A health ministry panel has given conditional approval to two medical products derived from iPS cells, paving the way for the world’s first commercialization of Nobel Prize-winning stem cell research.
But Thursday’s endorsement of the products — neurons for Parkinson’s disease and muscle patches for severe heart disease — was based on small-scale clinical studies that confirmed only their safety and “presumed” their efficacy.
The manufacturers must conduct postmarket clinical trials to see if they actually work. If the efficacy is not fully proven, the ministry will withdraw approval within seven years.