Japan Approves the World’s First Treatment Made With Reprogrammed Human Cells

On March 6, Japan’s Ministry of Health, Labor and Welfare officially granted conditional and time-limited marketing authorization to two regenerative medical products derived from reprogrammed iPS cells, marking exactly 20 years since the creation of mouse iPS cells. These will be the world's first practical application of iPS cell-derived products.

“We are very pleased to have taken a major step toward social application on the 20th anniversary of the announcement of mouse iPS cells,” said Shinya Yamanaka, director emeritus of the iPS Cell Research Institute at Kyoto University. “To establish it as a medical treatment, it is essential to go through the process of confirming its safety and efficacy in many more cases. I believe it is important that we continue to move forward steadily, step by step, with scientific caution and without getting carried away.”

What Are iPS cells?

The initialism stands for induced pluripotent stem cells. These are adult cells, such as skin or blood cells, that have been reprogrammed to function like embryonic stem cells. They can divide indefinitely and can take the form of any cell type. Thanks to this ability, they can be used to test new drugs and for research in regenerative medicine. This type of cell allows for scientific advancement without the ethical problems that arise from working with embryonic stem cells.

Sheets of Cells Attached to the Wall of the Heart

One of the regenerative medicine products that has been approved is ReHeart, from Qualipse, a startup based at Osaka University. It's a sheet of specialized heart cells called cardiomyocytes differentiated from iPS cells of healthy donors, and it generated considerable buzz when it was presented at the Osaka-Kansai Expo. It's intended for patients with severe heart failure due to ischemic cardiomyopathy who don't recover sufficiently despite standard treatment, including drug therapy and invasive procedures.