Clinical trials of bioengineering heart patch announced in Japan

Osaka University professor Yoshiki Sava describes his plans for treating heart failure in 2017

Pluripotent stem cells - iPSC - have unlimited potential in the world of regenerative medicine. One of the many possibilities of their use may be the recovery of sick hearts, which will soon be first tested in human clinical trials in Japan.

Since they were received at the Signa Yamanaki Laboratory in Japan in 2006, the potential of iPSC has been studied many times. We saw how they were implanted in rabbits to restore vision, used in the treatment of brain tumors and turned into cells of the predecessor of human organs.

Professor Yoshiki Sawa, a heart surgeon from Osaka University in Japan, is developing iPSC therapy for patients with heart disease. The technique includes the use of iPSC stored at the iPSC Center for Research and Application at Kyoto University , headed by Nobel Prize Winner Sinya Yamanaka, developing 0.1 mm thick patches of 100 million muscle cells and applying it to the heart, where they release growth factors that promote regeneration of the diseased muscle.

The technique was tested on pigs in 2017 and improved the function of the organ, so Sava quickly presented a research plan for conducting tests on humans. The plan has been approved by the Ministry of Health, Labor and Welfare of Japan. Trial treatment is assigned to three patients suffering from ischemic cardiomyopathy, a serious illness that occurs when narrowed coronary arteries limit the blood supply to the heart. Clinical trials have been scheduled for the end of March 2019, and it is planned to spend another 12 months to study the effects and potential safety problems.

This path to clinical application is possible thanks to the system of accelerated resolution , which was introduced in Japan in 2014. The system aims to expand the use of regenerative therapies using laws that allow the use of the latest treatment techniques, provided that they have shown their safety, and only with hints of their effectiveness.

The idea is that while patients receive safe treatment, more complete information can be gathered about its effectiveness. This excludes large-scale clinical trials that are conducted over several years and cost hundreds of millions.
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Heart failure is the second cause of death in the country. The group, led by Yoshiki Savoy, plans to begin a wider treatment of patients after five years.

Despite skepticism at some doctors , Yoshiki Sava's group will take part in the first clinical trial and will conduct an even more extensive trial involving 10 patients. If everything goes according to plan, treatment will soon appear on the market.