( is between 25 percent and 45 percent a...)Gene Therapy Shows Promise as Treatment for Diseased Limbs,Health

is between 25 percent and 45 percent, and the risk of death increases with amputation.

An estimated 3 percent of Americans younger than age 60 have some degree of PAD, although they may not be aware of it because the early symptoms are often subtle. The frequency of the disorder increases with age, with more than 20 percent of individuals older than age 70 suffering from some form of it.

The current standard of care for critical limb ischemia includes the use of stents or balloons or bypass grafting to improve blood flow for patients who can tolerate such procedures. For many, these treatments offer only short-term benefits.

HIF-1a is considered a “master switch” gene produced naturally in the body that triggers the growth of blood vessel cells in patients with critical limb ischemia. The study drug, Ad2/HIF-1a/VP16, is a genetically modified form of the gene, intended to boost its active properties. The scientists theorized that HIF-1a may normalize oxygen levels in the cells by increasing interactions among multiple cytokines and genes that contribute to cell growth and facilitate survival of tissue damaged by reduced blood flow.

“Previous attempts to test gene-based formulations for critical limb ischemia have been disappointing, and that could be because the formulations tested were all single modality approaches that simply did not have the ability to induce the coordinated series of events required to induce vessel growth,” said Rajagopalan, also associate director of vascular research for Ohio State’s Davis Heart and Lung Research Institute.

He and colleagues administered the therapy through injections into the damaged limbs. The researchers completed two studies – a randomized, double-blind, placebo-controlled study, as well as an extension study in which participants, including some who had been receiving placebo, received the active treatment. Patients enrolled at five U.S. centers had at least on
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