Editorial: Japan must quickly commercialize iPS-based treatment by overcoming challenges
Research into treatment using induced pluripotent stem (iPS) cells has been generating positive results one after another. Amid high expectations among patients struggling with intractable illnesses and their families, it is hoped that progress converting the technology to practical use will be quick.
A clinical trial conducted by a team of Kyoto University researchers targeting Parkinson's disease patients has found that the conditions of some of the subjects administered with nerve cells generated from iPS cells have improved. Another trial on Type 1 diabetes patients triggered the cells to secrete insulin, responsible for lowering blood sugar levels.
In a world first, Keio University led a clinical study using iPS cells on patients with spinal cord injuries and saw some of the subjects' motor functions improve. In April, a startup launched at the University of Osaka applied for approval from the health ministry to manufacture and distribute heart muscle sheets prepared from iPS cells for treating heart disease, marking the first application of its kind for regenerative medicine products derived from iPS cells.
These are epoch-making results for diseases that were previously difficult to treat. There arose no safety issues during the research phase, implying that these achievements have brought us a step closer to getting the technology into practical use.
With their ability to develop into a variety of tissues, iPS cells have been under the spotlight for their potential to recover functions lost to illnesses. Kyoto University professor Shinya Yamanaka, who developed iPS cells, was awarded the Nobel Prize in physiology or medicine.
There remain, however, challenges that must be overcome.
Increasing the number of iPS-derived cells administered to patients to boost efficacy raises carcinogenic risks. Unlike medicinal compounds, quality may vary among living cells used in the treatment. Careful checks are indispensable.
Further confirmation of the efficacy of the iPS-based treatment is also essential. So far, clinical trials and studies have turned up different effects among individual patients.
Due to the high development cost, patients undergoing the treatment are expected to face hefty bills. As there are fewer patient samples compared to those given general new drugs, it won't be easy to collect data.
Companies seeking to commercialize the regenerative medicine products are likely to use a system allowing them to hit the market for a set period on condition that the firms acquire additional data on their efficacy, among other requirements. The system is unique to Japan, enabling applications for marketing drugs once their efficacy can be estimated.
Even though approval for such products is considered a mere "provisional permit," it can lead to treatment in the very near term.
It is hoped that Japan will continue to steadily resolve challenges and make its world-leading technology flourish as a medical revolution.
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