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Nanofiber Scaffold-Based Tissue-Engineered Retinal Pigment Epithelium to Treat Degenerative Eye Diseases.

  • Hotaling, Nathan A1, 2
  • Khristov, Vladimir3
  • Wan, Qin3
  • Sharma, Ruchi2
  • Jha, Balendu Shekhar2
  • Lotfi, Mostafa3
  • Maminishkis, Arvydas3
  • Simon, Carl G Jr1
  • Bharti, Kapil2
  • 1 1 Biosystems and Biomaterials Division, National Institute of Standards and Technology , Gaithersburg, Maryland.
  • 2 2 Unit on Ocular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health , Bethesda, Maryland.
  • 3 3 Section of Epithelial and Retinal Physiology and Disease, National Eye Institute, National Institutes of Health , Bethesda, Maryland.
Published Article
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
Publication Date
Jun 01, 2016
DOI: 10.1089/jop.2015.0157
PMID: 27110730


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 for cell growth and transplantability compared with their membrane counterparts and that the success of the scaffold in promoting cell growth/function is not heavily material 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 this study, we review the current state of tissue engineering research for in vitro culture of RPE/scaffolds and the parameters for optimal scaffold design that have been uncovered during this research. Next, we discuss production methods and manufacturers that are capable of producing the nanofiber scaffolds in such a way that would be biologically, regulatory, clinically, and commercially viable. 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 can be commercially successful.

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