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土耳其安卡拉大学脐带间充质干细胞治疗RP

本文章介绍了土耳其安卡拉大学眼科医院在2019年4月至2019年10月用脐带间充质干细胞针对视网膜色素变性进行的第三期临床试验

32位RP患者(34只眼)纳入研究,Tenon氏囊下注入间充质干细胞,治疗6个月后视力提高10.1个字母数,视野改善,外层视网膜厚度增加,多焦视网膜电图幅值增加,视网膜电图潜时缩短,未出现任何眼部和全身不良事件,证实Tenon氏囊下注射治疗RP是安全有效的。

Management of retinitis pigmentosa by
Wharton’s jelly derived mesenchymal stem
cells: preliminary clinical results
Emin ÖZMERT1 and Umut ARSLAN2*
Abstract
Purpose: The aim of this study is to determine if umbilical cord Wharton’s jelly derived mesenchymal stem cells
implanted in sub-tenon space have beneficial effects on visual functions in retinitis pigmentosa patients by
reactivating the degenerated photoreceptors in dormant phase.
Material and methods: This prospective, open-label, phase-3 clinical trial was conducted between April of 2019 and
October of 2019 at Ankara University Faculty of Medicine, Department of Ophthalmology. 32 RP patients (34 eyes)
were included in the study. The patients were followed for 6 months after the Wharton’s jelly derived mesenchymal
stem cell administration, and evaluated with consecutive examinations. All patients underwent a complete routine
ophthalmic examination, and best corrected visual acuity, optical coherens tomography angiography, visual field,
multifocal and full-field electroretinography were performed. The quantitative results were obtained from a comparison
of the pre-injection and final examination (6th month) values.
Results: The mean best corrected visual acuity was 70.5 letters prior to Wharton’s jelly derived mesenchymal stem cell
application and 80.6 letters at the 6th month (p = 0.01). The mean visual field median deviation value was 27.3 dB
before the treatment and 24.7 dB at the 6th month (p = 0.01). The mean outer retinal thickness was 100.3 μm before
the treatment and 119.1 μm at 6th month (p = 0.01). In the multifocal electroretinography results, P1 amplitudes
improved in ring1 from 24.8 to 39.8 nv/deg2 (p = 0.01), in ring2 from 6.8 to 13.6 nv/deg2 (p = 0.01), and in ring3 from
3.1 to 5.7 nv/deg2 (p = 0.02). P1 implicit times improved in ring1 from 44.2 to 32.4 ms (p = 0.01), in ring2 from 45.2 to
33.2 ms (p = 0.02), and in ring3 from 41.9 to 32.4 ms (p = 0.01). The mean amplitude improved in 16 Tds from 2.4 to 5.0
nv/deg2 (p = 0.01) and in 32 Tds from 2.4 to 4.8 nv/deg2 (p = 0.01) in the full-field flicker electroretinography results.
Full field flicker electroretinography mean implicit time also improved in 16 Tds from 43.3 to 37.9 ms (p = 0.01). No
ocular or systemic adverse events related to the two types of surgical methods and/or Wharton’s jelly derived
mesenchymal stem cells itself were observed during the follow-up period.
Conclusion: RP is a genetic disorder that can result in blindness with outer retinal degeneration. Regardless of the type of
genetic mutation, sub-tenon Wharton’s jelly derived mesenchymal stem cell administration appears to be an effective and
safe option. There are no serious adverse events or ophthalmic / systemic side effects for 6 months follow-up. Although the
long-term adverse effects are still unknown, as an extraocular approach, subtenon implantation of the stem cells seems to
be a reasonable way to avoid the devastating side effects of intravitreal/submacular injection. Further studies that include
long-term follow-up are needed to determine the duration of efficacy and the frequency of application.
Trial registration: SHGM56733164. Redistered 28 January 2019 https://shgm.saglik.gov.tr/organ-ve-doku-naklikoordinatorlugu/56733164/203 E.507.
Keywords: Retinitis pigmentosa, Stem cell, Wharton’s jelly derived mesenchymal stem cell, Umbilical cord stem cell, Subtenon space
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好消息,感谢楼主的分享
人生贵在有追求
怎么不翻译成中文啊
人生贵在有追求
本帖最后由 风雨人家 于 2020-3-27 17:24 编辑

