A Japanese team of physicians won approval Friday from an Osaka University panel for its plan to carry out the world's first clinical study for treating heart failure with sheets of cardiac muscle cells created from so-called iPS cells.
Given the panel's approval for the regenerative medicine project, Osaka University professor Yoshiki Sawa and his colleagues applied with the health ministry later in the day to carry out the clinical study.
If approved, the study is expected to begin within months.
Under the project, a team led by Sawa, a professor of cardiovascular surgery at the university, plans to convert induced pluripotent stem (iPS) cells into a cardiac muscle cell sheet that is several centimeters in diameter and 0.1 millimeter thick, and transplant it into the hearts of three ischemic cardiomyopathy patients.
The doctors will monitor the method's safety and effectiveness in curing the heart disease.
The clinical study on the method is designated as "class 1" high-risk regenerative medicine that needs to win approval from both a state-backed panel set up at universities and medical institutions, and the Health, Labor and Welfare Ministry for implementation.
Sawa's team plans to use a type of iPS cell deemed less likely to cause adverse reactions, in cooperation with Nobel laureate Shinya Yamanaka of Kyoto University.
Sawa's team has already developed cardiac muscle cell sheets using muscles from patients' thighs, but transplantation into their hearts was found to be ineffective in curing those with serious conditions due to differences with the type of muscles in those body parts.
The doctors believe that by applying iPS cell-derived cardiac muscle cell sheets to the hearts of ischemic cardiomyopathy patients, transplanted cells could eventually become part of their hearts and improve the therapeutic effects of heart failure treatment.