A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Area of diabetic foot ulcers
研究概览
简要总结
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
详细描述
Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus Type 2 or Type 1
- •Age between 18-80 years
- •Chronic foot ulcer more than 6 weeks
- •No sufficient response to best standard care delivered for six weeks.
- •PAD up to Fontaine stage III or IV period
- •CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg
排除标准
- •HbA1c >12%
- •Hemoglobin <10 mg/dl
- •Creatinine clearance rate <30ml/min
- •Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
- •Have accepted the treatment of stem cells or growth factors
- •Have a history of malignant disease
- •Pregnancy
- •Mental illness history
- •Abnormal coagulation function
- •Allergic reaction
- •Severe cardiac insufficiency (III-IV NYHA)
- •Using vasoactive substances
研究组 & 干预措施
Autologous Bone Marrow Stem Cell
Mesenchymal stem cells derived from bone marrow infusion
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
Area of diabetic foot ulcers
时间窗: 3 months
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
次要结局
- Improvement of transcutaneous oxygen partial pressure (TcPO2)(3 months)
- Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)(3 months)
- Pain (Visual-Analog Scale)(3 months)
- Walking distance (treadmill) if possible(3 months)
研究者
Jie Shen
doctor
The Third Affiliated Hospital of Southern Medical University