Core D, operating through the Stanford Cellular Therapeutics & Transplantation (SCTT) Laboratory will provide cGMP-compliant cell processing and quality management for clinical trials under Specific Responsibility 1 for Projects 1-5. These include: 1) high purity sorting of naturally occurring regulatory T cells phenotypically defined as CD4+/CD25+/CD1271ow/FoxP3+ from allogeneic donor mobilized peripheral blood cells; 2) preparation of Mantle Cell Lymphoma cellular vaccines derived from autologous tumor cells; 3) high purity selection of CD8+CD45RA- memory T cells from allogeneic donor peripheral blood apheresis collections; 4) culturing Cytokine Induced Killer (CIK) cells from allogeneic donor peripheral blood cells; 5) isolation of Common Lymphoid Progenitor (CLP) CD34+CD127+Lin- cells free of mature T cells from haploidentical donor peripheral blood apheresis collections; 6) Management of product storage, product release testing for distribution, process documentation, and regulatory compliance oversight in support of the trials managed under the INDs project. Core D will also provide validation of cell processing procedures and materials for these projects as well as preparation of primary human tissue samples for immediate analysis and tissue banking of peripheral blood samples from allogeneic donor-recipient pairs. The SCTT Laboratory is located within Stanford Hospital and includes more than 2,000 square feet of class 100,000 (ISO 8) clean room space with four cell processing rooms each equipped with standard devices for cell processing; a cryopreservation room with controlled rate LN2 freezers and storage units; and areas for product QC testing and quarantine. Instrumentation for advanced cell manipulations includes three C02 incubators for cell culturing, two CliniMACS devices (Miltenyi Biotec, Bergish-Gladbach, Germany) for immunomagnetic cell selection, and an Influx Cell Sorter (Becton Dickinson Biosciences, San Jose, CA) adapted to clinical grade cell sorting. A second sorter located in the facility is configured for cell sorting and analysis to support the development and research goals of Projects 1-6 and Core C.
Core D will use cGMP-compliant cell processing to allow clinical safety and efficacy assessments of cellular products regulated under 21 CFR 1271, assists with the IND preparation and management for projects, and assists with sample preparation for correlative studies. Core D also provides sample processing for cell subset characterizations and tissue banking to assess immune regeneration post-transplant.
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