Purpose

This double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sjögren's syndrome (SS).

Methods

Fifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor® CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up.

Results

A significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups.

Conclusion

Improvement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.

中文翻译：

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同种异体间充质干细胞治疗干燥综合征患者干眼症：一项随机临床试验

目的

这项双盲随机临床试验旨在评估将同种异体脂肪来源的间充质干细胞（ASC）注射到泪腺（LG）中治疗继发于干燥综合征（ SS）的干眼病（DED）的疗效。

方法

54 名继发于 SS 的严重 DED 参与者被纳入研究，并被分配到 ASC（n = 20）、车辆组（n = 20）或非随机观察组（n = 14）。干预组在一只眼睛的 LG 中单次注射 ASC 或活性比较剂（载体，Cryostor® CS10），而观察组仅接受润滑滴眼液。主要结局指标是眼表疾病指数 (OSDI) 评分的变化，次要结局指标是12 个月随访内的无创泪液破裂时间、泪液半月板高度、Schirmer 试验和牛津评分。

结果

与观察组相比，ASC 组和媒介物组的 OSDI 评分显着降低。此外，与赋形剂组相比，ASC 组在 4 周的随访中和在 12 个月的随访中与观察组相比，非侵入性泪膜破裂时间显着增加。ASC 组的眼表染色、泪液渗透压和 Schirmer 测试评分也较基线有显着改善；然而，与其他组相比，这些变化并不显着。

结论

与观察组相比，在 LG 注射后，两个干预组均观察到 DED 的主观和客观体征和症状有所改善。未来的研究应该调查两种注射治疗的作用方式。