Efficacy Study of Autologous Endothelial Progenitor Cells Treatment of Diabetic Foot With Infrapopliteal Arterial Stenosis/Occlusion

Study design The study was a prospective, non-random¬ized trial conducted at 2 centers in east China - Tenth People's Hospital of Tongji University and Nanjing First Hospital. The ethic committee at each center approved the protocol, and all patients provided written informed consent. All patients enrolled were assigned to CD133+ cells treatment group (CD133+ group) and control group of their own volition. This study is to evaluate the efficacy and immune-regulatory impact of intra-arterial infusion of autologous CD133+ cells on diabetic subjects with PAD.

Patient enrollment and grouping Diabetic PAD patients aged ≥18 years with Rutherford categories 2 to 5 were included to assess the eligibility for this study. All patients, who agreed to participate in the study, could voluntary choose whether or not to receive autologous CD133+ progenitor cell treatment.

In this study, CD133+cells were used to stimulate angiogenesis and reconstruct efficient microvascular blood supply, therefore similar hemodynamic status in main branch was essential to meet homogeneityin both groups before patient entry. The candidates, who failed for intraluminal revascularization of infra-aorta (iliac and femoral-popliteal)and 1 infra-popliteal (anterior/posterior tibial, fibular) arteries of the affected limb, would be excluded from the study.

Other exclusion criterion were as follows: ① Hemoglobin < 10 mg/dl, ② creatinine clearance < 30 ml/min, ③ previous history of stem/progenitor cell therapy, ④ paralysis because of central neural system disease, ⑤ accidental amputation or bone fracture of target limb because of trauma after entry, ⑥ stop of anti-platelet medication after entry, ⑦ smoking or re-smoking after entry, ⑧ malignant tumor.

Treatment of infra-aorta & infra-popliteal artery lesion Computed tomographic angiography (CTA) was performed to firstly analyze the condition of vascular lesion and then digital subtraction angiography (DSA) was performed to precisely identify the lesions of infra-aorta and the infra-popliteal arteries before treatment.