INDIANAPOLIS — Researchers at Indiana University School of Medicine are part of a select network assessing the potential benefits of injecting special stem cells to treat peripheral artery disease.
Michael P. Murphy, M.D., and Keith L. March, M.D., Ph.D., are enrolling patients in the Patients With Intermittent Claudication Injected With ALDH Bright Cells clinical trial, known as PACE. The study is being conducted by the National Institutes of Health Cardiovascular Cell Therapy Research Network, a group of key stem cell centers in the United States with expertise in conducting clinical trials to evaluate new treatments for cardiovascular diseases.
“The unique thing about this clinical study is the use of a stem cell population from the patient’s own bone marrow,” said Dr. Murphy, the study’s principal investigator and an associate professor of surgery at the IU School of Medicine.
The one-year study, which began in June, anticipates enrolling 80 patients nationwide who have peripheral arterial disease with intermittent claudication. Claudication is characterized by limping from pain and cramping in the lower leg due to inadequate blood flow to the muscles.
Peripheral artery disease is caused by atherosclerosis, the hardening of cholesterol plaques in the arteries. Patients with peripheral artery disease are at increased risk for heart attacks and strokes. The PACE study will review the outcomes of individuals treated with their own cells and individuals treated with a placebo.
Stem cells are extracted from the patient’s own bone marrow, thus reducing the chance for medical complications. A specific group of bone marrow cells called aldehyde dehydrogenase-bright cells respond to damage signals and may play an important role in tissue repair, said Dr. March, a professor of medicine and director of the Indiana Center for Vascular Biology and Medicine.
The purpose of the study is to see whether the stem cells can be placed safely via intramuscular injections into the affected calf and lower thigh muscles and improve blood flow and the patient’s ability to walk painlessly.
For additional information, contact Pat G’Sell at the IU Center for Vascular and Stem Cell Therapy at 855-333-3260 or pgsell@iu.edu.