Centre for Regenerative Medicine 'Stefano Ferrari', University of Modena & Reggio Emilia, Modena, Italy.
Regen Med. 2013 Sep;8(5):553-67. doi: 10.2217/rme.13.43. Epub 2013 Jun 3.
Limbal cultures restore the corneal epithelium in patients with ocular burns. We investigated the biological parameters instrumental for their clinical success.
We report a long-term multicenter prospective study on 152 patients carrying corneal destruction due to severe ocular burns, treated with autologous limbal cells cultured on fibrin and clinical-grade 3T3-J2 feeder cells. Clinical results were statistically evaluated both by parametric and nonparametric methods.
Clinical outcomes were scored as full success, partial success and failure in 66.05, 19.14 and 14.81% of eyes, respectively. The total number of clonogenic cells, colony size, growth rate and presence of conjunctival cells could not predict clinical results. Instead, the clinical data provided conclusive evidence that graft quality and likelihood of a successful outcome rely on an accurate evaluation of the number of stem cells detected before transplantation as holoclones expressing high levels of the p63 transcription factor. No adverse effects related to the feeder layer have been observed and the regenerated epithelium was completely devoid of any 3T3-J2 contamination.
Cultures of limbal stem cells can be safely used to successfully treat massive destruction of the human cornea. We emphasize the importance of a discipline for defining the suitability and the quality of cultured epithelial grafts, which are relevant to the future clinical use of any cultured cell type.
角膜缘培养可使眼烧伤患者的角膜上皮得以修复。我们研究了对其临床成功有帮助的生物学参数。
我们报告了一项针对 152 例因严重眼烧伤导致角膜破坏的患者的长期多中心前瞻性研究，这些患者接受了自体角膜缘细胞培养物在纤维蛋白和临床级 3T3-J2 饲养细胞上的治疗。采用参数和非参数方法对临床结果进行了统计学评估。
分别有 66.05%、19.14%和 14.81%的眼被评为完全成功、部分成功和失败。克隆形成细胞总数、集落大小、增长率和结膜细胞的存在均不能预测临床结果。相反，临床数据提供了确凿的证据，即移植物质量和成功结果的可能性依赖于在移植前对检测到的干细胞数量进行准确评估，表现为高表达 p63 转录因子的全能细胞。未观察到与饲养层相关的不良反应，再生的上皮完全没有任何 3T3-J2 污染。
培养的角膜缘干细胞可安全用于成功治疗人类角膜的大面积破坏。我们强调了为培养的上皮移植物的适用性和质量制定规范的重要性，这与未来任何培养细胞类型的临床应用相关。
