Transplantation of autologous bone marrow cells in patients with no-option critical limb ischemia

ational Institute of Heart and Vascular Diseases0 个研究点目标入组 62 人开始时间: 2016年7月26日最近更新: 2017年8月28日

试验速览

暂无简介。

•1. Patients over 18 years of age
•2. With ischemic skin lesions (ulcers or gangrene) with a Critical limb ischemia Rutherford category of 5 or 6 according to the TransAtlantic InterSociety Consensus (TASC) classification (minor or major tissue loss)
•3. Critical limb ischemia defined by ankle–brachial index =0.4, or ankle systolic pressure <50 mmHg, or toe systolic pressure <30 mmHg, or transcutaneous oxygen pressure (tcpO2) <30 mmHg
•4. No option for endovascular or surgical revascularization assessed by a vascular surgeon and interventionalist
•5. Failed revascularization defined as no change of clinical status with the best standard care 4 weeks after endovascular or surgical revascularization

•1. Life expectancy <6 months
•2. Evidence of malignancy during last 5 years
•3. Proliferative retinopathy
•4. Critical coronary artery disease or unstable angina pectoris
•5. End-stage kidney disease and patient on dialysis
•6. Bone-marrow disease (e.g., myelodysplastic syndrome, severe anemia, leukopenia, thrombocytopenia)

发起方

ational Institute of Heart and Vascular Diseases