CLINICAL CENTER HOSPITAL IMPACT STATEMENT 
(Projected Utilization of Resources) 
Protocol Title: Gene Therapy of the Respiratory Manifestations of Cystic Fibrosis Us ing 
a Replication Deficient, Recombinant Adenovirus to Transfer the Normal Human Cystic 
^ Fibrosis Trans membrane Conductance Regulator cDNA to Airway Epithelium 
Institute: NHLBI Principal Investigator: Ronald G. Crystal. M.D. 
following 
Start Date for S tudv : approvals Duration of Study: indefinite 
Drug Trial: Yes (X) No ( ) Phase: I (X) II ( ) III ( ) 
IND or IDE Required: Yes(x) No( ) Radiation Safety Review Required: Yes ( ) No (X ) 
Total Number (#) of # patients in 
Patients in Study: in pts. first year: 10 pts. 
maximum # patients 
at any time: 
6 pts. per 6 months 
Number of Inpatient 
Admissions per Patient: 9 
Average Length of 
Stay per Admission: 7-120 
# admissions 
adm. in first year: 2 . adm. 
pt. pt. 
length of 
first 
days admission: 120 days 
adm. adm. 
# admission in 
each subsequent 
year: 1~2 adm. 
pt. 
length of each 
follow-up 
admission: Z days 
adm . 
Number of Surgical 
Procedures per Patient: 
n procedures/patient 
length of 
pre-op 
stay: _0 days 
length of 
post-op 
stay: 0 days 
Nursing Unit(s) : 7 West Clinical Floor: 
Special Care Units: (Check any that will be used during the study) 
2J ( ) 10D ( ) 12W-LAF ( ) 5W-Care Room ( ) Other: 
Level of Nursing Care: (Check the most intensive level expected) 
( ) Ambulatory Care: e.g., 0-3 hrs. per 24 hrs . 
( ) Minimal Care (mild symptoms; minimal assistance): e.g., 3-6 hrs. per 24 hrs. 
(x) Moderate Care (frequent treatment, observation or instruction): 
e.g., 6-12 hrs. per 24 hrs. 
( ) Complex Care (extreme symptoms, need full assistance): e.g., 12-24 hrs. per 24 hrs. 
# Visits 
Total Outpatient in first 
Visits per Patient: 0 visits year: 0 visits 
pt. pt. 
# Visits each 
subsequent 
year: 0 visits 
pt. 
Is a flowchart of scheme included in the protocol? Yes & ) No ( ) . Please include a 
scheme or flowchart for complex protocols. 
Additional Comments: 
Recombinant DNA Research, Volume 16 
[ 771 ] 
JB:E0:CC: 11/12/86 
^ivuiu mji-iiy me cuieuieu uiriitai center 
Coordinator at 496-9076. The P.I. will be 
department, institute, or tne protocol «evieu 
contacted if clarification is needed. 
