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IUPUI INFORMED CONSENT STATEMENT 
for 
PROJECT Retroviral-Mediated Gene Transfer of Bone Marrow Cells During 
TITLE; Autologous Bone Marr.ow_Tx 4 nsplantatior> for A cute Leu kemia 
Page 2 
The following procedure will be used to insert the gene into my bone marrow 
cells. My bone marrow cells will be obtained by a bone marrow harvest in 
the operating room using the regular procedure for harvest. The 
investigator will not need to obtain any more bone marrow than is normally 
taken during bone marrow harvest. Therefore, there will be no additional 
needle aspirations or additional anesthesia time. The major portion of 
the harvested marrow will be handled in the usual fashion and will not be 
treated by retroviral-mediated gene transfer. A small portion of marrow 
(no more than 30%) will undergo retroviral-mediated gene transfer. The 
gene to be transferred is attached to a virus that is able to enter bone 
marrow cells and therefore takes the gene with it, The "marked" cells will 
be stored after harvest along with my untreated bone marrow cells and both 
will be given back to me at the time of bone marrow transplantation. 
I will have the standard blood drawings and tests that are required 
following bone marrow transplantation. These have all been explained to 
me. My bone marrow and blood cells will be studied in the laboratory at 
the following intervals; prior to bone marrow harvest, prior to 
transplantation, 21 days following transplantation, when my blood counts 
show that the transplant is engrafting, at 100 days following transplant 
and then once a year. A blood sample and bone marrow will be studied 
should my disease recur. Thereafter, a small amount of blood will be 
obtained for study in the laboratory every six months. Bone marrow 
biopsies and blood drawing are normally scheduled at these intervals, so 
there will be no additional bone marrow biopsies performed (nor will bone 
marrow biopsies be different in any way from what normally would be 
performed) and no additional needle sticks will be necessary for blood 
drawing because of this research study. This is merely to inform me that 
a portion of my bone marrow and blood will be analyzed for research 
purposes . 
3. I will not benefit personally by participating in this research study. 
However, future patients may benefit from the knowledge gained. 
4. No side effects have been seen in animal studies or in the very limited 
human research on gene transfer. However, since this is a very new 
procedure, the risks may not be known. There are some theoretical 
(possible) risks to this procedure. First, even though the virus used to 
insert the gene into my bone marrow cells cannot grow and is considered 
harmless, it is possible that events could occur within the cells that 
allow the virus to grow or cause the cell to become cancerous. It is also 
Patient's Initials 
[504] 
Recombinant DNA Research, Volume 15 
