Holy Name Press Releases

Holy Name Medical Center Enrolls first US Patient in Ground-Breaking Gene Therapy Clinical Trial

Therapy may help patients with Advanced Peripheral Artery Disease Grow New Blood Vessels - Heal Wounds and Prevent Limb Amputations

February 4, 2016

Holy Name Medical Center is the first hospital in the United States to participate in a groundbreaking clinical study, called STOP-PAD, which may help prevent patients from needing limb amputations by growing tiny blood vessels. Holy Name's patient, an 81-year-old man with advanced peripheral artery disease (PAD), is the first person in the country to be treated with JVS-100, a gene therapy that activates natural repair processes in the body.

"Holy Name is one of the few hospitals in the nation with a specialized team of doctors that provides some of the world's most effective treatments for non-healing wounds and ground-breaking studies to prevent patients from needing limb amputations," said Michael Maron, President and CEO of Holy Name. "We're pleased to offer this new therapy through Holy Name's Institute for Clinical Research."

PAD is a narrowing of the arteries to the legs, stomach, arms and head due to a build-up of plaque. The disruption or complete stoppage of blood flow causes a number of symptoms and can eventually be life-threatening. Among some of the symptoms is the inability of wounds to heal because oxygen-rich blood needed for the repair process is blocked from reaching the lesion.

Holy Name's interventional radiologists, led by John Rundback, MD, Medical Director of the Interventional Institute, perform minimally invasive procedures that clear vascular paths and help repair circulation. Dr. Rundback performed one of these artery-opening procedures on the patient's leg before injecting JVS-100 near the site of a wound that wasn't healing. The patient will receive another injection in three months. A second participant in the study may receive JVS-100 within the next two weeks.

"We are excited to be part of the STOP-PAD study and to have enrolled the first patient in this ground-breaking trial," Dr. Rundback said. "The use of an advanced biologic is an exciting and innovative step forward in the field and may establish a new standard of care for treating diabetic and other patients with difficult and leg-threatening vascular wounds who otherwise face the possibility of major amputation."

The biopharmaceutical JVS-100, made by Juventas Therapeutics, is designed for patients with PAD that affects their legs. It helps the body build tiny vessels for the blood to travel, a process that occurs naturally in most people without artery disease. It is injected into the area immediately following an outpatient minimally-invasive procedure that helps open the arteries. The combination of clearing out these blood vessels plus the injected therapy should bring blood to the extremities, which would then heal the wound. Results are usually seen in several weeks to months.

This clinical trial, which will eventually involve 120 patients at 25 leading clinical centers and has been given Fast Track designation by the FDA, follows a previous study with 180 patients. In that trial, a majority of patients experienced less pain, a reduction in ulcer size and an improvement in their overall feeling of wellness, according to Joseph Pastore, Senior Vice President of Juventas. Patients reported no significant side-effects except some temporary soreness at the injection sites.

"In addition to the STOP-PAD study, a number of clinical trials are available to patients at Holy Name, offering innovative treatments that are not yet available commercially," said Ravit Barkama, MD, Assistant Vice President of Clinical Development. "JVS-100 is a perfect example - you can't get this anywhere else and it has been shown to help patients with severe cardiovascular disease."