OSAKA - A new treatment using iPS cells, known for their ability to transform into any type of cell in the body, is poised to become the first of its kind in the world. A venture from Osaka University has applied to the Ministry of Health, Labor and Welfare for approval to manufacture and market the innovative therapy.
This therapy, which involves attaching a beating sheet of heart muscle cells derived from iPS cells to damaged hearts, could become the world’s first approved treatment of its kind. The company behind the development, Cuorips, announced on April 8th that it had submitted an application to Japan’s Ministry of Health, Labor and Welfare for approval to manufacture and sell the heart cell sheet. Clinical trials on eight patients have yielded promising results, giving hope to those suffering from severe heart conditions such as ischemic cardiomyopathy.
The innovation is on display just ahead of the Osaka-Kansai Expo, where one of the highlights is a small but remarkable model heart, measuring about five centimeters across. It visibly beats at a rate of approximately 50 times per minute. This tissue is made from around 200 million iPS-derived cardiomyocytes, which can transform into any cell type. The technology was led by Yoshiaki Sawa, specially appointed professor at Osaka University, who has spent years refining the technique of creating the heart muscle cell sheet.
Sawa explains that the sheet is placed directly onto the heart through a small surgical incision, without the need to cut into the heart itself. It attaches naturally within 10 to 15 minutes, and within about six hours, new blood vessels begin growing from the heart into the sheet. Initially, the sheet does not have its own blood flow, but once connected, it begins to release substances like cytokines that help repair the heart. Over time, the cells in the sheet gradually diminish, but not before stimulating the regeneration of blood vessels and supporting weakened cardiac tissue.
One patient who underwent the clinical trial, a man in his 50s, reported significant improvements in his quality of life. He said that before the treatment, even completing a full round of golf was impossible, but afterward, he was able to play 18 holes without difficulty. Such feedback underlines the real-world impact the treatment could have if it reaches full approval and widespread use.
In a studio interview, Sawa elaborated on how the technology mimics the function of a real heart outside the body. He explained that the cardiomyocytes beat independently but synchronize with each other, guided by the cell with the strongest electrical signal. This orchestrated motion is essential for effective blood pumping and is now being replicated in the lab.
The simplicity and low invasiveness of the procedure stand out. The surgery takes roughly one hour and involves placing three sheets on the heart. Because the heart is already in a weakened state in cases of heart failure, the goal is to provide support without causing further stress. The approach allows for healing without traditional cutting or stitching of heart tissue.
As time passes, not only do blood vessels grow, but overall heart function continues to improve. Sawa observed that patients experience progressive recovery, with many able to return to work and regain social functionality. Over the course of five years, eight patients have received the treatment, and most have successfully reintegrated into daily life.
The new treatment comes as an alternative to conventional options such as medication, artificial hearts, or transplants. By using the body's regenerative capabilities through iPS cells, the heart cell sheet represents a less invasive yet potentially powerful method to combat chronic heart failure. With regulatory approval pending, the therapy could mark a significant milestone in regenerative medicine and offer hope to patients worldwide.
Source: TBS
