Kristin Goltry

Adult Stem Cell Therapies for Tissue Regeneration: Ex Vivo Expansion in an Automated System

Cell therapy is an emerging field whose technology is being investigated for the treatment of a variety of injuries and diseases affecting multiple tissue types. Many questions exist in the field of cell therapy, from understanding the basic mechanisms of action, to the optimal methods for preparing and administering cells to the patient. Answers to these questions will help determine the best cell source, optimal protocols for ex vivo manipulation of cells, and the best methods for delivery of cells. This chapter details one experience in the development of an ex vivo cultured autologous cell therapy for tissue repair, in this case the healing of non-union bone fractures. Methods were developed to expand a population of bone marrow mononuclear cells in culture resulting in a mixed population of cells with greatly enhanced bone-forming potential. These Tissue Repair Cells (TRCs) have been shown to possess multi-lineage potential both in vitro and in vivo in animal models. A manufacturing platform has been designed to culture and harvest the cell product in an automated closed fashion. After mixing TRCs with a bone scaffold material, cells maintained their ability to proliferate, secrete cytokines, and differentiate into the desired cell lineage. Preliminary results have demonstrated that TRCs can be successfully implanted and heal bone fractures in the clinic.