Biomaterial-Assisted Strategies in Corneal Endothelial Cell Therapy: Toward a Platform-Based Approach.

Corneal endothelial dysfunction is a major cause of corneal blindness worldwide. This is primarily due to the limited regenerative capacity of human corneal endothelial cells (CECs) and the global shortage of donor tissues. Corneal endothelial cell therapy (CECT), which involves injecting cultured CECs into the anterior chamber, has emerged as a promising alternative to conventional transplantation. However, its clinical efficacy remains limited by several factors, including rapid cell loss, non-uniform distribution, and insufficient long-term adhesion following injection. Recent advances in biomaterials and regenerative engineering have led to the development of emerging biomaterial-assisted strategies aimed at addressing these challenges. In this review, we provide a mechanistic and translational overview of next-generation CECT, highlighting a range of biomaterial-assisted strategies aimed at improving cell retention, spatial localization, and long-term adhesion following injection. These emerging approaches aim to mitigate key limitations of conventional cell injection therapy, including variability in cell distribution and retention. However, their effectiveness and translational feasibility remain under active investigation. In addition, we analyze recent global patent trends, regulatory frameworks, and market dynamics to highlight emerging opportunities for innovation and development in this field. Although many of these technologies remain at the preclinical or early translational stage, these approaches may provide a promising direction to improve engraftment efficiency, reduce surgical variability, and enable more scalable, minimally invasive treatment options. This review highlights the potential of biomaterial-assisted CECT as a next-generation regenerative strategy and outlines key challenges that must be overcome for successful clinical translation.