CFD RESEARCH CORPORATION — Department of Defense SBIR Phase II: OSD11-H14

Description

Current methods for stem cell isolation are time-consuming, costly, and labor-intensive, and ill-suited for point of care applications. To overcome these limitations, we propose to develop and demonstrate a high-throughput, non-invasive, microfluidic stem cell analyzer to enable a rapid isolation of high-quality stem cell products from clinically relevant samples. Our technology enables significant improvements in processing time, automation, cell integrity, and logistical burden and cost, and opens a new possibility for interaoperative therapeutics. In the initial effort, key technology components were successfully developed. Device design, microfabrication, and experimental test were all undertaken to demonstrate microfluidic cell sorting and impedance characterization of stem cell differentiation, which markedly enhances TRL of the technology. This proposed effort will focus along two directions. First, a novel cell sorter will be developed to address challenges associated with clinical samples, such as large volume, high cell contents, target cell rarity, etc. Design optimization, fabrication refinement, and experimental characterization will be carried out to establish feasibility of the non-culture based stem cell isolation. Second, the sorter will be integrated with COTS component technologies for automated operation to improve GMP-readiness of the technology. The functionality of stem cell isolation will be extensively demonstrated using various pre-clinical samples, e.g., bone marrow, adipose, skin etc. A multi-disciplinary team with experience in all aspects of the proposed effort including microfluidics, stem cell bioengineering, regenerative medicine, and systems engineering has been assembled to ensure successful completion of project milestones.