Commercialization of iPS Cells

The Ministry of Health, Labour and Welfare (MHLW) gave a greenlight for commercialization of induced pluripotent stem (iPS) cell which received Nobel Prize in Physiology or Medicine in 2012. It marked an important development in generative medicine in Japan, which the government of Japan promote as a country with advanced medical technology, even though it is a provisional license. 

Professor of Kyoto University, Shin-ya Yamanaka, was successful in producing a cell that had ability of differentiation into many cells and copying itself in 2006. It was expected to be used for medical treatment for serious disease of heart or Parkinson’s disease. Nobel committee approved the significance of Yamanaka’s achievement in identification of iPS cells as contribution to medical treatment of intractable diseases or development of new medicine for remedy.

 

A subcommittee of MHLW decided to approve two kinds of pharmaceuticals that used iPS cells, encouraging medical treatment for serious heart failure or Parkinson’s disease.

ReHeart was developed by a startup originated in University of Osaka, Cuorips, for treatment of ischemic cardiomyopathy. The drug can cultivate cells for reproducing blood vessels by attaching muscle patch on heart.

 

In the examinations of ReHeart, it was successful in easing symptoms from heart disease such as palpitation or tiredness. It is expected to replace current medical treatment on heart failure, which has been focused on maintenance of heart condition with dosing drugs or heart transplantation.

 

Amchepry generates nerve cells that produce dopamine. Dopamine is molecule for neuromodulation in brain, which administers moves of limbs. Shortage of dopamine causes Parkinson’s disease which brings shakes of armes and legs or stiffed body. Examinations of Amchepry, that planted iPS cells in patient’s head, showed obvious improvement in generating dopamine and physical function.

 

However, those medicines have not concluded sufficient cases of examination. The MHLW gave them a temporary license, because they still need evidences to prove effectiveness of their productions. Those pharmaceutical companies have to submit reports for official approval within seven years. Although the companies can sell those medical products for treatment of the diseases, they need to continue their research about the impact on human body.

 

Yamanaka insisted on importance of further research for reconfirmation of effectiveness and safety, as welcoming an important development of his iPS cells. There are some examples in which new medicine failed in commercialization after the temporary license was issued, lacking in collection of effective evidences.

 

Prime Minister Sanae Takaichi argues that she will do everything for economic growth. The government of Japan believes that not only investment in defense industry but that in science and technology will contribute to enhancing national interest in innovation. It is going to support development of iPS cells as a political agenda of current administration.

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