First human induced pluripotent stem cell trial approved in Japan

japan ips age-related macular degeneration stem cells (Σ64 http://commons.wikimedia.org/wiki/File:Mt.Fuji_from_Kitadake-sansou_01.jpg)

Last year, two scientists won a Nobel Prize for their discovery of induced pluripotent stem (iPS) cells. One of those was Japanese professor Shinya Yamanaka. It would seem fitting, therefore, that the next breakthrough with iPS cells might also emerge from Japan – and from no place other than Kobe, where Yamanaka obtained his MD.

We've been wondering for some time whether Japan would approve plans put forward by Masayo Takahashi and her team at RIKEN Center for Developmental Biology for the first-ever test of induced pluripotent stem (iPS) cells in humans. The clinical study would test the use of iPS cells in treating age-related macular degeneration (AMD), but some critics expressed concern that such a study would move the medical application of iPS cells along too fast. There were concerns about tumour formation or the triggering of immune reactions, but the pre-clinical data looked promising and results from a human trial with iPS cells would push the regenerative medicine field into truly ground-breaking territory.

Japan's decision is great news for the study. The health minister, Norihisa Tamura, has ruled that the clinical study iPS cells can be transplanted into the 6 AMD patients – an announcement that Professor Chris Mason, University College London, described as "expected", but "obviously a major step forward."

He told the BBC: “They [iPS cells] are beneficial for two main reasons. One, they are from the patients themselves so the chance of rejection is greatly reduced and there are the ethical considerations – they do not have the baggage which comes with embryonic stem cells."

However, he was also cautious about safety concerns associated with the trial. “On the down side we are a decade behind on the science. Induced pluripotent stem cells were discovered much later, so we’re behind on the safety.”

An article earlier this year in Nature points out that the trial is a ‘clinical study' – which is slightly less regulated than a clinical trial and cannot by itself lead to approval for clinical use. Positive data from the trial, however, might help attract investors or add weight to an application for a formal clinical trial in the future.

Read more at the BBC >

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