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January 23, 2017

Discontinuation of the second batch of iPS cell lines for regenerative medicine

The Center for iPS Cell Research and Application (CiRA), Kyoto University, commenced the iPS cell stock project for regenerative medicine. In August 2015, the stock project began distributing the first batch of iPS cell lines prepared from peripheral blood, and, in August 2016, we began distributing the second batch of iPS cell lines prepared from umbilical cord blood.

In November 2016, we realized that during the induction process of the second batch of iPS cell lines from the umbilical cord blood, the cells may have been exposed to an unintended plasmid encoding green fluorescent protein (GFP). Further investigation failed to rule out this possibility. Since the induction step is most critical during iPS cell generation, we decided not to use the second batch for clinical purposes. The iPS cell lines have not been used in patients. We will generate iPS cell lines again from the same umbilical cord blood samples as quickly as possible for clinical purposes. We have confirmed that the first batch of iPS cell lines made from the peripheral blood were not exposed to the GFP plasmid, and those will keep being distributed for clinical purposes.

CiRA is now in the process of improving its management system to prevent this kind of incidents from recurring. It will team with Takara Bio Inc, a biotechnology company with expertise in cell production, quality evaluation, and manufacturing standards. These changes are aimed to advance the iPS cell stock project for regenerative medicine.

CiRA Director Shinya Yamanaka said, "I would like to apologize to all who have supported this project and scientists who have been working on the cell lines for causing this problem. By working with Takara Bio, we will strengthen the management of the stock project to promote regenerative medicine using iPS cells."

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