Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
randomly selected 400 colonies, the proportion of cells originating from each marker will 
be determined by PCR. Each relapse containing marked cells will be processed 
s imilar ly, and the proportion of cells arising from the purged and unpurged aliquots will 
be determined. Using an exact Wilcoxon signed rank test, we will test for evidence that 
unpurged marrow contributes more relapse progenitor cells than the purged marrow. 
This study would have low power for detecting differences, but could contribute 
information for design of additional studies to address this question. 
6.2.2 SAFETY/TOLERANCE 
6.2.2. 1 Safety of the Ex Vivo Purging Procedure 
The safety of the ex vivo purging procedure will be assessed by performing the following 
tests immediately before and immediately after the purging procedure: 
sterility evaluation - aerobic and anaerobic liquid cultures & blood agar plates. 
Ex vivo purging should not result in introduction of microbial contaminants 
into the marrow. 
nucleated cell viability by trypan blue dye exclusion. Ex vivo manipulation of 
the marrow should not reduce nucleated cell viability by greater than 20%. 
6.2.22 Safety of the Treatment Plan 
Safety considerations associated with the gene marking procedure are discussed in 
Appendix D. 
The safety of the treatment plan will be assessed by evaluation of engraftment. The 
number of days to achieve sustained engraftment (ANC > 500/ftl) will be recorded. 
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