Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
The washed beads are added to the washed marrow cells in a total volume of 
approximately 80 ml in a one liter Baxter Lifecell™ flask (Code 4R2110). The mixture 
is incubated with slow (4 rpm) end-over-end rotation (using a laboratory rotator - Cole 
Parmer Rototorque) at 4°C for 30 minutes. The volume is then increased to 200 ml with 
buffer. After mixing by gentle swirling, the flask is placed in a plasma expressor (Baxter 
Code 4R44140) and all air is withdrawn using a needle and syringe. The flask is then 
attached to the pre-primed tubing set on the MaxSep™ magnetic separator. The marrow 
is processed through the separator at a flow rate of 10 ml/minute using a primary magnet 
angle of 45°. The effluent cells are collected into a one liter Lifecell flask placed on 
i crushed ice. Detailed instructions for use of the MaxSep"* are given in Appendix C. 
6. 1 .5 .5 Storage and Administation 
Immunomagnetically-purged marrow will be cryopreserved with 10% dimethyl sulfoxide 
(DMS0) and stored in the liquid phase of liquid nitrogen. Marrows from referring 
institutions will be returned in a commercially available dry shipper. Marrows will be 
thawed and reinfused according to the clinical protocols in place at participating 
institutions (see Section 6.3.9). 
6.1.6 DATA COLLECTION 
The following data pertinent to this study will be reviewed. (Hospital charts and lab 
notebooks will also be available as needed.) 
Clinical Assessment 
a) Flow sheets documenting dates and doses of therapy is well as clinical 
chemistries, hematologic parameters, the clinical status and occurrence of any 
adverse events and subsequent interventions 
b) Surgical summaries 
c) Date of entry to other appended protocols 
Recombinant DNA Research, Volume 16 
[467] 
