A comparison of the effect of autologous bone marrow-derived mononuclear cell therapy with standard treatment on ischemia parameters in diabetic patients with chronic limb-threatening ischemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)
研究概览
简要总结
The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with chronic limb-threatening ischemia (CLTI) and diabetic foot ulcers (DFU) not eligible for PTA and to verify the effect of repetitive cell therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •diabetic foot ulcers (DFU; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C-3D, Wagner 2-4 or ischemic rest pain
- •presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA
- •age 18-90 years
- •diabetes mellitus type 1 or 2
- •signed informed consent
排除标准
- •severe active deep infection of DFU
- •pregnant women – the test of pregnancy is the part of the examination before inclusion into the study
- •deep vein thrombosis less than 6 months
- •severe limb oedema that rule out intramuscular injection of cell suspension
- •severe non-treated diabetic retinopathy requiring acutely a laser therapy
- •severe haematological disease
- •diagnosed neoplastic process of any organ less than 5 years
- •expected life prognosis shorter than 6 months
- •contracindication of general anestesia
- •females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.
结局指标
主要结局
Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)
Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)
Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival
Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival
次要结局
- Safety: adverse events - expected and unexpected
- Assesment of study treatment by patients (psychological questionaries)
- To assess the relation between the quality of cell suspension and tissue oxygenation
研究者
Michal Dubský
Scientific
Institute For Clinical And Experimental Medicine