Patch against cardiomyopathy
Clinical trials of bioengineered patch on heart announced in Japan
Ariel Finerman, Habr
Osaka University Professor Yoshiki Sava describes his plans for the treatment of heart failure in 2017
Pluripotent stem cells – iPSC – have limitless potential in the world of regenerative medicine. One of the many possibilities of their application may be the restoration of diseased hearts, which will soon be tested for the first time in human clinical trials in Japan. Since they were obtained at the Shinya Yamanaki Laboratory in Japan in 2006, the potential of iPSC has been studied many times. We have seen how they were implanted in rabbits to restore vision, used in the treatment of brain tumors and turned into precursor cells of human organs.
Professor Yoshiki Sava, a cardiac surgeon at Osaka University in Japan, is developing iPSC therapy for patients with heart disease. The technique involves using iPSCs stored at the iPSC Research and Application Center at Kyoto University, headed by Nobel laureate Shinya Yamanaka, developing a 0.1 mm thick patch of 100 million muscle cells from them 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 organ function, so Sava quickly submitted a research plan for human trials. The plan has received permission from the Ministry of Health, Labor and Welfare of Japan. Trial treatment was prescribed to three patients suffering from ischemic cardiomyopathy, a serious disease that occurs when narrowed coronary arteries restrict blood supply to the heart. Clinical trials are scheduled for the end of March 2019, and it is planned to spend another 12 months studying the effectiveness and potential safety problems. This path to clinical application is possible thanks to the accelerated resolution system, which was introduced in Japan in 2014. The system is aimed at expanding the use of regenerative therapy methods with the help of 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 as long as patients receive safe treatment, more complete information about its effectiveness can be collected. This excludes large-scale clinical trials that have been conducted for several years and cost hundreds of millions.
Heart failure is the second cause of death in the country. The group, led by Yoshiki Sava, plans to begin broader treatment of patients in five years.
Despite skepticism from some doctors, Yoshiki Saw's group will take part in the first clinical trial and conduct an even larger trial involving 10 patients. If everything goes according to plan, the treatment will soon be on the market.
Portal "Eternal youth" http://vechnayamolodost.ru