Study Utilizes
Gene Therapy for Patients with Peripheral Arterial Disease
January / February 2002
Cardiologists at Penn Cardiac Care are currently conducting
a study with Pfizer, Inc. involving an experimental gene
transfer
product to examine the potential for improving the symptoms
of disabling claudication in patients with peripheral arterial
disease (PAD).
PAD results from an inadequate supply of blood and oxygen
to muscle and the usual symptom is muscle pain to the lower
legs with walking (claudication). The most common cause of
PAD is cholesterol build-up in the arteries of the lower leg.
The purpose of this study is to examine the potential for
this investigational product to create networks of new blood
vessels in the legs to bypass the vessels that are blocked
by the cholesterol build-up.
This multi-center national study represents the first trial
that will evaluate the safety and tolerance of local intramuscular
injection of AdVEGF121 (a gene for vascular endothelial growth
factor) to determine if it improves pain-free walking distance.
Therapeutic angiogenesis, the creation of new blood vessels,
is being studied in patients who are not otherwise candidates
for surgical bypass or catheter-based treatment.
"This is the first prospective, placebo-controlled study
looking at walking distance as an endpoint," says Emile
R. Mohler III, MD, the principal investigator for this
study and a vascular and peripheral medicine specialist. "We
are hoping to provide a relatively non-invasive way to improve
the lifestyle of patients with vascular disease, particularly
because there are limited medications available."
In addition, patients with PAD are at very high risk for
heart attack and stroke. In fact, each PAD patient has a 30
percent risk of dying over five years after initial diagnosis,
and the majority of deaths are cardiovascular in nature. "It
is critical for people diagnosed with PAD to see a cardiologist
not only who is able to treat the vascular disease in the
patient's legs, but is also an expert in cardiac disease,"
says Dr. Mohler.
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Referring Physicians: To speak with a Penn physician
or refer a patient, contact PennHealth through the secure online
referral form or by calling
1-800-789-PENN
(7366). |
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