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Gene Therapy Shows Promise as Treatment for Diseased Limbs

New research suggests that gene therapy is a safe treatment method to explore in patients whose lower limbs are at risk for amputation because of poor// circulation caused by blocked blood vessels.

In a Phase I clinical trial, almost half the patients receiving gene therapy reported complete resolution of chronic pain one year after treatment and more than a quarter of patients with chronic wounds experienced complete healing of those ulcers in the same time frame. The results appear online and are scheduled for publication in the March 13 issue of the journal Circulation.

The researchers are the first to report on testing of the effects of the hypoxia-inducible factor-1 alpha (HIF-1a) gene as the basis of treatment for limbs damaged by compromised blood flow. Though the trial largely focused on the therapy’s safety, “the bottom line is that 34 patients improved to varying degrees with this treatment,” said Dr. Sanjay Rajagopalan, section director of vascular medicine at Ohio State University Medical Center and first author of the Circulation article.

The treatment is currently being tested in a major Phase II clinical trial in the United States and Europe.

“If this gene therapy approach were to prove safe and effective after exhaustive testing in Phase III studies, it would provide clinicians with an alternative approach to treating patients with serious blood flow problems in their lower limbs,” Rajagopalan said.

Physicians are seeking better options to treat what is called critical limb ischemia because the condition often results in amputation and is characterized by chronic wounds that resist healing. The compromised blood flow is caused by severe blockages of peripheral arteries, or peripheral arterial disease (PAD), which occurs when cholesterol or plaque builds up in the arteries outside the heart – typically in the legs or pelvis. The one-year mortality rate in patients with critical limb ischemia
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