Raw Materials and Processing Issues in the Development of Vascugel, a Cell Therapy for Vascular Disease

Vascular arterial disease is the most common cause of death in the United States. Cardiovascular surgery such as coronary artery bypass graft surgery and therapies such as angioplasty and stenting are the current standard of care. However, a large number of these procedures fail due to a form of arterial disease known as restenosis. Restenosis is the re-narrowing of the treated blood vessel following vessel wall injury resulting in decreased blood flow. This re-narrowing occurs in large part because the smooth muscle cells in the wall of the vessel proliferate after the vessel is damaged. This proliferation occurs because the endothelial cells lining the inside of the vessel, which normally control proliferation, are damaged and can no longer provide the physiological function of keeping the underlying smooth muscle cells in a steady state. Of the approximately 1.5 million procedures per year, over 500,000 are coronary artery bypass graft surgeries (1996 and 1998 data from Medical Data International). Coronary artery bypass grafts experience restenosis at a 12 to 20% rate after one year.