This site contains information, procedures, forms and contact information for marrow and Peripheral Blood Stem Cell purging and/or cryopreservation procedures carried out by this laboratory.

The animated graphic shows magnetic beads being used to remove tumor cells from stem cells with a magnet.  - Magnetic bead  - Tumor cell    - CD34+ Stem Cell    - Bone Marrow Cells

Expanded Access Purging Protocol

Neuroblastoma is a malignant childhood tumor that often spreads to bone marrow. Neuroblastoma cells can be found in bone marrow or peripheral blood stem cells collected for re-infusion into patients (autologous transplantation) after myeloablative therapy. Purging of stem cells collected to support autologous transplant for high-risk neuroblastoma can be carried out by using monoclonal antibodies to attach small magnetic beads to neuroblastoma cells, allowing them to be separated from the stem cells using high-energy magnets.

The CHLA laboratory has carried out such tumor cells purging for > 10 years under an FDA Investigational Device Exception (IDE), supporting a number of different clinical trials, including the CCG 3891 trial that established myeloablative therapy followed by 13-cis-retinoic acid as standard of care for high-risk neuroblastoma (New Eng J Med 341:1165-1173, 1999). The most recent clinical trial using neuroblastoma purging from stem cells was the Children’s Oncology Group (COG) A3973 study which compared purged to non-purged peripheral blood stem cell transplantation in a randomized phase III clinical trial.

The Children's Oncology Group A3973 protocol has completed accrual and is closed. It will be years before the analysis of this protocol is completed. As the purging procedure has been used safely in over 1000 children with neuroblastoma and has been documented to remove neuroblastoma cells from bone marrow and PBSC, we have developed an "expanded access" protocol to allow patients to have PBSC or bone marrow purged with the purging device, which remains an investigational device.

The expanded access purging protocol has been approved by the FDA under BB IDE 2259. The expanded access protocol is approved by the CHLA Human Subjects Protection Committee (IRB). That protocol and the CHLA-IRB-approved consent and assent are provided as links below. The protocol must be approved by the IRB of any institution wishing to submit stem cells to CHLA for purging. While we recognize that individual IRB's will want variations on the consent, please stay as close to the example provided as possible. Critical is to include the portion about California Choice of Law as it is required by the CHLA administration.

Opening the Study at your Institution - How To's

Checklist for how to open the EXPANDED ACCESS PURGING PROTOCOL at your institution

1572 form template

Current Documents

2005-00051protocol amd#1 v 12-8-06.pdf

2005-00051protocol amd#1 v 12-8-06 TRK CHGES.pdf

2005-00051 Amd#1 memo v 12-8-06.pdf

2005-00051 Sample informed consent v 12-8-06

2005-00051 Sample assent v 12-8-06

Shipping Forms

Request_ship_stem_cells_form.doc

Bone_marrow_ship_form_5-25-06.doc

Stem_cell_harvest_shipping_form_comp_purge.doc

Bone_marrow_transmittal_form_for_immunocytology.pdf

Dataforms

Data_forms_packet_comp_purge_4-17-07.doc

Forms For Infusion At Site Other Than Coll Site.doc

Archived Documents

Purging_Protocol_v4-08-06.pdf

The MOU between CHLA and institutions previously submitting cells to CHLA for purging will remain in effect and no further action is required.

In addition to obtaining local IRB approval for the Expanded Access purging protocol, the local PI for that protocol needs to submit an FDA 1572 form and CV, together with a copy of the letter of approval from their local IRB to:

Robert Torres, AHSCT Program Co-Ordinator
Childrens Hospital Los Angeles
4650 W. Sunset Boulevard, Mailstop #54
Los Angeles, CA 90027
Tel : (323) 361-4565
Pager : (213) 209-1952 (numerical pager)
Fax : (323) 361-9324

[Site last updated : July 31st, 2008]