1EDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to' Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
;TUDY NUMBER: 
CONTINUATION: pageJLof JL pages. 
and save a fraction of your blood containing stem cells, and 
continuously return red blood cells, platelets, and plasma to you 
through the second lumen of your central line. Apheresis has very 
few side effects, but some patients experience light-headedness, 
nausea, or tingling in the fingers and toes. These symptoms can be 
corrected by slowing down the blood flow through the apheresis 
machine. The G-CSF will- be discontinued on day 7. Repeated 
apheresis can make patients anemic. We will follow your blood 
counts carefully, and discontinue apheresis procedures before you 
become anemic enough to require transfusion, but there is a very 
small possibility that you could require a blood transfusion as a 
result of this protocol. You will not be entered into this protocol 
if you are already severely anemic. 
Stem Cell Purification: The cells collected by apheresis will be 
further purified after harvest in the laboratory by a procedure 
called "CD34 selection." The cells will be exposed to an antibody 
(protein) that sticks specifically to the surface of immature 
cells. The cells will then be run through a special column that 
separates the immature cells coated with antibody from the more 
mature cells. This antibody and column procedure is experimental, 
but has been safely used to purify stem cells from the bone marrow 
and blood of over 50 patients without any known side effects. 
Gene Transfer: The purified stem cells will be treated in the 
laboratory for 3-4 days in the presence of a "vector" designed to 
place the GC gene in the cells' genetic material (chromosomes). 
Once the GC gene is in the cell, it is permanent, and the cell will 
pass the GC gene onto all daughter cells derived from, that cell. 
The vector is a mouse virus which has been altered so it cannot 
reproduce itself. No side effects have been seen in over 50 
patients that have received cells treated with this type of vector, 
although no patients prior to this study have received cells 
treated with the GC vector. 
This is a very new procedure, and there may be risks that have not 
yet been discovered. Theoretically, there may be an increased risk 
of cancer in cells treated with vectors , however , this risk is 
minimized by making sure that the vector used can not reproduce 
itself once it is inside patient cells. Animals and -patients 
receiving cells treated with this type of v. ctor have not developed 
new cancers attributable to the vector. 
Your cells will be grown in several growth factors called IL-3, IL- 
riENT identification CONTINUATION SHEET for either: 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 1' NIH ' 2514 ' 2 (1<W4) P ^B2ff° 0 " 
