PHILADELPHIA - Temple University Hospital's Center for Vascular Disease has initiated Phase I clinical trials to test in humans a new gene therapy that may have the potential to help the body grow new blood vessels to create a bypass around blocked leg arteries.
Temple is participating in the trial to determine the safety and tolerability of the therapy to treat patients with severe peripheral arterial occlusive disease (PAOD), or critical limb ischemia. The therapy encodes the FGF1 gene, an angiogenic growth factor. The study is sponsored by RPR Gencell, the gene therapy division of Rhône-Poulenc Rorer.
"The growth factor gene, which will be injected into the leg muscles of study participants, will be studied to document its safety and, secondarily, its ability to cause the formation of new blood vessels in limbs with blocked arteries," says Dr. Anthony J. Comerota, section chief of vascular surgery at Temple, director of the Center for Vascular Disease and lead investigator of the study.
According to Comerota, if new vessels are formed, they may create a natural bypass around blocked arteries in patients who have no other alternative for restoring circulation to their leg, and are facing a high risk for amputation. Investigators hope that the additional blood flow will reduce pain and numbness, heal wounds, and restore damaged tissue on the feet and legs.
People who suffer from severe PAOD of the legs often experience severe pain even while at rest as well as chronic wounds that won't heal, numbness, a burning sensation in their lower limbs, and gangrene that can lead to amputation. Traditionally, physicians attempt to treat these patients with surgical bypass/revascularization and angioplasty. In many cases, however, these procedures cannot be applied. Drug therapy is also ineffective for severe PAOD. Amputation of the lower leg is often the only solution for a large number of patients.