ID. 21 3 224 668V 
a/ * w 
0CT-2B-94 09.07 FROM ■ USC DIV. HEMOTOLOGY 
3. This protocol is not identical to another RAO-approved protocol. 
4. This protocol is similar to the RAC-approved protocol “Genetic marking with 
retroviral vectors to study the feasibility of stem cell gene transfer and the biology 
of hematopoietic reconstitution after autologous transplantation in multiple 
myeloma chronic myelogenous leukemia or metastatic breast cancer”. The major 
differences between the protocols are: 
a. We will study lymphoma patients in addition to breast cancer patients. The NIH 
protocol does not include lymphoma patients. 
b. We will transduce two peripheral blood progenitor cell harvests, as opposed 
to one PBPC harvest in the above mentioned protocol. We hope to Increase the 
rate of detection of marked cells after transplantation. 
c. In our transduction method, the cells will be incubated for 48 h with IL-3 and IL-6 
and they will be exposed to the vector only during the last six hours of the 
Incubation. This differs from the NIH study In which the cells are incubated 
for 72 hours with both the vector and the growth factors and the 
transduction medium' is changed every 24 hours. In addition, our 
Incubation medium does' hot include stem cell factor. We chose this 
method to reduce the incubation time and the amount of supernatant 
required. Our pre-dinical results Indicate that this method results in similar 
transduction efficiencies and expression. 
D. LOCAL COMMITTEE APPROVALS 
1 . A copy of the Institutional Bio-Safety Committee approval is provided. 
2. A copy of the Institutional Review Board approval is provided. 
E. INFORMED CONSENT DOCUMENT 
1. A copy of the IRB-approved Informed Consent is provided. 
The text undertying items a, b, c, d, e, f are underlined in the Informed Consent 
We have added sentences to the informed consent that address items a and e. 
F. ADDITIONAL INFORMATION 
1 . Bio-sketch of the principal investigator and the key collaborators are enclosed. 
10 - 27*94 
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