Rohto, Osaka Univ. Tie Up for Stem Cell Research, Aim for Approval of Regenerative Medicine Products
(Aug.5.2016)
Rohto Pharmaceutical and Osaka University Graduate School of Medicine announced on August 2 the establishment of a joint research course to accelerate the commercialization of regenerative medicine products using mesenchymal stem cells.
Column 1 0 1 Rohto CEO Kunio Yamada (second right)
Through the joint research course on advanced stem cell therapeutics, they will conduct research on serious heart failure using stem cells manufactured by Rohto with the aim of obtaining approval of a regenerative medicine product at an early date. Researchers will evaluate pharmacological study models and conduct preclinical research using mesenchymal stem cells provided by Rohto. If all goes well, the two parties will arrange an investigator-initiated trial with the goal of obtaining conditional approval.
The course was introduced in July this year and will continue through March 2021. Work will begin with five researchers including Professor Shigeru Miyagawa and three researchers from Rohto.
In a press conference the same day, Rohto’s chairman and CEO Kunio Yamada said that the course will enable “one-stop development” from exploratory research through clinical trials. He also revealed plans to tie up with another company with expertise in materials and other areas. “We want to collaborate with other (pharmaceutical) companies for the approval and launch of products,” Mr Yamada said.
Rohto expects its product for serious heart failure to enter a non-clinical study this fiscal year and a clinical study in FY2018. Rohto believes its mesenchymal stem cells could have various clinical applications, so it will consider the possibility of future tie-ups with Osaka University based on the foundation built through the joint research course.
Rohto has established technology to culture adipose-derived allogeneic mesenchymal stem cells in serum-free media that contain no ingredients derived from animals. The company has installed automated cell culture equipment at its research facility in Kyoto..........."..Catch us if you can " ....Vin
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