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, expands 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:

• Optimization of pre-culture reagents, including serum free media and media supplemented with standard animal serum or with autologous patient serum.
• Optimization of cryopreservation protocols, including analysis of physical devices and cryopreservation solutions.
• Evaluation of the in vivo engraftment capabilities of HPCs cultured in large scale Cellfoam systems using an NOD/SCID mouse model.