Japan's Ministry of Health, Labour and Welfare (MHLW) has become the first in the world to grant approval to the world's first innovative stem cell therapy for severe heart failure. The permission is conditional and based on a specific time duration for targeted regenerative medicine products for both severe heart failure and Parkinson's disease. Regenerative medicinal products focus on re-engineering parts of human or animal cells to restore the normal function of body tissues. The world's first pluripotent stem cell (iPSC)-based medicinal product, named ReHeart, has been developed by a company specializing in the creation of innovative medicinal products. This milestone is a major win for the global and Indian markets, as it is the first time that iPSC technology has been turned into commercial therapeutic products that were discovered in 2006.

Globally, heart disease affects 233 million people, out of which 19.41 million deaths were recorded, as per a recent joint report by the American Heart Association and Stroke Statistics Update. While in India, the number of cardiovascular diseases is 905 per 100,000 population (2021), and the deaths were at 2,873,266 as per the World Heart Federation. Not only are these figures alarming, but the need for global regenerative medicine could significantly minimise this global disease burden.

What Are iPSCs?

The stem cells could offer a chance of reversing the damage caused by severe heart failure. Severe heart failure is an end-stage heart condition wherein the heart is unable to pump the blood required throughout the body to meet its needs, leading to life-threatening symptoms and complications. The engineered stem cells that utilise iPSC technology and stem cell reprogramming are created from adult cells and can be transformed to adapt into any type of cell in the human body.

Source: NDTV - March 17,2026