ST. ELIZABETH S MEDICAL CENTER 
INFORMED CONSENT 
FOR 
EXPERIMENTAL PROCEDURES IRB Approval 
Stamp 
Title of Study or Protocol: Arterial Gene Therapy for Therapeutic Angiogenesis in Patients 
with Peripheral Artery Disease 
Name of Principal Investigator: Jeffrey M. Isner, M.D. 
Participant: 
Date: 
I have read this consent form and certify that the activity in which I am to participate involves an 
experimental procedure which has been fully described by Dr. Isner or his 
representative. The procedure(s) are described below: 
1. A fair and understanding explanation of the scope, aims, and purpose of the research or 
treatments that are experimental in nature which has been identified and includes the following: 
(Use an additional sheet of paper if necessary) 
I understand that the purpose of this clinical investigation is to determine if gene therapy 
can be used to cause the development of new blood vessels in legs with blocked arteries, and to 
further determine if the additional blood flow which is provided by such new blood vessels will 
be sufficient to eliminate leg pain present at rest ("rest pain") and/or heal ulcers in the feet and 
legs. 
I have been told that while angioplasty techniques and/or surgery may often increase 
blood flow in patients with blocked arteries sufficient to relieve rest pain and/or heal ulcers, the 
blockages in my legs are too extensive to permit either of these therapies. I am told that there are 
no medications currently available that are likely to heal ulcers or result in relief of rest pain. 
Accordingly, a new strategy, gene therapy, which has not been used previously for the treatment 
of lower extremity arterial insufficiency, is being investigated for the treatment of patients like 
myself in whom peripheral artery disease has resulted in rest pain or ulcers. This therapy has 
been tested thus far in laboratory animals; the experiments suggest that if one performs surgery 
on the animal (rabbit) to create blockages in the leg arteries, one can use gene therapy to grow 
new blood vessels around the blockages; this treatment, I am told is termed "therapeutic 
angiogenesis." 
The treatment will involve using a catheter - similar to catheters which are used to 
perform balloon angioplasty - to deliver DNA, or genetic material, to an artery in my leg that is 
still open. The DNA is delivered to the wall of the artery from the balloon of die catheter when 
the balloon is inflated. Once in the arterial wall, the DNA then directs the cells of the artery wall 
to make a certain protein, in this case a protein called vascular endothelial growth factor (VEGF). 
VEGF is a protein which has been shown to cause new blood vessels to grow under a variety of 
conditions, including the above-described rabbit experiments in which both the protein and the 
gene for the protein caused new blood vessels to develop in the leg with arterial blockages; these 
blood vessels grew around the blockages so that blood flow was re-established to the lower limb, 
beyond the site where the blockage was created. 
My vascular doctors are thus investigating the possibilty that by using a catheter to 
transfer the gene for VEGF to the arterial circulation of a leg with blocked arteries , new blood 
vessels will develop that will reduce pain in the leg and/or heal an ulcer. 
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Recombinant DNA Research, Volume 20 
