Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cell transplantation related side effect
研究概览
简要总结
This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells transplantation in diabetic patients with lower limb ischemia.
详细描述
Diabetic lower limb ischemia as severe complication of diabetes influences the life quality of patients and currently the effective treatment for the disease is lacking. Bone marrow mononuclear cells have been proved to have multiple functions including the differentiation and proliferation. In animal model, bone marrow mononuclear cells could induce angiogenesis and may have therapeutic usage for ischemia disease. The investigators thereby design the study to investigate the possible therapy of diabetic lower limb ischemia with autologous bone marrow mononuclear cells. Patient with diabetic lower limb ischemia was treated with colony stimulating factor for improvement of bone marrow hematopoiesis. Then bone marrow was taken and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection. The investigators investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, routine analysis of blood and urine etc. post the transplantation. And the efficacy was evaluated with the measurement of ulcer size, rest pain score, cold sensation score, resting ABI, resting TcPO2, collateral vessel score and skin microcirculation.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fontaine's stage 2-4 or resting ABI <0.7
- •age between 20 and 80 years old
- •sign informed consent, voluntary subjects
- •diagnosis of diabetic lower limb ischemia
排除标准
- •poorly controlled diabetes (HBA1c> 7.0%) and proliferative retinopathy (III-IV stage)
- •malignancy history in the past five years or serum level of tumor markers elevated more than doubled
- •severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate bone marrow mononuclear cells transplantation
- •serious infections (such as cellulitis, osteomyelitis, etc.)
- •pregnant female, or reproductive age female who wants to give birth throughout the course of the study
- •life expectancy less than half a year
结局指标
主要结局
Cell transplantation related side effect
时间窗: 2 week after cell transplantation
Temperature,pulse,respiration,blood pressure,routine analysis of blood and urine, liver function,renal function,function of coagulation, ECG,cell transplantation related death and cell transplantation related unexpected amputation
次要结局
- Collateral vessel score(Post cell transplantation: 1,3, 6 months)
- Skin microcirculation measurement(1,3,6 months post cell transplantation)
- Resting ABI(Post cell transplantation: 1,3, 6 months)
- rest pain score(Post cell transplantation: 1,3, 6 months)
- cold sensation score(Post cell transplantation: 1,3, 6 months)
- ulcer size(Post cell transplantation: 1, 3, 6 months)
- Resting TcPO2 (mmHg)(Post cell transplantation:1, 3, 6 months)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University