NCT02287831已完成1 期
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
详细描述
The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-75 years
- •Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9
- •Poor distal arterial outflow tract
- •Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
- •Poor physical condition can not tolerate surgery
- •Patients are willing to participate in the study and sign the informed consent.
排除标准
- •Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
- •Severe or acute organ damage
- •Presence of malignancy
- •Pregnancy or lactating patients
- •HIV positive
- •A history of severe allergies related cell therapy
- •Conservative treatment < 3 months
- •Acute limb ischemia
- •Local obvious infection uncontrolled
- •Alcoholics or drug abusers within a year
- •Severe psychiatric disorder.
- •Patients need surgical treatment
- •Above the ankle gangrene
- •Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
结局指标
主要结局
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
时间窗: 6 months
Amputation rate and mortality will be combined to report safty in %
次要结局
- To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.(6 months)
研究者
Pingping Huang,MD
M.D.
Institute of Hematology & Blood Diseases Hospital, China
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