In Japan, Kyoto University Hospital has been conducting an investigator-initiated clinical study since 2018 to confirm the safety and efficacy of the therapy by a research group led by Professor Jun Takahashi of CiRA. The researchers and physicians involved in the clinical study have exchanged information with UC San Diego's personnel involved in this clinical study.
In this clinical study, as with the clinical study at Kyoto University Hospital, Sumitomo Pharma will produce and provide iPS cell-derived dopaminergic progenitor cells. These cells will be produced in Japan from QHJI donor-derived iPS cells provided by the iPS Cell Stock Project of CiRA_F. Sumitomo Pharma will also provide financial support for the conduct of this clinical study. The data from this clinical study will be used for further development of the therapy in the United States.
In order to make technologies and know-how in the regenerative medicine/cell therapy area available to patients worldwide as soon as possible, Sumitomo Pharma, CiRA and CiRA_F are collaborating to commercialize this novel therapy. In addition to this clinical study, Sumitomo Pharma is preparing to initiate a company-sponsored clinical study outside Japan.