诱导多能干细胞衍生的角膜上皮质用于移植手术:日本的一项单臂,开放式,首次对人进行的干预研究
Takeshi Soma1, Yoshinori Oie1, Hiroshi Takayanagi1
1Department of Ophthalmology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
Lancet (London, England)
|November 10, 2024
概括
人类诱导的多能干细胞衍生角膜上皮细胞表 (iCEPS) 显示出治疗肢体干细胞缺乏症 (LSCD) 的前景. 这项全球首次的临床研究发现iCEPS移植在改善LSCD患者的视力和角膜健康方面是安全和有效的.
科学领域:
- 眼科 眼科
- 干细胞生物学
- 复原医学
背景情况:
- 脊髓干细胞缺陷严重影响视力,难以治疗.
- 这种对角膜健康至关重要的边缘体含有上皮干细胞,其损失导致LSCD.
- 目前对LSCD的治疗方法往往不足,需要新的治疗方法.
研究的目的:
- 评估人类诱导多能干细胞衍生角膜上皮细胞表 (iCEPSs) 的安全性和有效性,用于治疗LSCD.
- 报告世界上首次在LSCD患者中使用iPSC衍生角膜细胞片.
- 评估iCEPS移植后的视力敏度,角膜状况和不良事件.
主要方法:
- 这是一项非随机的单臂临床研究,涉及四名LSCD患者.
- 在受影响的眼睛中移植人类IPSC衍生的角膜上皮细胞 (iCEPSs).
- 在52周的随访期和1年的安全期内持续监测不良事件.
主要成果:
- 在2年的监测期间,没有观察到包括瘤发生或临床排斥在内的严重不良事件.
- 在52周,所有接受治疗的眼睛都出现了疾病阶段的改善,远距离视觉敏度得到了纠正,角膜化减少.
- 角膜上皮缺陷,症状,生活质量和新血管通常改善或保持稳定.
结论:
- 来自iPSC的角膜上皮细胞表 (iCEPS) 移植是一种安全且可能有效的LSCD治疗方法.
- 这项研究为更大的临床试验提供了基础,以进一步验证iCEPS的疗效.
- 这种再生方法为严重的角膜损伤患者恢复视力提供了有前途的新途径.
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