Researchers at the University of California at Davis have begun a study to see if patients’ own adult stem cells can be used to increase lower leg blood circulation and possibly prevent amputation due to arterial disease or diabetes.
About 85,000 leg amputations occur each year in the United States as a result of arterial disease. The condition that causes arterial disease, atherosclerosis, occurs when a build-up of fat, plaque, and calcium hardens arterial walls and greatly reduces blood flow to the legs and feet.
Common therapies include forcing arteries open with balloons, reinforcing them with stents, or bypassing them with grafts. But those approaches don’t always work, opening patients to the possibility of amputation as a final therapy.
If a way could be found to use patients’ own stem cells-which would not cause an autoimmune reaction-to form new blood vessels, it would be possible to bypass damaged vessels and reinvigorate blood flow to the lower extremities.
The UC Davis study will perform a surgical procedure that extracts bone marrow from a patient’s pelvis, then spins it in a centrifuge to separate out cell material that includes endothelial progenitor cells-the stem cells that form a person’s blood vessels in the womb. The cells will then be injected at various points along a damaged leg that is at risk for amputation.
The hope is that the procedure will result in new, healthy blood vessels. Study subjects will return to UC Davis five times in the year after they undergo the procedure.
The trial sponsor is Biomet Biologics of Warsaw, Indiana, which manufactures the specialized equipment, called MarrowStimTM, that the study will use to extract blood cells from bone marrow, as well as the centrifuge that separates and concentrates the cellular material.