Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial
Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial
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视神经管减压联合脐带间充质干（基质）细胞治疗间接创伤性视神经病变：1 期临床试验
DOI：
10.1159/000512469
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发表时间：
2021-06-01
影响因子：
2.1
通讯作者：
Xu, Xiang
中科院分区：
文献类型：
--
作者：
Li, Jia;Bai, Xu;Xu, Xiang
目的：这项研究的目的是研究脐带衍生的间充质干细胞（MSC）移植的安全性和可行性。方法：这是一项单一中心，前瞻性，标记的第一阶段研究，招募了20名TON患者。患者连续进行视管减压与MSC局部植入治疗（第1组）或仅视管减压（第2组）结合使用。术后第一天，第七天，第一个月和第六个月对患者进行评估。每次访问都记录了不良事件，例如发烧，荨麻疹病变，鼻感染和死亡。主要结果是最校正视力的变化。次要结果是彩色视觉，相对传入的瞳孔缺陷以及闪光视觉引起的潜力的变化。结果：所有20名患者均完成了为期6个月的随访。他们都没有任何系统性或眼部并发症。在第1组和第2组之间，随访时最校正的视力变化并没有显着差异（p> 0.05）。但是，第1组的视觉结果比第2组更好。与基线相比，两组的视力均有显着改善（p <0.05）。但是，两组之间没有统计学上的显着差异（p> 0.05）。此外，在患者中未观察到与局部移植有关的不良事件。结论：视神经中的单个局部MSC移植对TON患者是安全的。
Purpose: This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). Methods: This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. Results: All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (p > 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (p < 0.05); however, there were no statistically significant differences between the groups (p > 0.05). In addition, no adverse events related to local transplantation were observed in the patients. Conclusions: A single, local MSC transplantation in the optic nerve is safe for patients with TON.