Development of the device for ex vivo expansion of cord blood stem cells and its clinical application

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Recently, cord blood has been calling attention as a third source for supplying hematopoietic stem cells, next to bone marrow and peripheral blood. However, the biggest problem with cord blood is its limitation : the amount of hematopoietic stem cells contained, which restricts the administration of cord blood to adults. We developed a unique system for culture in which cord blood and stromal cells are separated by membrane, but still keep contact through pores with 0.45 micrometer. We were able to expand cord blood stem cells with this system in experiments. For the clinical application, we have to attain 1) control of the contamination of xenogeneic proteins and micro-organisms derived from murine stromal cell line, 2) sacale up the culture system, and 3) evaluation of the engraftment and long-term sustain of hematopoiesis. For these purposes we ordered the bioventure company, Bioreliance Co., to check the contamination of xenogeneic proteins and micro-organism in the reference of the guideline from FDA and confirmed the murine stromal cell line, HESS-5, was free from xenogeneic micro-organism. We also developed the large scale culture system by using membrane of 100 cm2. We evaluated the expansion of SRC by using of quantitative SRC assay, and confirmed more than 10 times expansion of SRC within 5 days of culture. We started clinical protocol after the disussion in IRB.