Regenerative Medicine Advanced Therapy (RMAT) designation list

Japan stem cell clinical studies rapidly piling up

Shibata-et-al.-Cell-reports-2018-corneal-structures-made-from-hIPSCs

Japan is a leader in stem cell and regenerative medicine research, and in particular in clinical translation toward the bedside. Induced pluripotent stem cell (IPSC)-based investigational therapies are rightly an area of focus in Japan given their invention by Nobel Laureate Shinya Yamanaka. Small clinical studies based on IPSC have been initiated there for several …

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Japan’s dangerous gamble approving unproven stem cells for spinal cord injury

spinal-cord-injury-MRI

There is real hope for treating spinal cord injury with stem cell-based therapies in the future. However, unfortunately regulators in Japan have taken a major misstep in approving a not-ready-for-primetime mesenchymal stem cell (MSC)-based approach to spinal cord injury. Their decision is dangerous and unwise. In a Nature piece (linked to above) by David Cyranoski …

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