LEBANON Retired Dartmouth College professor Roger Smith said he had nothing to lose by joining a stem cell therapy clinical trial. In fact, if he didn't join, he did have something to lose possibly his leg.
In the end it appears the experiment saved his leg. And Smith, who'd already lost two toes to amputation, said he's proud to have played a part in a study that could dramatically improve the outcome for many other patients facing lower-limb amputations resulting from diabetes, high cholesterol, smoking, genetic predisposition and other causes.
The three-year study that ended last year was led by vascular surgeons at Dartmouth-Hitchcock Medical Center in Lebanon, who believe the treatment may offer new hope to sufferers of peripheral artery disease, a condition that causes nearly 60,000 lower-limb amputations every year.
Dr. Richard J. Powell, chief of vascular surgery at Dartmouth-Hitchcock, was the lead investigator of the second-phase national study, which included 72 patients from 20 different sites across the United States.
It's a winner, Powell said. For me, it was dramatic, because there has been nothing that has been shown to work. The results of the third-stage trial are to be presented to the Food and Drug Administration to be approved as a treatment for patients, Powell said.
Peripheral artery disease afflicts more than 9 million patients in the United States, according to Dartmouth-Hitchcock. The condition results from blockages in blood vessels caused by atherosclerosis hardening of the arteries. Options for these patients are limited to the insertion of stents or bypass surgery.
And for about 150,000 patients in the United States who have the most severe form of the disease, amputation is the only option. The results of this recent study suggest amputation could be prevented in the majority of these severe cases.
And if the third phase of the clinical trials confirms the earlier results, the lives of those patients with severe cases could be tremendously affected, Powell said.
This is the first potential treatment that is non-surgical for really severe cardiovascular disease in the legs, he said. Roger Smith's story
About six years ago, Smith, 79, said he was having pain in his leg and trouble sleeping. He was initially misdiagnosed as having the nerve-related condition referred to as spinal stenosis, more commonly known as sciatica. When his condition worsened, he was correctly diagnosed with advanced peripheral artery disease. He lost two of his toes to amputation and was in danger of losing his leg.
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Treatment spares Lebanon man from amputation