**5.4.2 Endothelial cell loaded gel foam wraps**

The rationale behind the use of these wraps is that the endothelial cell (in addition to lining blood vessels) is also a "bioreactor" which produces a large number of beneficial mediators that reduces thrombosis, inflammation, stenosis, and increases lumen diameter. Initial experimental studies have documented a beneficial effect of endothelial cell loaded gel-foam wraps in porcine models of AV fistula and graft stenosis 195-198. A recent Phase II study ("V-HEALTH") was able to demonstrate technical feasibility and safety in hemodialysis patients who received a "Vascugel®" wrap loaded with treated human aortic endothelial cells at the time of AVF or AVG placement 97. A phase III multi-center randomized-controlled study using the Vascugel® (Pervasis Therapeutics, Inc., Cambridge, MA) wraps in human AVGs is currently being designed.
