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RIKEN Resuming World’s First Ever Clinical Study of iPSC-Derived Cells in Humans

RIKEN Resuming First Ever Clinical Study of iPSC-Derived Cells in Humans

RIKEN Resuming First Ever Clinical Study of iPSC-Derived Cells in Humans macula

In major news released today, RIKEN announced that it is resuming its retinal induced pluripotent stem cell (iPSC) study in partnership with Kyoto University.

2013 was the first time in which clinical research involving transplant of iPSCs into humans was initiated, led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB) in Kobe, Japan. Dr. Takahashi and her team were investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration.

Although the trial was initiated in 2013 and production of iPSCs from patients began at that time, it was not until August of 2014 that the first patient, a Japanese woman, was implanted with retinal tissue generated using iPSCs derived from her own skin cells.

A team of three eye specialists, led by Yasuo Kurimoto of the Kobe City Medical Center General Hospital, implanted a 1.3 by 3.0mm sheet of iPSC-derived retinal pigment epithelium cells into the patient’s retina.[1]

Unfortunately, the study was suspended in 2015 due to safety concerns. As the lab prepared to treat the second trial participant, Yamanaka’s team identified two small genetic changes in the patient’s iPSCs and the retinal pigment epithelium (RPE) cells derived from them. Therefore, it is major news that the RIKEN Institute will now be resuming the world’s first clinical study involving the use of iPSC-derived cells in humans.

According to the Japan Times, this attempt at the clinical study will involve allogeneic rather than autologous iPSC-derived cells for purposes of cost and time efficiency.

Specifically, the researchers will be developing “retinal tissues from iPS cells supplied by Kyoto University’s Center for iPS Cell Research and Application,” an institution headed by Nobel prize winner Shinya Yamanaka. To learn about this announcement, view this article from Asahi Shimbun, a Tokyo- based newspaper.

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Footnotes:
1. Cyranoski, David. ‘Japanese Woman Is First Recipient Of Next-Generation Stem Cells’. Nature (2014): n. pag. Web. 6 Mar. 2015.

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