NCT04464213Unknown1 期
Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Rate of adverse event
研究概览
简要总结
This study is designated to:
- investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
- learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
- study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and Age ≤ 75
- •Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
- •Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
- •Full understand the informed consent form, and signed it voluntarily
排除标准
- •Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
- •Be allergic to any component of the drug or showed allergic constitution
- •Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
- •Have malignancy in the ulcer pathology test, or have a history of malignant tumor
- •Unable to clean the wounds due to the formation of tract between the ulcer and other condition
- •Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
- •Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr>200 μmol/L
- •Have a history of apoplexy, unstable angina pectoris, myocardial infarct
- •Have a psychiatric history, drug abuse or alcohol abuse history
- •Had participated in any other clinical trials in the past 3 months
- •Any other circumstances judged by the researchers disqualify the patient to participate in the trial
结局指标
主要结局
Rate of adverse event
时间窗: 0 Day - 7 Days
The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
次要结局
- Rate of cure rate(0 day - 34 days)
- Rate of serious adverse event(0 hour - 1 hour)
研究者
研究点 (1)
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