U Health Sciences Center researchers hope a new stem cell study will help patients recover from an intense leg disease, which can lead to amputation if it goes unchecked.
As a professor and chief of vascular surgery at the U School of Medicine, Larry Kraiss is part of a nationwide trial to see if patients’ own stem cells will help them recover from a type of peripheral vascular disease.
U medical researchers are searching for five volunteers with a condition called critical limb ischemia-an obstruction of the arteries that feed blood to the legs.
“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 in a press release.
Kraiss said the disease occurs when plaque builds up in the leg arteries, similar to the way plaque builds up in the heart or brain, causing heart disease and strokes.
“This shuts down the blood supply, causing flesh and tissue to start to die,” he said.
In the study, volunteers will take medication to encourage the production of blood cells, which contain stem cells. The patient’s blood will then go through a process to remove the stem cells from the blood. A cell therapy lab will purify and concentrate the stem cells. Patients will then receive either a saltwater placebo or one of two dosing levels of the stem cell concentrate in areas of the legs where limited blood flow occurs.
Volunteers will have checkups every two weeks for two months and then checkups at three, six and 12 month intervals afterward. If the treatment is successful, Kraiss expects there to be improvement in the first six months.
This study, coordinated by Northwestern University, has worked with laboratory mice, but this is the first time it will be tried on humans.
“There’s evidence it will work,” Kraiss said. “I am optimistic.”
Kraiss said there might be risks in this study but that most patients would be willing to give the study a try.
“There are always risks,” he said. “It is hard to say what the risks would be. In this study we will likely find some patients willing to accept unknown risks because the other alternative is amputation.”
To qualify for the study, potential patients must meet strict requirements and be without any other treatment options, such as angioplasty or bypass surgery.
“This is a way to offer hope to people who have no other options to treat the problem,” Kraiss said in the release.
However, because of the strict requirements, none of the potential patients have qualified for the study.
“We have had a number of contacts, but have not enrolled a patient yet,” Kraiss said. “We would like to, but the restrictions of the study have been very stringent.”
Regardless, Kraiss said he is not concerned.
“It is a common thing in research studies. You have to identify the exact population that will get the best results.”
Until then, they are playing a waiting game.
“As soon as they can get volunteers, they can start the research process,” said Phil Sahm, a spokesman for the HSC.
Kraiss said that the U covers a four- to five-state area and that a potential patient does not have to live in Utah to be a part of the study.
Volunteers will be compensated nominally. Kraiss said it is intended to cover time and attendance, but is not an incentive for patient participation.