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Tissue Genesis Begins FDA-Approved Clinical Trial
Date:4/19/2011

HONOLULU, April 19, 2011 /PRNewswire/ -- Tissue Genesis, Inc., an emerging leader in adult stem cell and regenerative medicine, announced today that it has begun clinical trials for peripheral vascular disease (PVD) with adipose (fat) derived adult stem cell-coated vascular grafts at the University of Louisville Hospital.  Tissue Genesis is the first to initiate a FDA-approved trial using the patient's own adipose-derived adult stem cells (ASCs) prepared at the point-of-care.  The clinical trial commenced enrollment in April and is led by Dr. Charles B. Ross, a board-certified vascular surgeon and Chief of the Division of Vascular Surgery and Endovascular Therapeutics at the University of Louisville Hospital.

Peripheral vascular disease affects over eight million people in the United States.  By 2020, the number is expected to increase by 43 percent.  PVD includes damage to or blockage in the blood vessels of the peripheral arteries and veins, causing pain and weakness.  Approximately 25 percent of patients progress to critical limb ischemia (CLI), oftentimes leading to amputation In the United States, 130,000 amputations are performed annually due to PVD.

Researchers have been actively seeking a way to coat the inside of synthetic grafts used to treat PVD so that 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 vascular grafts.  "Based on previous studies, the potential of ASCs to increase the patency and life of the graft is tremendous," states Dr. Stuart Williams, Chief Science Officer for Tissue Genesis and Executive and Scientific Director of the Cardiovascular Innovation Institute in Louisville, Kentucky.

ASCs are being increasingly looked to as a readily available source abundant in adult stem cells.  Compared to bone marrow de
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SOURCE Tissue Genesis, Inc.
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