select only those with an estimated chance of 5 year survival of 50%, the patient must 
fulfill the following criterion [Huang, 1987; Shwachman, 1958]: 
d) Shwachman-Kulczycki clinical score ^ 50. 
Exclusion Criteria 
1 . Conditions which would place the patient at increased risk for complications from 
participating in the study would include: 
a) Pneumothorax within the last 12 months 
b) Insulin-dependent diabetes 
c) Asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoid 
therapy within the last two months 
d) Sputum culture growing a pathogen which does not have in vitro sensitivity to at 
least two types of antibiotics which could be administered to the patient. 
e) History of major hemoptysis: Coughing up greater than 250 ml of blood within a 
24 hour period during the last year. 
f ) Any medical condition or laboratory abnormality which, according to the opinion 
of the investigators, would place the patient at increased risk for complications. 
2. The patient will be carefully evaluated for evidence of active adenoviral infection. 
History and physical examination will be used to identify clinical evidence for adenoviral 
syndromes such as coryza, pharyngitis, tonsillitis, bronchitis, pneumonia, 
conjunctivitis or diarrhea. A variety of specimens will be evaluated for adenoviruses 
using culture techniques as well as immunofluorescent and enzyme-linked 
immunosorbent assays performed directly on the specimen. Evidence for active 
adenoviral infection at the time of therapy will be a basis for exclusion. Another 
relevant question relates to previous exposure of the gene therapy recipient to Ad5 and 
similar serotypes based on adenovirus specific neutralizing antibodies. We expect that 
virtually all of our adult patients will have been exposed to adenoviruses that confer 
humoral immunity to Ad5. This is based on a large body of literature which indicate that 
the lower numbered adenoviruses Adi , Ad2, Ad5, and Ad6 are endemic in most countries. 
The prevalence of adenovirus-specific neutralizing antibodies by the age 3 is estimated 
to 80% in the USA (Hueber et al., 1954; sterner, 1962; Hall et al., 1971; Foy and 
Grayston, 1976). All patients enrolled in the protocol will be evaluated for previous 
exposure to Ad5 and related types using a variety of serologic assays. We expect that 
essentially every candidate patient will be seropositive. In fact any patient that is not 
seropositive will be excluded from the protocol. Existing humoral immunity to the 
virus is considered a safety feature thereby preventing dissemination beyond the 
localized area of lung to which the recombinant is exposed. . 
3. Drug therapy: Treatment with systemic glucocorticoids within two months prior to 
initiation of the study. 
4. Inability to comply with the protocol. Patients will be excluded if, in the opinion of the 
investigators, the patient has characteristics which would make compliance with the 
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Recombinant DNA Research, Volume 16 
