DONOR CONSENT 
PAGE 2 
CD8 cells. In this way, we will be able to monitor the survival of CD4 cells and CD8 
cells separately once they have been infused. 
After the lymphocytes are marked with the new genes, they will be expanded in 
cell cultures up to 1 ,000 times the original number of cells obtained. The time required 
to achieve these numbers of cells is approximately 10 days to 2 weeks from the time 
you undergo lymphapheresis. Once the desired numbers of cells have been attained, 
you twin will come to the NIH Clinical Center to receive these cells by intravenous 
infusion. We plan to repeat this process approximately every 6 weeks for a total of 3 
cell infusions. 
Lymphapheresis is a procedure where white blood cells are separated from the 
other constituents of blood. Blood flows out of your body via a catheter, 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 
catneter, while the white blood cells are removed to be infused in your twin later. The 
procedure may take from 1 to 4 hours. Complications of lymphapheresis include pain 
and bleeding at the catheter puncture site, fainting, temporary numbness and tingling, 
and machine malfunction. The commonest 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 1000 lymphapheresis sessions. Should this happen, you 
may lose as much as 1 unit (1 pint) of whole blood. One unit of blood is the standard 
amount taken when a normal volunteer makes a blood donation. In a previous bone 
marrow transplant study similar to this one, where 14 donors each underwent 6 
lymphaphereses sessions no significant machine malfunctions occurred. 
The potential benefit of participating in this study is that you may be contributing 
to the improved treatment of your identical twin. The potential benefit to others would 
be the development of further knowledge about the use and side effects of this 
approach for treating HIV-infected patients, and possibly the development of a new 
strategy for treating HIV infection. 
There is no cost to you for the procedures associated with this study, but if you 
require medical care at other institutions or from other physicians during the course of 
this study, you or your insurance will be charged for this care. If physical injury results 
from your participation in this study, immediate necessary medical care will be 
provided, but there is no provision for free medical care or for monetary compensation 
for such injury. Letters and results of tests performed at the NIH will be sent to your 
personal physician, and you are encouraged to remain in close contact with your 
doctor. You must receive routine medical care from your own physician, and you may 
not rely on the NIH for general medical care. 
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