Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
TABLE 6.1.8.2 
Required Observations 
• 
Z -5 
*3 2 
w to 
M 
X 
x 
e 
« r 
Es 2 
X 
X 
X 
X 
IC. don 
studies 
M 
X 
X 
X 
to 
jd *a 
a i 
2 < 
M 
X 
X 
. o 
•1 
Q ac 
M 
X 
M 
2* 
a « 
X 
X 
X 
«* 
• 
J5 
M 
X 
X 
micro 
screen 
* 
X 
X 
< 
•• 
5 
X 
X 
X 
X 
X 
Chan 
II 
X 
8 
M 
eZ 
X 
X 
X 
to 
>* 
JB 
An 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
© 
to 
& 
© 
> 
to 
X 
Jd 
* 
>s 
x 
x 
■vs 
>s 
to 
<•> 
i 
►v 
X 
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►v 
to 
T3 
to 
T» 
o. 
to 
a 
X 
to 
>s 
4 
N 
>s 
•3 
X 
>v 
■3 
>s 
•3 
•3 
<e 
*s 
•3 
•3 
•• 
»■* 
-3 
IN 
Jd 
i 
n 
jd 
© 
1 i 
«• 
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X 
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Jd 
© 
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© 
© 
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[472] 
Recombinant DNA Research, Volume 16 
Phyia physical evaluation; PS-pcrformancc italui; CBC includes differential and platelets; Chan, 1 l*blood chemistries; 
Coagacoagulatloa screen; UA-ruine analysis; Micro »creen«HIV, HSV, CMV, BBV, Hepatitis, and Toro screen; 
Markr anal- in situ hybridization and/or PCR/RFLP; 1C A clon-lmmunocytology aod clono|cnlc tumor cell assays; 
IP*lmmunofluoreiccnce;Safeiy studies-sieriliiy ft viability 
