US company Cytori has been informed that seven new investigator-initiated clinical studies covering a range of indications in Japan using adipose-derived regenerative cells have been approved by local ethical committees.
Cytori, which will not sponsor these studies, will continue to work with country authorities, such as the Ministry of Health, Labor and Welfare in Japan, to obtain specific regulatory approvals for its products. Data from these studies may benefit the firm by establishing and broadening the use of its Celution System platform, which is currently sold in more than 30 countries around the world.
Investigator-initiated studies are sponsored entirely by each hospital, which independently oversees data monitoring and reporting.
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