Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Angiographic evaluation of angiogenesis at ischemic limb
研究概览
简要总结
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
详细描述
Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus Type 2
- •Age 18 - 75 years
- •Subject has an Ankle-brachial index < 0.9
- •Subject has had previous conservative treatment which resulted in little or no improvement
- •Subject has had no stem cell treatment within the past 6 months
- •No sufficient response to best standard care delivered for six weeks.
- •No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- •Signed informed consent
- •Absence of life-threatening complications from the ischemic limb
- •Life expectancy more than 2 years
- •Negative pregnancy test when applicable
排除标准
- •Diabetic retinopathy
- •History of neoplasm or hematological disease
- •Uncontrolled high blood pressure (>180/110)
- •Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
- •Malignant ventricular arrythmia
- •Deep venous thrombosis during the last 3 months
- •Active bacterial infection
- •Body mass index > 35 Kg/m2
- •Stroke or myocardial infarction during the last 3 months
研究组 & 干预措施
umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
干预措施: umbilical cord mesenchymal stem cells (Biological)
Standard Therapy
Any therapy for diabetic foot which is routinely practiced and accepted in China
干预措施: Standard Therapy (Drug)
结局指标
主要结局
Angiographic evaluation of angiogenesis at ischemic limb
时间窗: 6 months
次要结局
- Pain(3 months)
- Ankle-Brachial pressure index(3 months)
- Wound healing (wound size, wound stage)(3 months)
- Walking distance(3 months)
- Rate and extent of amputations(6 months)