Numa Kohsaku, Imai Kojiro, Ueno Morio, Kitazawa Koji, Tanaka Hiroshi, Bush John D, Teramukai Satoshi, Okumura Naoki, Koizumi Noriko, Hamuro Junji, Sotozono Chie, Kinoshita Shigeru
Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Ophthalmology. 2021 Apr;128(4):504-514. doi: 10.1016/j.ophtha.2020.09.002. Epub 2020 Sep 6.
To report the safety and efficacy of a novel cell injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group.
Prospective observational study.
This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC injection therapy between December 2013 and December 2014.
All patients underwent follow-up examinations at 1 week, 4 weeks, 12 weeks, and 24 weeks and 1 year, 2 years, 3 years, 4 years, and 5 years after surgery. Specific corneal endothelial cell parameters (i.e., corneal endothelial cell density [ECD], coefficient of variation of area, and percentage of hexagonal cells) and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure (IOP) were recorded.
The primary outcome was the change in central ECD after cell injection therapy, and the secondary outcome was corneal thickness, BCVA, and IOP during the 5-year-postoperative follow-up period.
At 5 years after surgery, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean ± standard deviation central corneal ECD was 1257 ± 467 cells/mm (range, 601-2067 cells/mm), BCVA improved significantly in 10 treated eyes, the mean visual acuity changed from 0.876 logarithm of the minimum angle of resolution before surgery to 0.046 logarithm of the minimum angle of resolution after surgery, and no major adverse reactions directly related to the hCEC injection therapy were observed.
The findings in this study confirmed the safety and efficacy of cultured hCEC injection therapy for up to 5 years after surgery.
通过首个入组人体临床试验组5年术后长期临床数据报告，阐述一种使用培养的人角膜内皮细胞（hCEC）治疗内皮功能衰竭的新型细胞注射疗法的安全性和有效性。
前瞻性观察研究。
本研究纳入了11例人工晶状体植入术后内皮功能衰竭患者的11只眼睛，这些患者于2013年12月至2014年12月接受了hCEC注射治疗。
所有患者在术后1周、4周、12周、24周以及1年、2年、3年、4年和5年接受随访检查。记录特定的角膜内皮细胞参数（即角膜内皮细胞密度[ECD]、面积变异系数和六角形细胞百分比）、中央角膜厚度、Landolt C视力表上的最佳矫正视力（BCVA）以及眼压（IOP）。
主要观察指标是细胞注射治疗后中央ECD的变化，次要观察指标是术后5年随访期间的角膜厚度、BCVA和IOP。
术后5年，11只眼中有10只恢复了正常角膜内皮功能，中央角膜ECD的平均值±标准差为1257±467个细胞/mm²（范围为601 - 2067个细胞/mm²），10只接受治疗的眼睛的BCVA显著改善，平均视力从手术前的最小分辨角对数0.876变为手术后的最小分辨角对数0.046，且未观察到与hCEC注射治疗直接相关的重大不良反应。
本研究结果证实了培养的hCEC注射疗法在术后长达5年的安全性和有效性。
