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首页> 外文期刊>Journal of dermatological science >A single-arm open-label clinical trial of autologous epidermal cell transplantation for stable vitiligo: A 30-month follow-up
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A single-arm open-label clinical trial of autologous epidermal cell transplantation for stable vitiligo: A 30-month follow-up

机译：用于稳定白癜风的自体表皮细胞移植的单臂开放标签临床试验：30个月的随访

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摘要

Highlights ? The largest trial on cell therapy in vitiligo (1060 patches in 300 patients). ? Intralesional injection is proposed for epidermal cell delivery in stable vitiligo. ? It is safer, more tolerable, and less expensive than current techniques. ? It could be effective in stable vitiligo, especially for patches on face and neck. ? Long-term follow-up showed repigmentation stability in most treated patches. Abstract Background Recently, we introduced intralesional injection of autologous epidermal cells as a safe and feasible approach for transplantation in patients with stable vitiligo. This approach resulted in less pain during and after the procedure, no scarring or cobblestone formation at the recipient site, and was more feasible to perform on curved surfaces such as joints, lips, eyelids, ears, and face. Objective In this study, we aimed to investigate the long-term efficacy and safety of this transplantation technique. Methods In this open-label and single-arm clinical trial, we enrolled 300 patients with stable vitiligo. We obtained a partial thickness normo-pigmented skin specimen from the patients’ thigh-buttock junction with an area of one tenth to one third of the recipient site area. The epidermal cell suspension was prepared by processing the autologous skin specimen. We injected the cell suspension into 1060 vitiligo patches in 300 patients. Patients did not use any adjuvant phototherapy during the study. An experienced dermatologist and patients respectively defined the repigmentation score and self-assessment score at regular follow-up visits for up to 30 months after treatment. The scores represented the repigmentation percentage as follows: 0 (0), I (1%–24%), II (25%–49%), III (50%–74%), and IV (75%–100%). Results The mean repigmentation score at 3 months post-transplantation was 1.12±0.73. A significant upward trend existed in the mean repigmentation score until 9 months after cell transplantation, when the mean repigmentation score reached to 1.98±1.20. At 9 months after treatment, repigmentation of >50% was obtained in 32.2% of treated patches. Acquired repigmentation remained stable in 79.3% of treated patches during the follow-up period. The number of received cells per cm 2 positively influenced the repigmentation score. Patches located on face, neck and trunk showed significantly higher response to the treatment. Conclusion The results of our study demonstrated efficacy and safety of autologus epidermal cell transplantation on repigmentation of vitiligo patches. The achieved repigmentation was stable in the majority of treated patches during the follow-up period.
机译：强调 ？白癜风中最大的细胞疗法试验（300例患者1060次）。还在稳定的白癜风中提出了对表皮细胞递送的内部注射。还它比当前技术更安全，更容忍，更便宜。还它可以在稳定的白癜风中有效，特别是对于面部和颈部的斑块。还长期随访显示大多数治疗补丁中的重建稳定性。摘要背景近期，我们引入了稳定的白癜风患者移植的安全性表皮细胞的内腔内注射，介绍了一种安全可行的方法。在程序期间和之后，这种方法较少，在接受者网站上没有疤痕或鹅卵石形成，并且更加可行，可以在弯曲的表面上进行，例如关节，嘴唇，眼睑，耳朵和面部。目的在这项研究中，我们旨在调查这种移植技术的长期疗效和安全性。方法在该开​​放标签和单臂临床试验中，我们注册了300名稳定的白癜风患者。我们从患者的大腿臀部连接点获得了一部分厚度常规色素皮肤样品，面积为收件人区的面积为十分之三。通过加工自体皮肤样品制备表皮细胞悬浮液。我们将细胞悬浮液注入300名患者中的1060个白癜风斑块。患者在研究期间没有使用任何佐剂光疗法。经验丰富的皮肤科医生和患者分别在治疗后的定期随访期间定期定义了重建评分和自我评估评分。该评分表示重建百分比如下：0（0），I（1％-24％），II（25％-49％），III（50％-74％）和IV（75％-100％） 。结果移植后3个月的平均重新成绩得分为1.12±0.73。在细胞移植后9个月内，平均重新成绩得分的显着上升趋势存在于12个月后，当平均重建得分达到1.98±1.20。在治疗后9个月，在32.2％的处理贴片中获得> 50％的重新衰减。在随访期间，获得的重建仍然在79.3％的治疗补丁中保持稳定。每平方公里2的接收单元的数量积极影响重建分数。位于脸部，颈部和躯干上的贴片表现出对治疗的响应显着更高。结论我们的研究结果证明了自闭症表皮细胞移植对白癜风斑块复兴的疗效和安全性。在随访期间，在大多数治疗补丁中，所取得的成功稳定。

著录项

  • 来源
    《Journal of dermatological science》 |2018年第1期|共8页
  • 作者

    Zahra Orouji; Amir Bajouri; Mahshid Ghasemi; Parvaneh Mohammadi; Nasrin Fallah; Atefeh Shahbazi; Mohammad Rezvani; Fatemeh Vaezirad; Zahra Khalajasadi; Ahad Alizadeh; Ehsan Taghiabadi; Sara Dashtbozorgi; Raheleh Aghdami; Seyedeh Esmat Hosseini; Hossein Bahahrvand; Saeed Shafieyan; Nasser Aghdami;

  • 作者单位

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Epidemiology and Reproductive Health Reproductive Epidemiology Research Center;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

    Department of Regenerative Medicine Cell Science Research Center Royan Institute for Stem Cell;

  • 收录信息
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 皮肤病学与性病学;
  • 关键词

    Cell therapy; Cell transplantation; Clinical trial; Regenerative medicine; Vitiligo; Melanocyte;

    机译：细胞疗法;细胞移植;临床试验;再生医学;白癜风;melanocyte;

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