NCT02304588Unknown1 期
Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.
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
- 30 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the age of 30-78 years old, men and women there is no limit.
- •in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
- •with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
- •treatment on a voluntary basis, and sign the informed consent.
排除标准
- •with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
- •clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
- •the prodrome of acute infectious diseases.
- •participated in clinical subjects within three months before test.
- •adherence is poor, can not complete the course.
研究组 & 干预措施
Mesenchymal stem cells
Experimental
Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).
干预措施: Mesenchymal stem cells (Biological)
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
Academician
Chinese PLA General Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot UlcersStem Cell TransplantNCT03259217Assiut University40
已完成
1 期
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial IschemiaCoronary Heart DiseaseMyocardial IschemiaNCT00260338Rigshospitalet, Denmark31
招募中
2 期
Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosisSystemic scleroderma10003816sclerodermaNL-OMON47582niversitair Medisch Centrum Utrecht20
Unknown
不适用
Autologous Endothelial Progenitor Cells Treatment of Diabetic FootDiabetic FootNCT02474381Shanghai 10th People's Hospital60
Unknown
不适用
Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart FailureIschemic Heart FailureNCT01709279Kanazawa University6