iPS: Launch of the First International Clinical Trial in Humans

Publié le : 26 July 2013

 On Friday 19 July, the Japanese authorities gave permission for the launch of the first regenerative medicine international clinical trials in humans for the treatment of age-related macular degeneration (AMD) using induced pluripotent stem cells (iPS). This authorisation was granted to Professor Masayo Takahashi in conjunction with the Japanese Research and Biomedical Innovation Institute as well as Kobe Medical City Hospital General Centre (hiPSCs), and will focus on a cohort of 6 AMD patients. The latter will be followed-up for 1 to 3 years.
In actual fact, researchers will collect "skin cells from the patients’ arms, […] reprogramme them into iPS stem cells, [and] […] change them into retina cells for subsequent reimplantation in the patients’ eyes. The entire procedure should take approximately 8 months". iPS cells will therefore be created "from adult cells reduced to the virtually embryonic state by making them re-express 4 genes (generally inactive in adult cells)".      
The aim of these human trials is to "demonstrate the safety and efficacy of the technique in treating one of the wettest and delayed forms of AMD, namely the neovascular form”. This is the most common form of AMD, accounting for almost 90% of cases. It is the main cause of blindness in the over 55 year-olds. 

Research into iPS cells has become a priority in Japan. In fact, the State "decided to make considerable financial investments in what it considers to be an extremely promising sector in which the Japanese should get a head start". 

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