Days 5,6,7 : PBSC harvested 
Days 5-10 : PBSC transduction ex vivo with FACC 
vector 
Days 8,9,10 : Transduced cells reinfused 
Day 1 1 : Patient discharge 
5.21 Objective signs and symptoms : Vital signs (blood 
pressure, pulse, temperature and respirations) 
weight and height will be done Study Days 1-11, 
5.22 Physical Examination : Target physical exam will be 
done on Study Day 0 and before discharge, 
5.23 Karnofsky Performance Status (see Appendix IV) 
will be done before discharge. 
5.24 Urinalysis : Routine urinalysis will be done Study 
Days 8-10 and upon patient discharge. 
5.25 Serum Chemistries : include uric acid, calcium, 
phosphorus, magnesium, amylase, triglycerides, 
transaminases (SCOT, SGPT) , alkaline phosphatase, 
LDH, total bilirubin, BUN, creatinine, albumin, 
total protein, electrolytes, and glucose will be 
done qod during Study Days 1-11 and at the time of 
discharge . 
5.26 Hematology : Complete blood count (CBC) , 
differential, platelets, and coagulation tests 
should include PT (Prothrombin Time) , PTT (Partial 
Thromboplastin Time) , and fibrinogen will be done 
daily during Study Days 1-11 and at the time of 
discharge . 
5.27 Pregnancy Test : Serum pregnancy test will be 
repeated monthly during the first year. 
5.28 Freezing Specimens : Additional serum, plasma, and 
cells should be separated and frozen at time of 
discharge . 
5.29 DNA/RNA Analysis : Circulating mononuclear cells 
will be analyzed using PCR- related techniques for 
the presence of vector gene sequences at time of 
discharge . 
5 . 3 Post -Treatment Evaluations 
For patients completing each PBSC cycle, the following 
evaluations will be done one month after the patient is 
discharged and repeated monthly until the next cycle 
begins. See section 5.4 if patient has completed the 
protocol or has completed at least one cycle (and has 
subsequently discontinued) : 
5.31 Objective signs and symptoms : Vital signs (blood 
pressure, pulse, temperature, respirations) weight 
and height. 
5.32 Physical examination : Targeted physical exam. 
5.33 Karnofsky performance status (see Appendix IV) . 
5.34 Urinalysis : Routine screening urinalysis and 
creatinine clearance. 
5.35 Serum chemistries : Include uric acid, calcium, 
phosphorus, magnesium, transaminases (SCOT, SGPT) , 
alkaline phosphatase, LDH, total bilirubin, BUN, 
creatinine, albumin, total protein, electrolytes, 
and glucose. 
5.36 Hematology : Complete blood count (CBC), 
Recombinant DNA Research, Volume 19 
[563] 
