LinkoCare Life Sciences AB, Linköping, Sweden.
Department of Biomedical Engineering, Linköping University, Linköping, Sweden.
Nat Biotechnol. 2023 Jan;41(1):70-81. doi: 10.1038/s41587-022-01408-w. Epub 2022 Aug 11.
Visual impairment from corneal stromal disease affects millions worldwide. We describe a cell-free engineered corneal tissue, bioengineered porcine construct, double crosslinked (BPCDX) and a minimally invasive surgical method for its implantation. In a pilot feasibility study in India and Iran (clinicaltrials.gov no. NCT04653922 ), we implanted BPCDX in 20 advanced keratoconus subjects to reshape the native corneal stroma without removing existing tissue or using sutures. During 24 months of follow-up, no adverse event was observed. We document improvements in corneal thickness (mean increase of 209 ± 18 µm in India, 285 ± 99 µm in Iran), maximum keratometry (mean decrease of 13.9 ± 7.9 D in India and 11.2 ± 8.9 D in Iran) and visual acuity (to a mean contact-lens-corrected acuity of 20/26 in India and spectacle-corrected acuity of 20/58 in Iran). Fourteen of 14 initially blind subjects had a final mean best-corrected vision (spectacle or contact lens) of 20/36 and restored tolerance to contact lens wear. This work demonstrates restoration of vision using an approach that is potentially equally effective, safer, simpler and more broadly available than donor cornea transplantation.
角膜基质疾病导致的视力障碍影响着全球数百万人。我们描述了一种无细胞工程化角膜组织，生物工程猪构建体，双交联（BPCDX），以及一种用于其植入的微创外科方法。在印度和伊朗的一项初步可行性研究中（clinicaltrials.gov 编号：NCT04653922），我们将 BPCDX 植入 20 名晚期圆锥角膜患者的角膜中，以重塑天然角膜基质，而无需去除现有组织或使用缝线。在 24 个月的随访期间，未观察到不良事件。我们记录了角膜厚度的改善（印度的平均增加 209 ± 18 µm，伊朗的平均增加 285 ± 99 µm），最大角膜曲率（印度的平均减少 13.9 ± 7.9 D，伊朗的平均减少 11.2 ± 8.9 D）和视力（印度的平均接触镜矫正视力达到 20/26，伊朗的平均眼镜矫正视力达到 20/58）。在最初失明的 14 名患者中，有 14 名患者的最终平均最佳矫正视力（眼镜或接触镜）为 20/36，并恢复了对接触镜佩戴的耐受性。这项工作证明了通过一种潜在地同样有效、更安全、更简单且更广泛可用的方法恢复视力，其效果与供体角膜移植相当。
