Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 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 trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound
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 adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:
- the ability of MSCs to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).
In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trophic Ulcers
排除标准
- •diagnosed cancer
- •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
MSC injection related adverse events assessed by blood count and function tests
次要结局
未报告次要终点