OSAKA - The world’s first clinical study for treating heart failure with so-called iPS cells could start in Japan in the coming months as the country’s health ministry approved a plan by Osaka University on Wednesday.
Under the plan, the university will place induced pluripotent stem cells into heart muscle cell sheets and transplant them into the hearts of the patients.
The plan was given the green light on the condition that the university thoroughly explains to the patients about the risks of using other people’s cells in the treatment.
“We’ve finally come to the starting point,” said Yoshiki Sawa, a cardiovascular surgery professor at the university.
“We hope to conduct the first transplant this fiscal year.”
Due to the risk involved, the clinical study needed to win approval from both a state-backed panel and the Ministry of Health, Labor and Welfare before it could be implemented.
IPS cells have been used in clinical studies for treating serious eye problems but have yet to be applied to heart failure, the second most common cause of death in Japan after cancer.
The university team led by Sawa plans to use a type of iPS cell kept at Kyoto University that it has deemed less likely to cause adverse reactions when transplanted. Three patients with severe ischemic cardiomyopathy — weakening of the heart muscle via heart attack or disease — will receive the treatment.
Proteins secreted from the transplanted cells are believed to promote cardiac muscle contraction and improve heart function.
Although the team has already tried transplanting cell sheets created from thigh muscles, cells of different muscles were found to be ineffective in treating serious heart failure.
Heart failure is a condition in which the heart muscle is unable to pump enough blood through the heart, causing shortness of breath and fatigue.
An estimated 1 million people in Japan suffer from the illness.