Jiji Press TOKYO (Jiji Press) — A health ministry panel conditionally approved Wednesday what is expected to be the world’s first clinical trial for transplants using induced pluripotent stem, or iPS, cells for heart disease treatment.
The regenerative medicine screening panel approved the trial planned by Osaka University depending on the meeting of conditions such as making explanatory documents for patients easier to understand.
The health minister will shortly give official approval to the plan to transplant sheets of heart muscle cells produced from donor iPS cells to severe heart disease patients.
Osaka University will conduct the first of the transplants by the end of March next year at the earliest to investigate the treatment’s safety and effectiveness.
The clinical trial plan was submitted to the health ministry in March by a research group led by Osaka University Prof. Yoshiki Sawa, who specializes in cardiovascular surgery.
At a news conference in Tokyo, Sawa said, “We’ll make a start in order to save as many patients’ lives as possible.”
The trial will cover three patients with heart failure resulting from ischemic cardiomyopathy, which is caused by clogged heart blood vessels.
The Osaka University team will use iPS cells made from the blood of healthy people and stockpiled at Kyoto University’s Center for iPS Cell Research and Application, headed by Shinya Yamanaka, the pioneer of iPS cells and the recipient of the 2012 Nobel Prize in Physiology or Medicine.
“I hope that the trial will lead to the establishment of a new treatment, after its safety and effectiveness are examined,” Yamanaka said in a statement. “I’d like to observe the developments carefully.”
The team plans to create heart muscle sheets from the iPS cells and transplant them into mice in order to check whether tumors will develop.
In the meantime, the team will select three patients aged between 18 and 79 who will receive transplants of heart muscle cell sheets.
It will observe the patients’ condition, checking whether cancer develops and whether the hearts’ functions improve, for example.
Proteins generated from the transplanted heart muscle cells are expected to grow into new blood vessels in the heart and help recovery of the heart’s functions, according to the team.
Since as many as about 100 million cells will be transplanted, researchers are concerned that iPS cells that fail to transform fully into heart muscle cells could develop into tumors.
In 2014, government-affiliated research institute Riken conducted the world’s first clinical trial for transplanting into eye disease patients retina cells created from iPS cells.