[Team Leader’s Column] The Era of Second-Generation Stem Cell Therapies Begins

As part of a New Year feature, I recently published an article arguing that Korea and Japan should cooperate in the development of stem cell therapies. Since then, I have received responses from several quarters. Some agreed that the article was correct in pointing out the overwhelming lead of the United States in new stem cell drug development, while others noted that similar concerns and calls for reflection are emerging within Japan itself. There was also advice that Korea should begin preparing for the era of second-generation stem cells.

Scientists say that the age of true stem cell-based medicines—going beyond the “stem cell anti-aging injections” currently offered at some clinics in Japan—is approaching.

Stem cells are broadly divided into embryonic stem (ES) cells, induced pluripotent stem (iPS) cells, and adult stem cells. Embryonic stem cells are primitive cells obtained from sources such as fertilized eggs, while iPS cells are mature cells that have been genetically reprogrammed back into a primitive, stem cell-like state.

Adult stem cells can be obtained from tissues such as the placenta, bone marrow, and adipose tissue. They are naturally involved in replacing damaged cells in the body.

Embryonic stem cells and iPS cells, discovered by Japanese scientist Shinya Yamanaka, have much greater regenerative potential than adult stem cells. However, embryonic stem cells have raised ethical concerns, while iPS cells have required further validation of their safety when introduced into the human body. For this reason, research on adult stem cells began earlier.

In the scientific community, adult stem cells are often described as first-generation stem cells, while embryonic stem cells and iPS cells are considered second-generation stem cells.

Prof. Dong-Wook Kim of the Department of Physiology at Yonsei University College of Medicine explained that the U.S. Food and Drug Administration’s willingness to authorize clinical trials of stem cell therapies reflects the efforts of scientists over the past decade. Researchers have worked to resolve the medical safety issues associated with second-generation stem cells and have gradually accumulated scientific evidence demonstrating their viability.

Japan’s problem, according to some observers, is that after Yamanaka won the Nobel Prize in 2012, the country concentrated its support heavily on iPS cell research while giving less attention to other approaches.

The United States, by contrast, continued pursuing research on both embryonic stem cells and iPS cells. This difference, some argue, contributed to the divergence in outcomes between the two countries.

The Parkinson’s disease stem cell therapy recently advanced by Bayer with authorization from the U.S. FDA is based on embryonic stem cells. So far, there has been no comparable case in which an iPS cell-based therapy has received FDA authorization for a commercial-stage clinical program. In fact, when embryonic stem cell therapies are considered on their own, some experts believe Korea may be ahead of Japan.

There are also reports that Japanese scientists working on stem cell approaches other than iPS cells sometimes look to Korea with envy.

In Korea, embryonic stem cell research is also opening new possibilities for diseases once considered incurable, including Parkinson’s disease. Prof. Kim’s team is scheduled to conduct a clinical trial at Severance Hospital on the 5th, transplanting dopamine-producing stem cells derived from embryonic stem cells into the eighth patient with Parkinson’s disease.

However, iPS cells offer greater potential for broader expansion of research.

Stem cells are central not only to treating intractable diseases but also to anti-aging research. This is no longer simply about transplanting stem cells to make skin look smoother. We have entered an era in which cellular reprogramming itself has become possible.

For example, studies showing that aged mice with progeria-like conditions could be rejuvenated using iPS cell reprogramming technology are based on this concept of reversing cellular differentiation.

The scientist who led that line of research drew enormous attention at an Altos Labs lecture in Boston last July, where the venue was packed with attendees.

Although Japan’s standing has recently been challenged, its research on iPS cell therapies remains among the world’s best.

Korea, meanwhile, may lag Japan in regenerative medicine, but it has world-class biopharmaceutical manufacturing capabilities through companies such as Samsung Biologics and Celltrion. Korea’s dynamic and fast-moving biotechnology startup ecosystem is another major strength.

Experts believe that combining Korea’s manufacturing capacity and execution speed with Japan’s technological expertise could create a win-win partnership for both countries in regenerative medicine.

Japan also has a long history in the pharmaceutical and biotechnology industries, with deep experience in globalization and mergers and acquisitions. There is much that Korea’s traditional pharmaceutical companies can learn from that experience.

With relations between Korea and Japan improving under the current administration, this may be an important opportunity for Korea to join forces with Japan, a long-standing leader in stem cell research, and make a significant leap forward.

Korea should use its characteristic entrepreneurial spirit to pursue stronger collaboration with Japan. It must not miss the opportunity to rebuild the momentum in stem cell research that was severely disrupted after the research misconduct scandal involving former Seoul National University professor Hwang Woo-suk.