Development of Cell Transplantation System Using A Closed Culture for Heart Diseases

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In regenerative medicine using cell processing, a cell culture system is one of the highest obstacles. Most clinical trials in cultivated cell therapy needed huge cell processing center, which ensure the quality of manufacturing products. Our study examined the closed cell culture bottle, and resulted in good feasibility and safety in the first year. The differentiation capability and proliferation ability in this culture system were the same as those cultivated in open culture systems.Initially, we planned the clinical trial for peripheral arterial disease using the close cell culture system in the second year. However, the regulation for the cell processing would be stricter in the start of the second year, and we could not perform the clinical trial. We have focused in the safety of long-term cultivated cells in vivo environment, which is one to be examined in vitro environment in this study. Especially, carcinogenesis following the long-term culture is recognized in vitro. For cell therapy, the risk of carcinogenesis is carefully considered. In beagle dogs, autologous bone marrow-derived mesenchymal cell transplantation to the heart was performed. The cells had been cultivated for 5 to 10 passages before grafting. After 1 to 6 months, the histopathological analyses of the hearts were carried out. Neither carcinoma nor dysplasia was recognized. Neither heteroplasia nor inflammation was recognized.Mid-term cell culture could not induce carcinogenic changes. Our results suggest that cells passaged under 10 times would be not significant carcinogenic. At present, a company produced a robotic culture system for completely closed cell culture system in a trial version. Robotics strategy would reduce the cost and labor in this process.