Tissue Engineering Society International Annual Conference, Oct. 24, 2005
First Clinical Use of Tissue Engineered Blood Vessels in the Adult Arterial Circulation
Nicolas L´Heureux, Todd McAllister, Sergio Garrido, Alicia Marini, Hernan Avila, Luis de la Fuente, Ximena Manglano, Robert C Robbins, Gerhardt Konig, Nathalie Dusserre
The historical challenge in the field of Cardiovascular Tissue Engineering has been to produce a conduit with the appropriate mechanical strength (i.e. burst pressure in excess of 1700 mmHg). To achieve the requisite strength, most approaches have relied upon permanent synthetic or xenogeneic scaffolds. These scaffolds, however, may be associated with chronic inflammation, disease transmission, or mechanical degradation that limit their clinical use. In an effort to eliminate the deleterious effects of permanent biomaterials, more recent trends have focused on either resorbable scaffolds or completely biological approaches. Previously we reported a completely biological and autologous approach termed Sheet-based Tissue Engineering (SBTE), where tubular constructs were made from rolled sheets of fibroblasts. Importantly, this approach provides the requisite mechanical strength even when using human cells extracted from adult patients with advanced cardiovascular disease. Here, we report the first clinical use of a tissue engineered blood vessel (TEBV) for adult arterial revascularization. Nine patients with end stage renal disease have been enrolled in the current study. TEBVs were assembled using fibroblasts extracted from a small dermal biopsy and endothelial cells isolated from a superficial vein at the same incision site. At least 12 vessels were built for each patient, allowing mechanical and microbiological testing prior to implantation. In all cases, vessels met criteria of burst pressure, suture retention strength, endothelial coverage, sterility, mycoplasma and endotoxin levels. The vessels (17 cm long x 4.8 mm i.d.) were implanted as a shunt between the humeral artery and the axillary vein to be used for hemodialysis access. End-to-side anastomoses were made using standard surgical techniques (interrupted sutures, 7-0 Prolene). Graft patency has been followed by Doppler ultrasound and magnetic resonance imaging. Short to mid-term follow-up from the first patients will be presented.