Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
d) Autopsy summaries, where appropriate 
e) Informed consent documents 
Laboratory Assessment 
All hematologic, histologic, immunologic, clonogenic, and marker gene assessments of 
bone marrow aspirates and biopsies performed preharvest, at harvest, and within 24 
months following transplandon. 
6.1.7 STUDY PROCEDURES 
In-patient and out-patient procedures will be based on the participating institution’s 
treatment protocol on which the patient is entered. 
6.1.8 CLINICAL AND LABORATORY PARAMETERS 
6. 1 . 8 . 1 Clinical Assessment 
Clinical assessment will be based on the participating institution’s treatment protocol on 
which the patient is entered. For all protocols, these will include: 
Pre-harvest 
a) BM aspirate/biopsy 
b) physical/performance status 
c) CBC with platelets, differential 
d) diagnostic radiology 
e) blood chemistries 
f) urine analysis 
g) coagulation screen 
h) microbiological screen 
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Recombinant DNA Research, Volume 16 
