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自体骨髓间充质干细胞玻璃体内注射治疗晚期青光眼后的视网膜功能。

Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma.

机构信息

Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - 12º. Andar, Ribeirão Preto, São Paulo, 14049 - 900, Brazil.

Department of Medical Images, Hematology and Clinical Oncology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.

出版信息

Doc Ophthalmol. 2021 Aug;143(1):33-38. doi: 10.1007/s10633-021-09817-z. Epub 2021 Jan 19.

Abstract

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 × 10 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/m and 3.0 cd.s/m, followed by 10-min light adaptation (30 cd/m) and stimuli of 3.0 cd.s/m 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.

摘要

目的

报告骨髓间充质干细胞(MSCs)单次玻璃体内注射治疗晚期青光眼的视网膜电图(ERG)结果。

方法

对 2 例晚期开角型青光眼伴视神经病变(视野平均缺损指数低于-15dB,杯盘比大于 0.9,光感视力,但眼压控制良好)患者的 2 只眼进行了玻璃体内注射自体 MSCs(1×10 个细胞)(ClinicalTrials.gov,NCT02330978,2015 年 5 月 1 日)。采用 DTL 电极,按照 ISCEV 标准,在基线及注射后 1、4、48 周记录 ERG 检查:暗适应后,用 0.01 cd.s/m 和 3.0 cd.s/m 的白色闪烁光诱发 ERG,然后进行 10 分钟的明适应(30 cd/m)和 3.0 cd/s/m 和 30 Hz 闪烁刺激。

结果

治疗后患者视力或视野均无改善。在基线时,ERG 反应显示出晚期青光眼的典型表现,a 波和 b 波的幅度和潜伏期均在正常范围内,但光负反应降低。治疗后 1 周内,2 例患者的 ERG 反应均无明显变化,但在第 15 天,1 例患者出现视网膜脱离伴增生性玻璃体视网膜病变,被排除在试验之外。另一位患者在整个研究期间保持 ERG 反应稳定。

结论

尽管在一例患者中注射 MSCs 后没有观察到 ERG 反应变化,但在第二例患者中观察到的并发症,以及视觉功能改善的缺乏,需要进一步研究改良的 MSCs 治疗眼部疾病,包括青光眼。

试验注册

ClinicalTrials.gov,NCT02330978-在 PDF 中遗漏。

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