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: 
CONTINUATION: page 3 nf 6 page: 
Once the immature blood cells are separated and the antibody removed from them, they are 
mixed together in the laboratory with three substances called growth factors which help the 
blood cells divide. Also mixed with the blood cells is the retroviral vector that carries the neo^ - 
gene into the blood cells. The vector is an organism that carries material from one cell to 
another. Retroviral vectors are prepared from a disabled type of mouse virus that does not have 
the ability to reproduce. The vector enters the blood cells and puts the neo^ gene into the cells’ 
genetic material (chromosomes). Once in the chromosomes, the neo^ gene will survive as long 
D 
as the cells survives. The neo^ gene serves no function in the blood cells, but rather “marks” 
them so we can identify them. The blood cells, vector and three growth factors are put together 
in a mixture called a culture for 3 days. After this, the cells are removed from the culture and 
“washed” to remove any extra virus or growth factor attached to them. The “marked” cells are 
then frozen and are returned to you at the time of transplantation along with the bone marrow 
and blood cells that have not been exposed to the vector. Two slightly different viruses will be 
D 
used to transfer the neof^ gene to your bone marrow and circulating blood cells. You will 
receive enough of your normal, unchanged bone marrow and circulating blood cells to produce 
blood count recovery in the expected time period after high dose chemotherapy. 
The standard blood drawings and tests that are required following bone marrow 
transplantation will be performed. These have been explained to you in the separate consent 
document. During your hospitalization and after you are discharged, blood samples will also be 
drawn to study your blood counts and to determine whether the neo— gene is present in the blood 
cells. Approximately two extra teaspoons of blood will be drawn once a week for these research 
studies. Bone marrow aspirations will be obtained weekly after your bone marrow is given back 
to you to test for the presence of the neo^ - gene. You will be given local anesthesia for these 
bone marrow aspirations. The side effects of the biopsies include pain, bleeding and infection. 
These bone marrow aspirations are scheduled as part of the original transplantation protocol to 
keep track of your bone marrow recovery. No extra bone marrow aspirations will be done 
because of the gene marking protocol, but an extra 1 teaspoon of marrow will be taken during the 
exam to test for the neo^ - gene. You will return monthly to NIH for evaluation after you are 
discharged from the hospital. Four teaspoons of blood will be drawn from you each month and a 
bone marrow aspirations will be obtained every three months to determine whether your bone 
marrow cells contain the neo^ gene. We request that you return periodically to the NIH for the 
rest of your life so that we may follow you for any side effects that may occur. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-25 1 4-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 09-25-0099 
[84] 
Recombinant DNA Research, Volume 16 
