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U of U Seeks People With Severe Artery Disease To Study Whether Patients' Own Stem Cells Can Help Prevent Leg Loss
University selected as site in nationwide trial of experimental treatment
Jul 8, 2008 8:30 AM
People with a form of peripheral vascular disease so severe that it can lead to leg amputations might be able to use their own stem cells to remedy the problem.
The University of Utah recently was selected as a site in a nationwide trial of the experimental treatment and U of U medical researchers are looking for participants with critical limb ischemia, a severe obstruction of the arteries that feed blood to the legs, according to Larry W. Kraiss, M.D., professor and chief of vascular surgery at the School of Medicine and lead Utah investigator in the trial. To be eligible for the trial, participants must have exhausted all other treatment options, he said.
“We’re looking for patients who are not candidates for other treatments, such as angioplasty and bypass surgery,” Kraiss said. “This is a way to offer hope to people who have no other options to treat the problem.”
The nationwide trial, approved by the U.S. Food and Drug Administration, will enroll a total of 75 participants, with five of those at the University. The trial is open to patients between the ages of 21 and 80 who are not currently sick or in renal failure.
Participants will take a medication that stimulates production of white blood cells, which contain stem cells. The patient’s blood then will undergo apherisis, a process that separates stem cells from other blood cells. After that, the adult stem cells will be purified and concentrated at the University’s cell therapy lab. Patients are randomly selected to receive either one of two dosing levels of stem cells or a saltwater solution placebo. The stem cells or placebo then will be injected into muscle in areas of participants’ legs where blood flow is restricted.
“The hope is that if a stem cell is put into an environment where it recognizes the need for blood vessels, it will form new blood vessels,” Kraiss said.
Trial participants will be evaluated at and receive stem cell or placebo injections at University Health Care’s Cardiovascular Center in University Hospital. If the treatment works, Kraiss hopes to see improved circulation in patients within a couple of months after the injection and significant improvement in three to six months. Participants will be examined every two weeks for the first two months following the treatment, and then at three, six, and 12 months for a total of seven follow-up visits.
Although this type of stem cell treatment for critical limb ischemia has not been tried in people, it has worked in laboratory mice, according to Kraiss. Researchers also are conducting similar trials with people who have heart disease. If the treatment does succeed in treating critical limb ischemia, a larger trial would follow, according to Kraiss.
“There’s good evidence it may work,” he said. “Experiences in the laboratory show promise.”
Patients with critical limb ischemia often can be treated with angioplasty or bypass surgery. Angioplasty is a procedure in which balloons are inflated inside arteries to open a blockage and improve blood flow. In bypass surgery, a vein is taken from another area of the body and attached in the leg to bypass the blocked artery or vein.
Kraiss and other U of U vascular surgeons perform both angioplasty and bypass surgery. But in some patients, neither procedure sufficiently improves blood flow, so leg amputation currently is the only solution.
“The University already is a state-of-the-art referral center for limb salvage,” Kraiss said. “Now we’re offering trials for those in whom conventional treatment doesn’t work.”
He estimates 2,000 Utahns have critical limb ischemia.
Linda L. Kelley, Ph.D., associate professor of internal medicine and director of the University’s cell therapy lab, is co-principal investigator on the study.
People interested in participating in the trial can call 801-585-3663 or 1-800-824-2073 and ask for Maria.
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