MEDICAL 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 
STUDY NUMBER: 
CasmNLLMX^N; psge. 
2 
.pages. 
your lymphocyles removed from the blood by a procedure called lymphapheresis. This will be 
performed in the Apheresis Unit of the NIH Blood Bank. During lymphapheresis, white blood cells 
are separated from the other constituents of blood. Blood flows out of your body via a catheter (a 
small plastic tube), which is usually inserted into an arm vein, and is separated into blood fractions 
using centrifugal force either manually or through a machine. The plasma (fluid component of 
blood) and red blood cells are returned to you via either the same or a second catheter, while the 
white blood cells are removed to be infused into your twin later. The procedure may take from 1 to 4 
hours. 
f 
The lymphocytes removed by lymphapheresis will then be separated into CDS (T8) cells and grown 
separately in the lab. After 1 to 4 days, a new gene will be introduced into the cells. The process 
involved in introducing the new gene is accomplished by first inserting the gene into a vector (i.e., 
an organism that carries material from one cell to another). The vector to be used in this study is 
prepared from a disabled mouse retrovirus -- that is, a virus that is not able to reproduce, and that 
normally infects only mice. The vector is mixed with the cells in the laboratory, enters the cells, and 
inserts the new gene into the cells' genetic material (chromosomes). Once inserted, the new gene 
will survive as long as the cell survives. The new gene that will be used will direct your lymphocytes'* 
to kill HIV infected cells in your twins body. In this way, the total viral burden may be reduced. 
After the lymphocytes are marked with the new genes, they will be expanded in cell cultures up to 
approximately 1,000 times the original number of cells obtained. The time required to achieve these 
numbers of cells is approximately 3 weeks from the time you undergo lymphapheresis. Once the 
desired numbers of cells have been attained, some of the cells will be infused into your twin and 
some will be frozen for infusion at a later time. Your twin will come to the NIH Clinical Center to 
receive these cells by Intravenous infusion. We plan to repeat the infusion process approximately 
every 8 weeks for up to 7 cell infusions. We plan to perform a single lymphapheresis at the 
beginning of the study and to freeze these cells for later expansion and gene modification. 
However, if complications arise (for example, contamination of the cells) and we decide not to work 
with these frozen cells, we may ask you to agree to additional lymphaphereses. We would not 
expect this to result in more than 2 or at most 3 separate lymphapheresis sessions for this study 
POTENTIAL RISKS 
Complications of lymphapheresis include pain and bleeding at the catheter puncture site, fainting, 
temporary numbness and tingling, and machine malfunction. The most common form of machine 
malfunction is a leak or crack in the tubing through which the blood circulates. The risk of such an 
occurrence in our blood bank is 1 in 1,000 lymphapheresis sessions. Should this happen, you may 
lose as much as 1 unit (250 ml) of whole blood. One unit of blood is the standard amount taken 
during a blood donation. 
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