Translational and Regulatory Challenges of Corneal Endothelial Cell Therapy: A Global Perspective

Cell therapies are emerging as a unique class of clinical therapeutics in medicine. In 2015, Holoclar ( ex vivo expanded autologous human corneal epithelial cells containing stem cells) gained the regulatory approval for treating limbal stem cell deficiency after chemical eye burn. This has set a pr...

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Bibliographic Details
Published in:Tissue engineering. Part B, Reviews Reviews, 2022-02, Vol.28 (1), p.52-62
Main Authors: Ting, Darren Shu Jeng, Peh, Gary S L, Adnan, Khadijah, Mehta, Jodhbir S
Format: Article
Language:English
Subjects:
Autografts
Blindness
Cell therapy
Cornea
Corneal Diseases - therapy
Corneal Transplantation
Developing countries
Endothelial Cells
Endothelium
Endothelium, Corneal
Epithelial Cells
Eye diseases
Humans
LDCs
Regulatory approval
Review Articles
Stem cells
Translation
Trauma
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Summary:Cell therapies are emerging as a unique class of clinical therapeutics in medicine. In 2015, Holoclar ( ex vivo expanded autologous human corneal epithelial cells containing stem cells) gained the regulatory approval for treating limbal stem cell deficiency after chemical eye burn. This has set a precedent in ophthalmology and in medicine, reinforcing the therapeutic promise of cell therapy. However, to generalize and commercialize cell therapies on a global scale, stringent translational and regulatory requirements need to be fulfilled at both local and international levels. Over the past decade, the Singapore group has taken significant steps in developing human corneal endothelial cell (HCEnC) therapy for treating corneal endothelial diseases, which are currently the leading indication for corneal transplantation in many countries. Successful development of HCEnC therapy may serve as a novel solution to the current global shortage of donor corneas. Based on the experience in Singapore, this review aims to provide a global perspective on the translational and regulatory challenges for bench-to-bedside translation of cell therapy. Specifically, we discussed about the characterization of the critical quality attributes (CQA), the challenges that can affect the CQA, and the variations in the regulatory framework embedded within different regions, including Singapore, Europe, and the United States.
ISSN:1937-3368
1937-3376
DOI:10.1089/ten.teb.2020.0319