2. Bronchoscopies, 
bronchoscopy. 
Several types of risks and discomforts can occur from 
a) Cough. The meperidine that is given by vein will help reduce the coughing. 
b) Pneumothorax. When small pieces of tissue are removed from the lung, a 
fluoroscope (xray machine) will be used to try to guide the pinchers away from the 
edges of the lung where leaks can occur. 
c) Bleeding. Blood tests will be done before the procedure to be sure that your blood 
clots normally in the laboratory. 
d) Fever. Acetaminophen (Tylenol) will be given to prevent or lessen any fever. 
e) Pneumonia. Early antibiotic treatment will given at the first sign of pneumonia. 
f ) Allergic reactions to the medications. You will be asked if you are allergic to any 
of the medications before they are given. 
3. Complications caused by the virus. 
a) Over production of cystic fibrosis protein. The smallest amount of virus that 
will likely transfer the gene to your cells will be used. 
b ) Multiplication of the virus. A defective virus is being used that cannot multiply 
by itself. 
c) Damage to the airway cells. The virus is to be delivered at high concentration to 
only a small part of the lung. If this segment is temporarily or permanently 
damaged, it will represent less than 5% of your lung tissue. 
d) Spread of the virus. Tests will be done to see if virus can be found outside your 
body. If so, you might be asked to remain in the hospital longer than the planned 2 
weeks to see if the virus number is decreasing. 
e ) Cancer. You will be given long term follow-up evaluations. 
f ) Changes in the body's eggs and sperm. Because of your inability to have children, 
you would not be able to pass the changes to future generations. 
4. Exposure to xrays. The minimum amount of xrays will be used to obtain the safety 
information needed for the study. 
5. Withdrawing from the study. We will attempt to perform the studies in the most 
gentle way possible to minimize your discomfort. We hope to be able to convince you that 
once started, you will want to complete the study. 
6. Loss of privacy. All requests for information will be directed to the University of 
Michigan Public Relations Office to minimize the chances that your identity will be 
accidentally disclosed to the public. 
Expected benefits to subjects or to others 
Your health will not benefit from participating in the studies. The area of the lung that is 
being exposed to the virus is too small for you to notice any improvement, even if the 
genetic defect is corrected in that region of lung. However, the information gained from 
the tests will help determine if this approach to gene therapy is safe and if the normal 
cystic fibrosis gene will correct the defect in some of your airway lining cells. 
Appropriate alternative procedures 
No alternative form of gene therapy has been performed in cystic fibrosis patients. 
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Recombinant DNA Research, Volume 16 
