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 
V 
cm JOYNIurveER CONTINUATION: paoe ^ , of ^ pages. 
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fraction of his/her lymphocytes removed from the blood by a procedure called lymphapheresis. 
I 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. 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 may be introduced into the cells depending upon a random assignment of 
treatments. The process involved in introducing the new gene is described in a separate consent 
form that you may also be asked to sign. 
I 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 
I numbers of cells Is approximately 3 weeks from the time your twin undergoes lymphapheresis. 
I Once the desired numbers of cells have been attained, you will come to the NIH Clinical Center to 
receive these cells by intravenous infusion. 
! At the start of the study, you will be assigned in a random fashion to receive either genetically 
unmodified lymphocytes or genetically modified lymphocytes at one of three dose levels. Your 
chances of being assigned to one of the modified lymphocyte treatment groups is 75%. The study 
is divided into two treatment periods. In Period I you will receive a single infusion of cells followed 
by 8 weeks of observation. In Period II you will receive up to 6 additional infusions of cells of the 
same type as in Period I every 8 weeks. The cell dose In Period II may be adjusted up or down 
depending upon the results of Period I; therefore, there may be a delay of several weeks between 
Treatment Periods to allow for other patients to complete their treatment and observation. 
For the first cell infusion, you will be admitted to the inpatient ward of the NIH Warren G. Magnuson 
Clinical Center. An Intravenous catheter (a small plastic tube) will be inserted into an arm vein. 
! However, if a suitable vein cannot be found, you may need to have a special intravenous catheter 
placed into a large vein in the neck or chest. This procedure would require a local anesthetic 
: (lidocaine or Novocain) and would be performed by a physician in the intensive care unit. Once an 
I intravenous catheter Is established, the gene-modified cells obtained from your twin will be infused 
I over a 60 minute period. During the infusion and for the next 24 hours, your vital signs 
j (temperature, pulse, blood pressure, respirations), blood oxygen concentration, and urine output 
I will be monitored regularly, as outlined in the protocol. Blood samples will be obtained from you at 
I 1 , 2, 4, and 6 hours after the start of the infusion to monitor for the presence of the gene modified 
I cells. If there are no complications, you may be discharged from the hospital the following day, but you may 
I need to return to the NIH as often as daily for the next 3 days for blood tests and then weekly as instructed. 
For the next series of infusions, the identical schedule of tests and frequency of visits will be 
followed. However, if the first infusion was uncomplicated, subsequent infusions may be 
administered on an outpatient basis and monitoring of vital signs, etc., may last for 6 hours (rather 
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