BUN, creatinine, bilirubin, SGOT,SGPT, alkaline phosphatase, Na, K, Cl, 
CO 2 , albumin, total protein, glucose. 
8.2.2 The following investigations for monitoring of retrovirologic safety will 
be obtained pre infusion, then monthly for 3 months, 3 monthly for 1 
year and then yearly. 
Peripheral Blood in preservative free heparin (20 ml for BMT lab). This 
blood will be used for the following studies. 
Analysis for viral nucleic acids in PBLs by PCR. 
Reverse transcriptase assay 
Serology for retrovirus envelop protein 
8.3. Other tissues 
8.3.1 Autopsy will be requested if the patient dies 
9.0 EVALUATION DURING STUDY 
9.1 Follow-up Interval 
Patients shall be seen at thrice weekly intervals at St. Jude Children’s Research 
Hospital for 6 weeks, then weekly for 6 weeks then monthly for one year. 
Additional visits will be obtained as clinically indicated. 
9.2 Potential Accrual and Study Duration 
Fifteen to twenty patients will be eligible for this protocol per year so accrual for 
this first planned study should be complete in 18-24 months. We would then plan 
to substitute a follow up study using new cytokines or conditions for ex vivo 
expansion based on our preclinical studies 
10.0 STATISTICAL CONSIDERATIONS 
This study is projxjsed to investigate relationships between ex vivo exposure of CD34-I- 
BM cells to growth factors and the times to engraphment following reinfusion of these 
cells and to loss of evidence of presence of cells derived from the cells incubated with 
the growth factors. The assumption is made that neither disease nor conditioning 
regimen will affect the results. There are concerns for the safety of the patients and 
these concerns are reflected in the design through monitoring of deaths and excessive 
toxicity with stopping rules described below. 
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Recombinant DNA Research, Volume 19 
