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首页> 外文期刊>Journal of Ophthalmic and Vision Research >Transplantation of autologous ex vivo expanded human conjunctival epithelial cells for treatment of pterygia: A prospective open-label single arm multicentric clinical trial
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Transplantation of autologous ex vivo expanded human conjunctival epithelial cells for treatment of pterygia: A prospective open-label single arm multicentric clinical trial

机译：自体离体扩增的人结膜上皮细胞移植治疗翼状：肉：一项前瞻性开放标签单臂多中心临床试验

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Purpose: To establish the efficacy and safety of ex vivo cultured autologous human conjunctival epithelial cell (hCjEC) transplantation for treatment of pterygia. Methods: Twenty-five patients with pterygia were recruited at different centers across the country. Autologous hCjEC grafts were prepared from conjunctival biopsy specimens excised from the healthy eye and cultured ex vivo on human amniotic membrane mounted on inserts using a unique mounting device. The hCjEC grafts were then transported in an in-house designed transport container for transplantation. Post-surgery, the patients were followed up on days 1, 7, 14, 30, 90, and 180 as per the approved study protocol. Clinical outcomes were assessed by slit lamp examination, visual acuity, imprint cytology, fluorescein/rose bengal staining, Schirmer's test, and photographic evaluation three and 6 months post-transplantation. Results: Two patients were lost to follow-up and final analysis included 23 cases. No recurrence of pterygium was observed in 18 (78.3%) patients; all of these eyes showed a smooth conjunctival surface without epithelial defects. Recurrence was observed in 5 (21.7%) patients at 3 months post-treatment. No conjunctival inflammation, secondary infections or other complications were reported. Adequate goblet cells were present in 19 (82.6%) patients at the site of transplantation. Conclusion: We have, for the 1 st time, standardized a protocol for preparing autologous hCjEC grafts that can be safely transported to multiple centers across the country for transplantation. The clinical outcome was satisfactory for treating pterygia.
机译：目的：建立离体培养自体结膜上皮细胞（hCjEC）移植治疗翼状gia肉的疗效和安全性。方法：在全国不同的中心招募了25例翼状ery肉患者。自体hCjEC移植物是由结膜活检标本制备而成的，该标本取自健康的眼睛，并用独特的固定装置在人体羊膜上离体培养，该羊膜固定在插入物上。然后将hCjEC移植物在内部设计的运输容器中运输以进行移植。手术后，按照批准的研究方案在第1、7、14、30、90和180天对患者进行随访。通过裂隙灯检查，视敏度，压印细胞学检查，荧光素/玫瑰红染色，Schirmer's检验以及移植后3和6个月的影像学评估来评估临床结果。结果：2例患者失去随访，最终分析包括23例。 18例（78.3％）患者未发现翼状re肉复发。所有这些眼睛都显示出光滑的结膜表面，没有上皮缺损。治疗后3个月，有5例（21.7％）患者出现复发。没有结膜发炎，继发感染或其他并发症的报道。在移植部位有19名（82.6％）患者中存在足够的杯状细胞。结论：我们已经第一次标准化了制备自体hCjEC移植物的协议，该协议可以安全地运输到全国各地的多个中心进行移植。治疗翼状gia肉的临床效果令人满意。

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