Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
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 tropic ulcers cured
研究概览
简要总结
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts
详细描述
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.
The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
- the ability of fibroblasts to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.
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
- 否
入选标准
- •Trophic Ulcers
- •Chronic non-healing wounds
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 tropic ulcers cured
时间窗: 1 month
Number of patients cured
Number of patients with treatment-related adverse events
时间窗: 4 weeks
Fibroblasts injection related adverse events assessed by blood count and function tests
次要结局
未报告次要终点