Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety of the treatment
研究概览
简要总结
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
详细描述
It is estimated that about 150 million people are suffering diabetes mellitus, of whom more than 15% will develop foot ulcers or gangrene at some times, so called diabetic foot. The diabetic foot is very difficult to cure by traditional approaches.
This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of diabetic foot.
- •Signed informed consent before recruiting.
- •Age above 18 years or less than 90 years.
- •ECOG score < 4
- •Tolerable coagulation function or reversible coagulation disorders
- •Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR < 2.3 or PT < 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin > 28 g/L；Total bilirubin < 51 μmol/L
- •Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
排除标准
- •Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- •Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
- •Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- •Patients have poor compliance.
- •Allergic to the skin drug;
- •Any agents which could affect the absorption or pharmacokinetics of the study drugs
- •Other conditions that investigator decides not suitable for the trial.
研究组 & 干预措施
Stem Cell Derived Exome
干预措施: Skin drug prepared with exome originated from stem cell (Drug)
结局指标
主要结局
Safety of the treatment
时间窗: Six months
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Efficacy of the treatment
时间窗: Six months
Efficacy will be defined as objective response rate + steady disease rate.
次要结局
- Duration of remission (DOR)(5 years)