Japan is set to host the world’s first clinical trials involving the use of induced pluripotent stem (iPS) cells to treat heart failure.
A special health ministry panel on Wednesday gave Osaka University the green light to carry out the study, pending final authorization from the health minister. This would be the second instance of using iPS-derived cells for disease treatment in Japan, after groundbreaking trials involving retinal cells launched in 2014.
The research team, led by Osaka University professor Yoshiki Sawa, aims to start treating patients on a wider basis in five years. Before that, the trial treatment will be administered to three patients suffering from ischemic cardiomyopathy, a serious condition that occurs when narrowed coronary arteries limit the supply of blood to the heart. The plan is to start the trials by the end of next March and spend a year examining the effects and potential safety issues.
The researchers will grow cardio muscle cells created from iPS cells stocked at the Center for iPS Cell Research and Application at Kyoto University, where Nobel laureate Shinya Yamanaka serves as director. The created cells, in the form of 0.1 millimeter-thick sheets, will be layered onto the surface of the patient’s heart. As the sheets secrete protein, the nutrition is expected to help grow blood vessels and improve heart functions.
Heart failure causes symptoms such as shortness of breath and fatigue. In serious cases, patients require an auxiliary artificial heart, or a heart transplant from a donor. Neither option is ideal: Artificial hearts come with the risk of complications, and there are not enough donors. The iPS-based treatment could offer a way around those limitations.
Sawa’s team submitted its plan to the Japanese Ministry of Health, Labor and Welfare in March. The panel, including regenerative medicine experts, approved it on the condition that trial patients should be chosen with the same criteria used for regenerative treatments already on the market.