Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
The neuroblastoma bone marrow purging system is comprised of the following 
components: 
(a) Solutions of monoclonal antibodies directed against cell surface antigens found 
on neuroblastoma cells. The hybridoma lines were developed under the direction 
of Dr. John Kemshead at the Imperial Cancer Research Foundation (ICRF) 
laboratories in London England. This group of antibodies was chosen so as to 
cover the majority of variants of antigens found on clinical neuroblastoma 
isolates. 
(b) A device for separating paramagnetic microspheres from marrow suspensions 
(the MaxSep™ Magnetic Cell Separator) and the magnetic cell separator fluid path 
disposable set. The MaxSep™ device consists of two separate permanent magnets 
and a programmable roller pump. The larger primary magnet performs the 
primary separation of targeted tumor cells from marrow, while the smaller 
magnet is used to retain any residual microspheres that escape capture by the 
primary magnet. The associated disposables comprise a sterile biocompatible 
fluid path for the manipulation of the marrow. 
(c) Paramagnetic microspheres coated with sheep anti-murine antibody 
(Dynabeads M-450 sheep anti-mouse) The antibody coated microspheres bind 
all classes of murine immunoglobulin and provide the mechanism for targeting the 
antibody coated cells for removal. 
(Refer to Section 3.2 of the pre-IDE document for further details.) 
6. 1.5.2 Rationale for Using Gene Markers 
Because autologous bone marrow cells are phenotypically and genetically identical to the 
cells in the recipient, it is not possible to determine the source of disease relapse 
following ABMT, and to demonstrate the clinical efficacy of ex vivo purging procedures. 
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Recombinant DNA Research, Volume 16 
