Bioengineered corneal stroma: from laboratory to clinical adoption

Abstract

AbstractBlindness caused by corneal stromal disease and injuries affects millions worldwide, with the greatest burden in low‐ to middle‐income countries with inadequate donation and tissue banking infrastructure to meet the demand for sight‐restoring corneal transplantation. We bioengineered a regenerative cell‐free corneal scaffold from medical‐grade type I collagen and developed a minimally‐invasive implantation method avoiding the need for surgical suturing or long‐term immunosuppression. Applying good manufacturing practices and third‐party certified biocompatibility, toxicity, sterility and long‐term shelf life studies, sterile corneal scaffolds were tested in preclinical animal models and in a first clinical case series. Scaffolds integrated with recipient tissue and supported host cell ingrowth without inflammation or scarring. 22 subjects with advanced keratoconus were implanted with the bioengineered scaffold without complications. During 6–12 months of follow‐up, no rejection, inflammation, vascularization or adverse event occurred. Visual acuity, spherical refractive error, keratometry, corneal thickness and volume all improved significantly in the cohorts. Initially contact lens‐intolerant patients were tolerant postoperatively and are eligible for refractive surgery to optimize visual acuity. Results indicate bioengineered scaffold implantation can restore vision in patients with advanced stromal disease, avoiding more invasive procedures and the need for donor tissue.