This paper reports a phase I dose-escalation clinical trial for the treatment of peripheral arterial disease (PAD) with BF30, a recombinant Sendai virus vector carrying the human native fibroblast growth factor 2 (hFGF2) gene. Our goal was to evaluate the safety and tolerability of BF30 at varying doses while assessing its preliminary therapeutic effect. Twelve male patients with PAD unsuitable for revascularization procedures that met the enrollment criteria were recruited. Each patient received a BF30 injection on one side of the ischemic lower limb. No deaths occurred prior to the 6-month follow-up. No severe adverse events or Grade 3/4 adverse events related to the BF30 injections were noted. Furthermore, the viral genome level was below the quantization limit after 6 months, and hemagglutination activity was undetectable in seven of the 12 cases. Abnormal changes in hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), and proinflammatory factor serum levels were not observed. None of the cases exhibited a positive anti-drug antibody signal. In addition, a positive therapeutic effect was demonstrated by the reduction in rest pain and Rutherford classification and improvement of the ankle-brachial index. While a higher dose triggered a stronger immune response, it was more effective in improving the Rutherford classification and quality of life.

Background Aortic involvement in patients with Behcet’s disease (BD) is rare, but it is one of the most severe manifestations. Open surgical repair of aortic aneurysm is challenging considering the high risk of postoperative recurrent anastomotic pseudoaneurysms and is associated with a much higher mortality rate. Recently, endovascular treatment has provento be a feasible, less invasive alternative to surgery for these patients. Case presentation We report a total endovascular repair of a paravisceral abdominal aortic pseudoaneurysm in a 25-year-old male patient with BD. The pseudoaneurysm was successfully excluded, and the blood supply of visceral arteries was preserved with a physician-modified three-fenestration endograft under 3D image fusion guidance. Immunosuppressive therapy was continued for 1 year postoperatively. At 18 months, the patient was asymptomatic without abdominal pain. Computed tomography angiography demonstrated the absence of pseudoaneurysm recurrence, the antegrade perfusion of visceral vessels, and the absence of stent graft fractures. Conclusions Endovascular repair using physician-modified fenestrated endografts is a relatively safe and effective approach for treating paravisceral abdominal aortic pseudoaneurysm in BD patients. Long-term immunosuppressive therapy is necessary to decrease the risk of postoperative complications and recurrences.