Responses to Initial Review 
Appendix B 
RAC Application 
Kenneth L. Brigham, M.D 
PRINCIPAL INVESTIGATOR; Kenneth L. Brigham. M.D. 
TITLE OF PROPOSAL: Expression of an Exogenously Delivered Human Aloha- 1 Antitrypsin Gene in the Lungs 
ITEM 1 (Continued): 
After the lung is washed with sterile water, we will inject into that same area of the lung the DNA mixed 
with liposomes. The DNA which we are using makes a protein (alpha 1 -antitrypsin) that protects the lungs. Alpha 
I -antitrypsin is a normal protein found in the lungs of humans. 
The amount of material, DNA/liposome mixture, which we will inject is small. We only want to see whether 
this method works in human lungs. After we instill the DNA/liposome mixture, the bronchoscope will remain in 
place for approximately 15 minutes to make sure that as much of the DNA/liposome mixture is taken up by the 
lung. The bronchoscope will then be removed. If any excess fluid is seen when the bronchoscope is removed, this 
will be suctioned out of the lung through the bronchoscope. Then, after you have your surgery and the lung is 
removed, we will take part of the lung which has been removed to test whether the gene we put in works. 
We also want to draw a small amount of blood from a vein in your arm just before the bronchoscopy and 
again at the time of your surgery. The total amount of blood will be about 4 tablespoonfuls. We will also obtain 
an additional chest x-ray prior to your surgery to evaluate for the presence of pneumonia. 
The costs of the bronchoscopy and all laboratory work including chest x-ray will be paid by the Department 
of Pulmonary and Critical Care Medicine. 
ITEM #2: The parts of this study that are being done solely for this study are: 
What we propose to do is entirely for the purpose of this study. We will in no way interfere with or alter 
your medical care. 
Recombinant DNA Research, Volume 19 
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