First-in-human results of an in-body tissue architecture-induced tissue-engineered vascular graft "Biotube" for application in distal bypass for chronic limb-threatening ischemia.

Small-diameter vascular substitutes remain necessary, especially in the absence of an available autologous vein. Using a completely autologous approach termed "in-body tissue architecture," a small-diameter, long, tissue-engineered vascular graft, a "Biotube," was developed. A below-the-knee distal bypass using the Biotube as a composite with expanded polytetrafluoroethylene grafts was performed to treat a patient with chronic limb-threatening ischemia without a venous graft available. The wound on the foot had completely healed 3 months after the bypass surgery, and limb salvage and walking without claudication were achieved. At the 1-year postoperative follow-up examination, duplex ultrasound scans demonstrated graft patency without thrombus or stenosis.