Northwestern Medicine has launched an investigational trial into the use of stem cells to save limbs from amputation.
A randomized group of patients with severe peripheral artery disease (PAD) will receive injections of their own stem cells to try to restore blood flow to the leg. In its most severe form, PAD causes critical limb ischemia (CLI), which can cause pain in resting legs, sores or ulcers that do not heal, thickening of the toenails and gangrene, which can eventually lead to amputation.
Patients will undergo a bone marrow extraction and the bone marrow will be loaded into the MarrowStim PAD Kit, an investigation device that separates out the stem cells. The stem cells will be injected in 40 different spots on the affected limb, delivering concentrated bone marrow in each one. The entire procedure takes about 90 minutes. Patients will follow-up with investigators at different intervals in the year following the injections.
“MarrowStim offers a new approach for patients with a grim prognosis,” Melina Kibbe, MD, vascular surgeon at Northwestern Memorial Hospital and Edward G. Elcock Professor of Surgical Research at Northwestern University Feinberg School of Medicine, stated in a press release. “We are pleased to be part of this national trial to see if there might be a significant chance of improving treatment for patients with few choices left for treatment.”
Researchers are still unsure of the reason the bone marrow injections might help chronic limb ischemia, according to Karen Ho, MD, a Northwestern Medicine vascular surgeon and assistant professor in vascular surgery at Feinberg who is also an investigator on the trial.
“Nobody really knows the exact mechanism,” Ho stated. “The idea is that it might improve or enhance new blood vessels in the calf.”
For more information about the study, visit http://www.feinberg.northwestern.edu/sites/bcvi-ctu/clinical-trials/vascular-disease.html.