SBIR Phase II: Selection and Storage of Hematopoietic Stem Cells in a Novel Bioreactor

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This Small Business Innovation Research Phase II project will utilize Cytomatrix's three-dimensional biomatrix, Cellfoam, as the foundation of a stem cell cryopreservation system that pre-selects and cryopreserves hematopoietic progenitor cells (HPCs) in a single, integrated device. Phase I research demonstrated that Cellfoam mediates the enrichment of HPCs from unfractionated, ficoll purified mononuclear, and CD34+ selected cells during pre-culture and maintains their viability and functional capacity during cryopreservation. Building on these feasibility findings, Phase II will develop a Cellfoam cryopreservation prototype by addressing the following aims: 1) Optimization of pre-culture reagents, including culture media; 2) Optimization of cryopreservation protocols, including cryopreservation solutions; 3) Evaluation of the in vivo engraftment capabilities of HPCs using an NOD/SCID mouse model. The work will demonstrate the ability of Cellfoam to foster HPC enrichment and cryopreservation for clinical applications, such as long-term stem cell storage and bone marrow transplantation, for which current approaches are not optimal. Commercialization of Cellfoam systems for the first-ever integrated selection, storage and modification system for HPCs is anticipated to meet the needs of growing markets in cord blood storage, bone marrow transplantation and gene therapy. The markets are forecast to exceed US$600 million annually in the next decade.