Arteriogenesis: lessons learned from clinical trials.

Arteriogenesis is a naturally occurring process leading to formation of the true bypass collaterals capable of providing normal blood flow to the distal vascular bed. Promoting the development of such conductance blood vessels appears to be the most attractive therapeutic strategy in occlusive atherosclerotic disease. Although our understanding of molecular events regulating the blood vessel formation in adult organs is far from complete, there is a body of knowledge that allowed for planning and conduction of the early phase I and II clinical trials of therapeutic angiogenesis. Substantial human safety data, as well as important considerations of the growth factor formulation, delivery and duration of action have emerged from these trials. The current review focuses on lessons learned from double-blind, randomized Phase II trials of arteriogenesis.