NOT VALID WITHOUT INSTITUTIONAL REVIEW BOARD APPROVAL 
Page 2 of 5 ST. ELIZABETH'S MEDICAL CENTER 
INFORMED CONSENT 
FOR 
EXPERIMENTAL PROCEDURES IRB Approval 
Stamp 
I understand that this approach is highly experimental: it has not been previously tested 
in humans, there is no proof that it will be successful, and, likewise, there is no guarantee of its 
safety. 
At each treatment, I will report any signs or symptoms I have had since my last visit. I 
will keep a daily record of my use of any pain medications. 
I understand that I may not use any medication during the study without first checking 
with my vascular doctor. This includes over-the-counter products as well as prescription 
medication. 
I understand that because of unknown potential consequences of gene therapy to a 
fetus/child, my participation is contingent upon the fact that I no longer am capable of 
childbearing; or in the event that I am still capable of childbearing, will use some form of 
barrier contraception for a period of 3 months following gene transfer. 
2. The expected duration of the subjects participation in this study is up to 24 months. I 
understand that although my vascular doctor (Dr.Isner) intends to continue to follow me as a 
patient with regard to my vascular disease indefinitely, the duration of systematic testing 
prescribed by the current protocol is limited to a period of 24 months. The detailed description of 
the studies and their frequency has been made available to me, including the need for several 
diagnostic angiograms. 
3. Possible discomforts or risks have been pointed out to me, including, but not limited to, the 
following: 
a. pain and bruising at the site of catheter entry (arterial puncture) in the groin 
b. complications related to the catheterization such as rupture of an artery, infection, 
embolization (breaking off a piece of organized blood clot in the vessel), allergic reactions to 
the contrast media (dye) used to position the catheter, and exacerbataion of renal insufficiency. 
c. even though the DNA to be transferred to the arterial wall is considered to be 
harmless, events could occur within normal cells that take up the foreign DNA that allow them 
to be cancerous. Laboratory studies suggest that this is unlikely. Because this is a new 
procedure, however, I understand that it is not known whether cells could become abnormal 
after long periods of time. In animal studies, I am told, there is no evidence to date that such 
changes occur. 
Moreover, I understand that VEGF is known to be made by tumors, presumably to 
develop a blood supply that will allow the tumor to grow further. Although an extensive 
examination will be performed to exclude the possibility of a previously unrecognized 
cancerous growth, I understand that a microscopic growth could be present that might be 
missed by this battery of screening tests, and it is possible that the VEGF which will be made 
by the DNA which I will receive could possibly promote the development of a tumor that is 
currently too small to be recognized. 
d. it is also possible that VEGF may aggravate deteriorating eyesight due to diabetes 
mellitus, although I understand that my eyes will be checked for evidence of this problem 
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