Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
Immunocytological assays (performed at Cedars Sinai Medical Center, Los Angeles, 
California) will be used to monitor the transplanted patient for disease relapse as well as 
to quantitate neuroblastoma cells in the marrow before and after ex vivo immunomagnetic 
purging. 
Reverse transcriptase, S + L' and focus forming assays will be performed on transduced 
purged marrow for detection of retrovirus. To date, no marked marrows have been 
positive in any of these assays (Malcolm Brenner, personal communication). 
Bone marrow aspirates will be performed as clinically indicated for diagnosis and 
documentation of marrow recovery, and at day 28 and 60 following transplantation for 
analysis for the presence of the neogene. 
Samples will also be set up in neuroblastoma colony forming assays to detect the 
presence of clonogenic tumor cells (performed at both St Jude Children’s Research 
Hospital and Cedars-Sinai Medical Center). Colonies will be phenotyped to confirm that 
they bear neuroblastoma-associated antigens. Colonies derived from marked tumor cells 
will be detected by PCR. 
Procedures for freezing, transport, and thawing of bone marrows will be monitored by 
testing sterility, viability and CFU recovery on post-freeze aliquots at St. Jude Children’s 
Research Hospital and by testing the same parameters at the participating institution on 
the thawed bone marrow immediately before infusion. 
Peripheral blood samples may be taken following transplantation at the discretion of the 
investigator to analyze for marker gene insertion to provide information about the 
hematologic reconstitution following autologous bone marrow transplantation. 
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