Japanese regenerative medicine startup Cellusion announced it has transplanted its pluripotent stem-cell (iPS)-derived corneal endothelial cell substitute, CLS001, into its first human patient.
Led by Professor Shigeto Shimmura of Fujita Health University and Keio University Department of Ophthalmology, the study aims to evaluate the safety and efficacy of CLS001 in patients with regrafted cases of bullous keratopathy. Prof Shimmura reported no adverse events were observed for three months after transplantation, while visual acuity, central corneal thickness and minimal corneal thickness improved.
Cellusion said it expects CLS001 to reduce the current donor cornea supply limitations by combining CLS001’s “excellent” proliferative properties with a simple injection delivery procedure requiring “no human expertise”.
Vyznova cell therapy approved
In other news, US and Japan-based Aurion Biotech received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Vyznova, its novel cell therapy for the treatment of bullous keratopathy. Aurion’s therapy involves culturing donor cornea cells to produce off-the-shelf, allogeneic, fully differentiated corneal endothelial cells able to regenerate outside the body, in theory allowing a single donor to treat more than 100 recipient eyes.
