Services

This facility currently supports a large number of clinical trials that require extensive in vitro cell manipulation. At present, the cellular components produced by the CMCF fall into four categories:

• Hematopoietic progenitor cell (HPC) components. The CMCF processes HPC components requiring no manipulation, minimal manipulation and also more extensive processing including the purging of tumor cells from autologous HPC, the positive selection of CD34+ progenitor cells or depletion of subset of lymphocytes using the Isolex 300i or the Miltenyi Clinimac systems.
• Tumor cell vaccines. The generation of tumor vaccines involves the production of autologous tumor cells genetically modified to secrete immune-stimulating cytokines such as GM-CSF to enhance tumor immunogenicity.
• Dendritic cell vaccines. Dendritic cells are generated from cultured monocytes with cytokines. They are further genetically modified to encode tumor antigens, pulsed with tumor-associated peptides or tumor cell lysate, or combined with adoptive immunotherapy to enhance tumor rejection.
• Adoptive immunotherapy. Protocols in this area involve the isolation, expansion, and ex vivo modification of defined lymphoid populations for infusion to boost specific immunity.

Other services provided by the Core include:

• Pre-clinical IND Preparation
• Validation consultation

Specialized instruments available for cell culture and cell selection:

• Baxter, Isolex 300i Cell Selection device
• Baxter, Cytomate Cell Harvester
• Miltenyi, Clinimacs Cell Selection device

Policies

• Policy for Off-Protocol Use of Isolex 300i to Enrich CD34+ Cells [PDF FILE]
• New Cell Therapy Development and Review Policy [PDF FILE]

Circular of Information for Cellular Therapy Products

• 2007 Circular