一项扩大的临床试验测试了一种突破性的实验性干细胞治疗致盲性角膜损伤的方法，结果发现，在14名接受了治疗并随访了18个月的患者中，这种治疗方法是可行和安全的，而且完全或部分成功的比例很高。

An expanded clinical trial that tested a groundbreaking, experimental stem cell treatment for blinding cornea injuries found the treatment was feasible and safe in 14 patients who were treated and followed for 18 months, and there was a high proportion of complete or partial success.

这项新的1/2阶段试验的结果于2025年3月4日发表在《自然通讯》上。

The results of this new phase 1/2 trial published March 4, 2025 in Nature Communications.

这种疗法被称为培养的自体角膜缘上皮细胞（CALEC），是由麻省总医院布里格姆医疗保健系统的成员Mass Eye and Ear开发的。

The treatment, called cultivated autologous limbal epithelial cells (CALEC), was developed at Mass Eye and Ear, a member of the Mass General Brigham healthcare system.

这项创新的手术包括通过活组织检查从健康的眼睛中取出干细胞，通过一种新的制造工艺将其扩展成细胞组织移植物，然后将移植物手术移植到角膜受损的眼睛中，这需要两到三周的时间。

The innovative procedure consists of removing stem cells from a healthy eye with a biopsy, expanding them into a cellular tissue graft in a novel manufacturing process that takes two to three weeks, and then surgically transplanting the graft into the eye with a damaged cornea.

研究人员发现，在3个月的随访中，CALEC完全恢复了50%的参与者的角膜，在12个月和18个月的随访中，完全成功率分别增加到79%和77%。

Researchersshowed CALEC completely restored the cornea in 50% of participants at their 3-month visit and that rate of complete success increased to 79% and 77% at their 12- and 18-month visits, respectively.

当一个人遭受角膜损伤，如化学烧伤、感染或其他创伤时，它会耗尽角膜缘上皮细胞，这些细胞永远无法再生。

When a person suffers a cornea injury, such as a chemical burn, infection or other trauma, it can deplete the limbal epithelial cells, which can never regenerate.

患有这些损伤的人通常会经历持续的疼痛和视力障碍。

People with these injuries often experience persistent pain and visual difficulties.

作为一种自体治疗，这种方法的一个局限性是患者必须只有一只受累的眼睛，因此可以从未受影响的正常眼睛进行活检以获得起始材料。

As an autologous therapy, one limitation of this approach is that it is necessary for the patient to have only one involved eye so a biopsy can be performed to get starting material from the unaffected normal eye.

Journal Reference:

Jurkunas, U.V., Kaufman, A.R., Yin, J. et al. Cultivated autologous limbal epithelial cell (CALEC) transplantation for limbal tem cell deficiency: a phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the US.. Nat Commun, 2025 DOI: 10.1038/s41467-025-56461-1