Dr. Charles Ross, Chief, Division of Vascular Surgery and Endovascular Therapeutics, is the Principal Investigator of a new clinical trial for Peripheral Vascular Disease (PVD) using adipose (fat) adult stem cell-coated vascular grafts. Drs. Amit J. Dwivedi, Marvin E. Morris, and Andrea Yancey also are participating and actively enrolling subjects.

The trial, sponsored by Tissue Genesis, Inc., is the first FDA-approved trial using patients' own adipose-derived adult stem cells (ASCs) at the point of care. These were developed by Stuart Williams, Ph.D, Chief Science Officer for Tissue Genesis and Executive and Scientific Director of the Cardiovascular Innovation Institute.

PVD affects more than 8 to 12 million people in the United States. PVD includes damage to or blockage of blood vessels in peripheral arteries and veins, causing pain and weakness.

Researchers have been actively seeking a way to coat the inside of synthetic grafts used to treat PVD, so they more closely resemble native vessels and increase long-term graft survival. The stromal vascular fraction of adipose tissue contains millions of regenerative cells, which can be used to coat the inner surface of the vascular grafts.

Ross explained the idea of coating man-made grafts with stem cells to enhance long-term results is not new. What is revolutionary, however, is taking the process out of the lab and into the operating room where it can be safely and efficiently accomplished in a single procedure. This ultimately could make the technology available in any hospital where vascular bypasses are performed, he said.

Based on the previous studies, the potential of ASCs to increase the patency and life of the graft is tremendous, said Dr. Williams.

The trial commenced in April and is accepting new patients. To learn more, please contact charles.ross@louisville.edu.