Grant Medical Center recently completed the nation's first published study of a new procedure that may give hope to millions of patients facing lower limb amputations from peripheral arterial disease (PAD). PAD is a painful circulatory problem in the legs that affects 10 million Americans. If left untreated, it can lead to serious complications such as stroke, amputation and death.
The December issue of The Journal of Vascular Surgery has published the results of a clinical trial at Grant documenting the outcomes of nine patients who received a groundbreaking transplant of adult stem cells. The study was designed to see if the stem cells would cause new blood vessels to grow bypassing severely narrowed or clogged arteries.
Six of the patients avoided major amputation through restored blood flow that eliminated their constant pain and healed their ulcerations. "We were pleasantly surprised by our results," said vascular and endovascular surgeon Randall W. Franz, MD, medical director of the Grant Vascular and Vein Center. "This is cutting-edge technology that could benefit millions of Americans with PAD."
"A total of 16 patients have now received the procedure with 13 patients avoiding major amputation," said Dr. Franz.
Dr. Franz co-authored the study with vascular surgeon Kaushal Shah, MD, and chief perfusionist Thomas Hankins, CCP. "This technique sheds new light on stem cell treatment and has the potential to become the gold-standard therapy for PAD," Hankins said.
During the procedure, surgeons extracted specialized stem cells from the patient's hip, separated them by centrifuge spinning and injected them into the arteries and muscles at the site of the blockage. "We actually grew new collateral blood vessels that restored circulation," Dr. Franz said.
Helen Thomas, 80, of Hastings, Michigan, was among the six subjects spared amputation in the study. She traveled to Grant to undergo the procedure this summer. The outcome "has been nothing short of a miracle," said Thomas, who had a non-healing leg wound and previously lost a toe due to poor circulation. "I feel like a normal person again. I'm able to go to the grocery store. Without this procedure, I would have been in a wheelchair."
Similar studies have examined the use of adult stem cells in PAD patients with limited blood flow, but Grant's was the first to investigate transplantation in patients such as Thomas, whose arteries were so severely damaged that amputation was considered the only viable treatment option.
Grant surgeons transplanted uncultured adult stem cells taken directly from the patients' hips instead of sending the cells to a laboratory for culture, a process that can postpone injection for several weeks. "We found that uncultured cells still in their natural environment worked better than cultured cells because the uncultured cells contain growth factors and other cellular elements necessary for the formation and growth of new blood vessels," Hankins said.
The minimally invasive, percutaneous procedures typically took less than an hour and required overnight hospital stays. "We were able to treat patients immediately during the procedure because we used their stem cells instead of growing them in a laboratory," Dr. Franz said. "Time was of the essence for these patients. We wanted to restore their blood flow as quickly as possible, and it can take 30 to 90 days for these cells to start growing. The faster we can treat these patients the better results they are going to have."
Out of treatment options, Thomas enrolled in the study through her orthopedic surgeon in Grand Rapids, Michigan, Kenneth Harriman, MD, who heard about it at a professional conference. She drove five hours to Columbus with her daughter Mary Burghdoff and returned home the next day. "It was easy to go through," Thomas said. "I feel very fortunate that I found out about Grant Medical Center. The long drive was a small price to pay to save my leg."