation of the benchwork that has been done to a clinical trial involves new complexity across several fields that have not been summarized to date. Thus, here we review the current state of tissue engineering research for in vitro culture of RPE/scaffolds and the parameters for optimal scaffold design that it has uncovered. Next, we discuss production methods and manufacturers that are capable of producing the nanofiber scaffolds in such a way that would be biologically, regulatory, and clinically viable for a clinical trial. Then a discussion of how the scaffolds could be characterized, both morphologically and mechanically, to develop a testing process that is viable for regulatory screening is performed. Finally, an example of a tissue engineered RPE/scaffold construct is given to provide the reader a framework for understanding how these pieces could fit together to develop a tissue engineered RPE/scaffold construct that could pass regulatory scrutiny.
and Hotaling, N.
Nanofiber Scaffold Based Tissue Engineered Retinal Pigment Epithelium to Treat Degenerative Eye Diseases, Amerasia Journal, [online], https://doi.org/10.1089/jop.2015.0157
(Accessed December 3, 2023)