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临床试验/NCT04485962
NCT04485962已完成1 期

Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Number of patients with treatment-related adverse events

研究概览

简要总结

Treatment of patients with burns of the skin of the 2nd degree using: autologous keratinocytes and skin fibroblasts mixed with collagen gel 7% (tissue equivalent of the skin)

详细描述

Treatment of patients with burns of the skin of the 2nd degree by applying a wound covering with layer-by-layer cultured autologous keratinocytes and fibroblasts in collagen gel

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • skin burns of the 2nd degree

排除标准

  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders
  • pregnancy

结局指标

主要结局

Number of patients with treatment-related adverse events

时间窗: 1 month

Cell application related adverse events assessed by blood count, liver and function tests

Number of cured patients

时间窗: 1 month

Number of patients cured

次要结局

未报告次要终点

研究者

研究点 (2)

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