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Cytomatrix |
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Selection, Expansion and Storage of Cord Blood Stem Cells in a Novel Bioreactor |
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| National Science Foundation, Phase IIB SBIR Hematopoietic stem cell transplantation remains the favored treatment for a variety of hematological and immune deficiencies. In addition to the difficulty in identifying a histocompatible donor, the very nature of hematopoietic progenitor cells (HPCs) limits their use in the clinic. It has been estimated that 5 x 106 CD34+ cells/kg are required for successful reconstitution of the hematopoietic system following ablative treatments however, resident HPCs in bone marrow (BM), mobilized peripheral blood (mPB) or umbilical cord blood (UCB) exist in limited numbers. Regardless of the source, HPCs are routinely cryopreserved upon receipt until such time as the cells can be used for reconstitution. Current cryopreservation and cryorecovery procedures yield a reduction in cell viability and repopulating capacity thereby further reducing the number of HPCs for transplantation. The following requirements would be necessary for an ex vivo system to overcome the limitations of HPCs use: Expansion of HPCs; Cryopreservation and cryorecovery of the HPCs; Maintenance of the viability, multipotency and engraftment capacity of expanded HPCs. Expansion systems to date have proven inadequate for clinical use due to the need for high concentrations of cytokines and animal-derived serum or protein supplements. Cytokines are costly to produce and to qualify for clinical use. Further, while various cytokine combinations support the survival and expansion of cells in vitro, they also promote the differentiation of HPCs, which reduces their long-term engraftment potential. Through the company's NSF Phase I and II SBIR work, Cytomatrix has developed two integrated systems aimed at addressing the existing clinical needs of stem cells expansion and storage: 1) a novel culture system based on our proprietary, three-dimensional cell growth matrix (the "Cytomatrix™") that enables the long-term survival and multipotency of primitive HPCs in the absence of exogenous cytokines and serum and 2) a smart cooling box and mini-module dialysis system complete with software for cryopreservation and cryorecovery of HPCs. Accordingly, we have met and exceeded all of the Phase I and II objectives and achieved the following:
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