Abstract

1 First Human Use of an Allogeneic Tissue Engineered Vascular Graft Todd N. McAllister, Cytograft/St. Joseph's Translational Res Inst, Novato, CA; Wojciech Wystrychowski, Medical UNiversity of Silesia, Katowice, Poland; Lech Cierpka, Krzysztof Zagalski, Medical Univ of Silesia, Katowice, Poland; Sergio A. Garrido, Fleni Hosp, Buenos Aires, Argentina; Samuel Radochonski, Nathalie Dusserre, Cytograft, Novato, CA; Nicolas L'Heureux, Cytograft/St. Joseph's Translational Res Inst, Novato, CA Introduction: End Stage Renal Disease (ESRD) is one of the most costly chronic diseases in the industrialized world. In the U.S., more than $27 billion is expended annually for the care of 400,000 dialysis patients. Creation and maintenance of access shunts is one of the principal challenges associated with dialysis, and accounts for 15% of all ESRD-related expenses. A more effective solution to hemodialysis access remains one of the key objectives in vascular surgery today. Previously we reported promising results with the first human patients to receive a completely autologous tissue engineered vascular graft (TEVG) for hemodialysis access. With time points out to 3 years, we observed a 2.4-fold reduction in events relative to the pre-enrollment rates with the standard of care. The complexities of the autologous model, however, make it difficult to translate to widespread clinical use. We hypothesized that an allogeneic TEVG, available ‘off-the-shelf,’ would have similar benefits and may demonstrate improved efficacy and cost-effectiveness relative to synthetic grafts. Here we report the first human …

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