Purpose

To report electroretinographic (ERG) findings in advanced glaucoma treated with a single intravitreal injection of bone marrow-derived mesenchymal stem cells (MSCs).

Methods

Intravitreal injection of autologous MSCs (1 × 10⁶ cells) was performed in 2 eyes from 2 patients with open-angle glaucoma in advanced stage of optic neuropathy (ClinicalTrials.gov, NCT02330978, 01.05.2015): cup/disk ratio worse than 0.9, visual field mean deviation index lower than − 15 dB, visual acuity of light perception, but controlled intraocular pressure. ERG tests were recorded at baseline and week 1, 4 and 48 after injection, using DTL electrodes following the ISCEV standard: After dark adaptation, ERG was elicited using white flashes of 0.01 cd.s/m² and 3.0 cd.s/m², followed by 10-min light adaptation (30 cd/m²) and stimuli of 3.0 cd.s/m² and 30 Hz flicker.

Results

Patients did not show improvement on visual acuity or visual field after treatment. At baseline, ERG responses showed typical findings for advanced glaucoma, with a- and b-wave amplitude and latency within normative range, but reduced photopic negative responses. No noteworthy changes were observed on ERG responses for both cases up to 1 week after treatment, but at day 15, one patient showed retinal detachment with proliferative vitreoretinopathy and was removed from the trial. The other patient kept ERG responses stable throughout study period.

Conclusion

Although no ERG response changes were observed after MSCs injection in one case, the complication observed on the second one, along with the lack of visual function improvement, warrants further studies involving modified MSCs to treat ocular disorders, including glaucoma.

Trial registration: ClinicalTrials.gov, NCT02330978- missed in pdf

中文翻译：

---

晚期青光眼玻璃体内注射自体骨髓间充质基质细胞后的视网膜功能

目的

报告单次玻璃体内注射骨髓来源的间充质干细胞 (MSCs) 治疗晚期青光眼的视网膜电图 (ERG) 发现。

方法

对 2 名晚期视神经病变开角型青光眼患者的 2 只眼进行玻璃体内注射自体 MSCs（1 × 10 ⁶细胞）（ClinicalTrials.gov, NCT02330978, 01.05.2015）：杯盘比低于 0.9 ，视野平均偏差指数低于-15dB，光感视力，但眼压可控。使用遵循 ISCEV 标准的 DTL 电极在基线和注射后第 1、4 和 48 周记录 ERG 测试：暗适应后，使用 0.01 cd.s/m ²和 3.0 cd.s/m ²的白色闪光引发 ERG ，然后是 10 分钟的光适应 (30 cd/m ² ) 和 3.0 cd.s/m ²和 30 Hz 闪烁的刺激。

结果

治疗后患者的视力或视野没有改善。在基线时，ERG 反应显示晚期青光眼的典型发现，a 波和 b 波振幅和潜伏期在正常范围内，但明视负反应减少。在治疗后长达 1 周内，两种病例的 ERG 反应均未观察到值得注意的变化，但在第 15 天，一名患者出现视网膜脱离伴增殖性玻璃体视网膜病变，并被排除在试验之外。另一名患者在整个研究期间保持 ERG 反应稳定。

结论

尽管在一个病例中，在注射 MSCs 后没有观察到 ERG 反应变化，但在第二个病例中观察到的并发症，以及缺乏视觉功能改善，值得进一步研究涉及改良的 MSCs 来治疗包括青光眼在内的眼部疾病。

试验注册： ClinicalTrials.gov，NCT02330978- pdf 中遗漏