June 13, 2011

COLUMBUS, Ohio – A new treatment option, using a person’s own stem cells, could hold promise for some of the hundreds of thousands of patients suffering from critical limb ischemia, which blocks blood flow to the legs resulting in constant pain, ulcer formation or gangrene.

Researchers and clinicians at The Ohio State University Medical Center are leading a new trial testing the effectiveness of marrow-derived stem cell therapy for patients affected by critical limb ischemia (CLI).

“We are in the early stages of this trial, yet we believe this therapy could provide benefits to the many patients suffering from this debilitating illness,” says Dr. Michael Go, a vascular surgeon at Ohio State’s Medical Center and the study’s principal investigator, who is collaborating on the trial with Dr. Vincent Pompili, director of cardiovascular cell-based therapies at Ohio State. “Given the prevalence of CLI, there is a compelling need for limb salvage therapies beyond currently available treatments, such as risk factor modification, medical therapy and bypass surgery.”

CLI is a form of peripheral vascular disease, which affects 10 million people in the U.S. Approximately 750,000 individuals suffer from the condition. Despite the currently available treatments, many patients with CLI will die or undergo major amputation within five years. Half of the affected patients are not candidates for bypass surgery for a variety of reasons, leaving them no option other than amputation which subsequently worsens their quality of life.

According to Go, one way to increase blood flow to a limb is “collateralization,” where a patient’s own body responds to blockages in blood vessels by creating alternative new channels for blood to flow around blocked arteries. As part of the trial, doctors harvest a patient’s own vascular stem cells, which are present in high concentrations in bone marrow, and deliver them to the ischemic limb in an effort to stimulate the collateralization process.

Patients enrolled in the study will have follow up visits at one, three, six, nine and 12 month intervals to check progress against a set of specific measures. Among the initial measures is whether the patient’s pain level improves and if ulcers and gangrene begin healing.

Go says that OSU Medical Center plans to enroll 15 patients in this phase I trial, with an eventual goal to expand to a multicenter trial in the future.

“The launching of this trial is a true culmination of a highly collaborative effort combining our basic science cell therapy research team with our vascular medicine expertise,” says Dr. Thomas Ryan, director of the Ohio State University Heart and Vascular Center. “This type of ‘bench to bedside’ translational research exemplifies our mission of improving people’s lives through innovation.”

Funding for the trial is provided by The Ohio Third Frontier RCP funded awarded to Arteriocyte, Inc., a start-up company of The Ohio State University. Pompili serves at Arteriocyte’s clinical director.

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Contact: Doug Flowers, Medical Center Public Affairs and Media Relations, (614) 293-3737, or Doug.Flowers@osumc.edu

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