SBIR-STTR Award

This Small Business Innovation Research Phase I project will examine the ability of a novel three-dimensional biomaterial, Cellfoam, to pre-select, expand, cyopreserve and transduce hematopoietic progenitor cells (HPCS) present in cord blood (CB). Preliminary data from NSF Phase I award DMI-9661006 show that CD34' HPCs cultured in Cellfoam without exogenous cytokines are expanded 8-10 fold while maintaining their viability and multipotency. IIPCs can be cryopreserved in Celifoam, thawed, re-cultured, and transduced efficiently with a retroviral vector. We propose to examine a novel application of Cellfoam: the integrated pre-selection, expansion, cryopreservation and transduction CB HPCS. We will utilize cells from either unfractionated, Ficoll purified or CD34' selected preparations of pooled CB samples to evaluate the survival, phenotype and multipotency of cells pre-cultured in Cellfoam without cytokines for up to four weeks and cryopreserved in the same units for one month. We will also examine the retroviral transduction of thawed HPCs over three weeks. By using different CB fractions we may isolate novel, critical subsets of HPCS. This work will facilitate commercialization of Cellfoam systems for the first-ever integrated selection, storage and modification system for CB HPCs in an HPC banking market anticipated to exceed US $600 million annually in the next decade.

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.