The training will be customized to reflect the diversity and broad-based growth in blood and marrow-derived cell therapies as well the interests and goals of the individual scholars. Six modules are offered with most modules lasting one month in duration. Each scholar will have the opportunity to select modules for their training experience lasting up to six months, which can also include a short term research project of the scholar’s interest.
- Manufacturing of Clinical Cell Therapies: Understand cGMP facility design, product development, clinical production, cryopreservation protocols, clinical applications for hematopoietic stem cells (HSC).
- Preservation of Cells: Understand the scientific principles of preservation followed by hands on training in preservation of cells. Issues unique to the preservation of cellular therapies will also be discussed.
- Hematopoietic Stem Cells: Describe an HSC graft selection algorithm for related vs unrelated, marrow vs peripheral blood stem cells vs umbilical cord blood (UCB) and an algorithm for UCB selection, review the rationale for cell processing (major vs minor incompatibility, DMSO removal), discuss the organizational complexity of a national donor registry and process of graft acquisition.
- Immunotherapy: Observe the clinical manufacturing of cellular immunotherapies (NK cells, T regulatory cells, MSC’s), learn to operate the fundamental instrumentation in cell processing, discuss the importance of cell therapy product testing and patient immune monitoring.
- Transfusion Medicine: Describe an approach to patient blood management and optimal blood utilization in general and in hematological disease/HSC transplant, describe an approach to optimal mobilization and HSC collection, discuss coagulation studies in the context of patients with hematological disease, observe both standard of care and novel cell processing method.
- Blood and Marrow-Derived Stem Cells for non-Hematological Diseases: Explore the potential application of cell therapy in non-hematological disease, discuss the complexities of clinical trial design, understand the importance of pre-clinical studies in support of an IND submission, observe manufacturing of marrow-derived MSCs, marrow mononuclear cell preparation, and immunomagnetic selection of various cell types.
Scholars accepted for training will be expected to develop learning objectives prior to their training and to participate in a qualitative assessment upon completion of their program.