First human use of an allogeneic tissue-engineered vascular graft for hemodialysis access.

An arteriovenous fistula is the current gold standard for chronic hemodialysis access. Tunneled catheters or synthetic grafts have poorer outcomes and much higher risks of infection. This report presents the first clinical use of a completely biological, allogeneic, nonliving, and human tissue-engineered vascular graft. Tissue-engineered vascular grafts built from allogeneic fibroblasts were implanted as shunts in three hemodialysis patients. The tissue-engineered vascular graft was stored for 9 months, without loss of mechanical strength. Implanted grafts showed no signs of degradation or dilation, with time points up to 11 months. Results of panel-reactive antibody and cross-reactivity tests showed no evidence of immune responses.