Patients still being enrolled in clinical trial for new peripheral vascular disease treatment

The first three patients to undergo an investigational surgical procedure for peripheral vascular disease that involves the patient's own stem cells continue to do well, reports the University of Louisville surgeon who is the principal investigator.

The "TGI-PVG IDE" clinical trial initiated at UofL involves using a patient's own stem cells to line man-made bypass grafts to better the chances at saving the limbs of patients with peripheral artery disease. Charles B. Ross, M.D., chief of the Division of Vascular Surgery and Endovascular Therapeutics, is principal investigator and is joined by Marvin E. Morris, M.D., Amit J. Dwivedi, M.D. and Stuart Williams, Ph.D.

The procedure is in Phase I clinical trials and uses a new fully automated system that involves isolating the patient's own stem cells and then coating the inside of the synthetic vein graft to reduce chances of failure caused by clotting. In the new procedure, fatty tissue is harvested from each patient through liposuction. The fatty tissue is processed to concentrate vascular stem cells, which are then attached onto standard prosthetic grafts in the operating room directly at what is known as "point-of-care."

Ross said the idea of lining 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.

The procedure for isolating stem cells from fat and using these cells to coat medical devices was developed by Williams, executive and scientific director of the Cardiovascular Innovation Institute, a collaboration of UofL and Jewish Hospital & St. Mary's HealthCare. "I am so pleased to see our efforts in the laboratory, to perfect and automate this stem cell process, are now being translated to treat patients in Louisville who desperately need new technology to avoid amputations," Williams said.

"We have many more procedures to perform before this technique can be approved by the FDA, but our initial results are excellent and show great promise in helping to alleviate the pain and suffering thousands of patients experience from PVD," Ross said.