NCT01884831Unknown2 期
Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes
Ural State Medical University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- efficiency
研究概览
简要总结
In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.
During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;
- •Availability of burns II or III level;
- •Epidermolysis bullosa;
- •Availability of post-burn scars
- •Defects in the skin after surgery
排除标准
- •Acute and chronic diseases in the acute stage;
- •Autoimmune diseases of connective tissue (collagen);
- •Immunodeficiency states;
- •System of inflammatory diseases of the skin;
- •Conduct an aggressive corticosteroid therapy;
- •Acute coronary syndrome;
- •Acute disorders of cerebral circulation;
- •Availability of local inflammation in the acute stage;
- •Pregnancy;
- •Breast-feeding.
- •Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.
结局指标
主要结局
efficiency
时间窗: six weeks
次要结局
未报告次要终点
研究者
Korotkov Artem Vladimirovich
Senior Research Fellow
Ural State Medical University
研究点 (2)
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