Stem cell research is an emerging field with the promise of creating dramatic new approaches for disease treatment and drug discovery. The research and regenerative medicine market space for stem cells is one of the most dynamic areas in the life science industry today. Globally, the stem cell market is growing at a CAGR of 24.2% and will reach an approximate value of US$119.52 billion by 2019, and technological advancement is believed to be one of the key factors that will drive growth in this field. Cell Microsystems is North Carolina-based start-??up biotechnology company whose mission is to commercialize a novel, yet affordable, platform for the efficient isolation of viable, single cellsor colonies from a mixed population without the need for release from the culture substrate, an often times detrimental procedure to the cell. The company's CellRaft (formerly IsoRaft) technology is based on a unique cell array developed by the Allbritton Laboratory at the University of North Carolina (UNC) at Chapel Hill. The core technology comprises a disposable microarray (the CellRaft Array) for culturing cells and a simple, manually operated instrument for isolating the cell/colony of interest. While a number of commercially available technologies claim capabilities toward identifying and selecting specific cells, such as stem cells, limitations remain, including cost, a need for large sample sizes, collection via cell-damaging detachment from the culture surface, and restrictive criteria for identifying cells of interest. In contrast,the CellRaft technology represents a rapid, user-friendly, and affordable cell isolation system. Phase I efforts focused on tailoring theCellRaft(tm) System for stem cell research. A range of materials were evaluated for incorporation into the CellRaft resulting in a consumable with optimized flexibility, culture compatibility, surface roughness and geometry (concavity). Methods were also standardized for the tracking and collection of single CellRafts. Finally, intestinal epithelial stem cells (IESCs) were seeded on CellRafts, with novel correlations observed between gene expression and morphology of single cell-??derived IESC enteroids. These data, recently published in Nature Cell Biology, provide strong proof of concept that stem-?cell?niche biology can be replicated and studied with the CellRaft System. To expand these studies and initiate commercialization of this powerful system, Phase II will focus on development of an Automated Isolation and Recovery (AIR) System comprising an instrument with appropriate optics and sample handling capabilities, automated signal analysis software, and commercial scale manufacturing of the CellRaft consumable, the CellRaft Array Prototype systems will then be validated internally by Cell Microsystems, as well as by external collaborators with various interests in stem-cell biology applications.
Understanding stem cell biology requires the isolation and molecular analysis of individual cells, with ensemble responses of many cells often masking variations in critical differentiation pathways. Cell Microsystems and its founder Dr. Nancy Allbritton, have pioneered an innovative single cell isolation technology, commercially marketed as the CellRaft System. During this Phase II proposal, we will expand on this technology developing prototypes of the CellRaft AIR System, providing an unparalleled degree of workflow automation for single cell isolation. Prior to being made broadly available through Cell Microsystems' Early Adopter Program, the prototype system will be: 1) prepared for commercial scale manufacturing, 2) tested for preliminary premarket safety and 2) externally validated in two University of North Carolina stem cell laboratories.
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