Embryo-Like Stem Cells Enter First Human Trial
By David Cyranoski,
Nature
| 02. 14. 2013
It will be the first clinical study to put induced pluripotent stem (iPS) cells into humans — and where more fitting than in Japan, where Shinya Yamanaka garnered a Nobel prize last December for showing how to take bodily cells and return them to an embryo-like pluripotent state.
Masayo Takahashi of the
Center for Developmental Biology in Kobe just cleared the second and, observers say, most difficult hurdle in starting her iPS cell trial to treat age-related macular degeneration, a condition that affects the retina and can lead to blindness.
On Wednesday an institutional review board (IRB) at the
Institute for Biomedical Research and Innovation (IBRI), which is going to sponsor the trial, gave conditional approval. The team needs now only to notify the IRB of the final results of some preclinical safety trials now underway (
see story in Japanese).
Having already received IRB approval at her home institution, Takahashi can now move towards the final step before patient recruitment: getting health ministry approval. She’s expected receive that in time for starting the trials during this fiscal year...
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