NCT02685722已完成1 期
Umbilical Cord Mesenchymal Stem Cells Between Gel Treatment Difficult Skin Ulcer Healing Efficacy and Safety of Random, Open, Before-and-after Study
Chinese PLA General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012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
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 78 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 17 year old male or female (pregnancy);
- •Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years of age must be signed by the guardian informed consent;
- •The process of psychological stability, can finish the tes
排除标准
- •Allergic constitution, or known allergic to pork or beef source products, gao min physique person;
- •The wound is more than 10 cm by 10 cm;
- •People with mental illness, drug abusers and or other items;
- •1 month used or are using the sugar metabolism of drugs, such as corticosteroids, thiazide diuretics, tricyclic antidepressants, etc;
- •3 month participated in other similar test;
- •Serious infectious disease not controller;
- •With surgery, such as severe trauma stress situation;
- •Always had a history of tumor;
- •Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.
结局指标
主要结局
Frequency of Adverse Events
时间窗: 6 months
Frequency and severity of Adverse Events
次要结局
- Relative Wound Area Regression of 40% or More at 6 Week(6 week)
研究者
Xiaobing Fu
Principal Investigator
Chinese PLA General Hospital
研究点 (2)
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