本文章介绍了土耳其安卡拉大学眼科医院在2019年4月至2019年10月用脐带间充质干细胞针对视网膜色素变性进行的第三期临床试验
  
  32位RP患者(34只眼)纳入研究,榫氏囊下注入间充质干细胞,治疗6个月后视力提高10.1个字母数,视野改善,外层视网膜厚度增加,多焦视网膜电图幅值增加,视网膜电图潜时缩短,未出现任何眼部和全身不良事件,证实榫氏囊下注射治疗RP是安全有效的。
  
  管理的色素性视网膜炎
  沃顿商学院的果冻派生的间充质干细胞
  细胞:初步临床结果
  艾敏OZMERT1和Umut ARSLAN2 *
  文摘
  目的:本研究的目的是确定如果脐带沃顿的果冻派生的间充质干细胞
  植入sub-tenon空间有好处在视网膜色素变性患者的视觉功能
  重新激活的退化感光细胞休眠阶段。
  材料和方法:前瞻性,非盲、三期临床试验是2019年4月之间进行的
  2019年10月在安卡拉大学医学院眼科学系。32 RP患者(34眼)
  被包括在研究。患者随访6个月后,沃顿商学院的果冻派生间充质
      干细胞管理和评估连续考试。所有患者接受了完整程序
  眼科检查,最佳矫正视力、光学素雅的断层造影,视野,
   多病灶的、细致electroretinography进行。比较的量化结果
  预先灌浆法和期末考试(6月)值。
  结果:平均最佳矫正视力为70.5字母在沃顿商学院的果冻派生的间充质干细胞
  应用程序在6月和80.6字母(p = 0.01)。视野中值偏差的平均值为27.3分贝
  在6月之前治疗和24.7 dB (p = 0.01)。外层视网膜平均厚度为100.3μm之前
  治疗和119.1μm 6月(p = 0.01)。在多病灶的electroretinography结果,P1振幅
  改善ring1从24.8到39.8 nv / deg2 (p = 0.01),从6.8到13.6 ring2 nv / deg2 (p = 0.01),而在ring3
  3.1到5.7 nv / deg2 (p =
      33.2毫秒(p = 0.02),在ring3女士从41.9到32.4 (p = 0.01)。平均振幅提高16 Tds从2.4到5.0
  nv / deg2 (p = 0.01)和32个Tds从2.4到4.8 nv / deg2 (p = 0.01)的细致的闪烁electroretinography结果。
  全磁场闪烁electroretinography平均隐式时间也改善了在16个Tds女士从43.3到37.9 (p = 0.01)。没有
  眼或全身不良事件相关的两种类型的手术方法和/或沃顿商学院的果冻
  间充质干细胞本身在随访期间观察。
  结论:RP是一种遗传性疾病,可以导致失明与外层视网膜变性。不管的类型
  基因突变,sub-tenon沃顿的间充质干细胞制成的果冻,政府似乎是一个有效的和
  安全的选择。没有严重不良事件或眼科/ 6个月符合系统性副作用
       长期负面影响仍然未知,眼外方法,subtenon植入的干细胞似乎
  是一个合理的方式,以避免毁灭性的副作用intravitreal /黄斑部注入。进一步的研究,包括
  需要长期随访来确定疗效的持续时间和频率的应用程序。
  试验注册:SHGM56733164。https://shgm.saglik.gov.tr/organ ... orlugu/56733164/203 E.507 Redistered 2019年1月28日。
  关键词:色素性视网膜炎、干细胞,沃顿商学院的果冻派生的间充质干细胞,脐带干细胞,Subtenon空间
转发
人生贵在有追求
我翻译这篇文章花了 2小时的时间,竟没有人感谢我。唉。做好事也没意思。
人生贵在有追求
翻译一篇文章是浪费精力和时间的事情。不值得。
人生贵在有追求
6# 风雨人家
值得值得,辛苦啦风雨人家大哥
感谢楼上风雨人家的翻译,也许大家对于土耳其医疗水平保持观望态度
谢谢有爱心的你的耐心的翻译。
谢谢风雨翻译。辛苦了
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