The first death case in stem cell medical treatment has emerged.

If the past decade belonged to "ingredient-based skincare," then in the next decade, the competitive high ground in the beauty industry will undoubtedly shift towards "life sciences."

Among them, regenerative medicine, as a cutting-edge innovation direction in recent years, has attracted many beauty-related enterprises to enter the field. And stem cells, as one of the core technologies in this field, their market popularity and development prospects are self-evident.

However, beneath the spotlight, controversies and concerns are gradually emerging. Recently, Japan's Ministry of Health, Labour and Welfare issued an emergency ban stating that a 50-year-old foreign woman suffered a severe adverse reaction after receiving autologous adipose-derived mesenchymal stem cell (MSC) intravenous infusion therapy at the "TS Clinic" (now renamed "Tokyo Science Clinic") in a Tokyo medical institution, and died despite rescue efforts.

According to the information released by Japan's Ministry of Health, Labour and Welfare, this is the first case of patient death during regenerative medical treatment in free medical treatment (self-paid medical care) since Japan implemented the "Act on the Safety of Regenerative Medicine" in 2014.

Source: Official website of Japan's Ministry of Health, Labour and Welfare

As soon as the incident occurred, it quickly triggered extensive attention and discussions on the safety of stem cell applications. It is worth noting that after the incident, the involved clinic has changed its legal person name and medical institution name. Currently, the clinic is a regular medical institution under the Japan Medical Association.

First emergency ban issued due to patient death!

According to the content of the emergency ban issued by Japan's Ministry of Health, the patient was treated for chronic pain through regenerative medical means.

According to the reported content, the company responsible for cell processing this time is KOHJIN BIO located in Saitama Prefecture. The company was established in 1981, and its core business is cell processing for regenerative medicine, providing contract processing services such as isolation, culture, freezing, preservation, and quality inspection of autologous or allogeneic stem cells for medical institutions. It was listed on the Tokyo Stock Exchange Growth Market in April 2024.

The Ministry of Health, Labour and Welfare believes that the investigation into the cause of the patient's death is not sufficient, and " considering the process, the association with regenerative medicine cannot be ruled out." Therefore, it will continue to conduct an in-depth investigation into the cause of the patient's death. Currently, the Ministry of Health, Labour and Welfare has ordered the involved clinic to suspend regenerative medical treatment; KOHJIN BIO has also been required to suspend relevant cell preparation operations.

Source: Official announcement of KOHJIN BIO

Based on the speculations about the cause of death from the blogs of the director of Japan's Hirotsu Internal Medicine Clinic, Beijing Xinqiang Zhongke International Cells, and Cell Ocean, there are roughly the following three reasons:

1. Allergic reaction to cryoprotectant: Cryoprotectants such as DMSO contained in the infused cells, if not properly handled during the thawing and dilution process, may induce acute allergic reactions in some people, leading to respiratory and circulatory system failure;

2. Non-standard operation: Frozen cells tend to clump after thawing. If the infusion speed is too fast during the operation, it will increase the risk of vascular blockage;

3. Severe overdose: To attract more foreign customers, some clinics infuse 1 billion - 2 billion stem cells at one time. Excessive cells may clump together in the blood vessels, block microvessels, and cause acute circulatory disorders, which is extremely risky.

Then, why did this incident occur in Japan?

Looking back at history, it can be found that it has a certain relationship with the development of regenerative medicine in Japan. In fact, Japan began researching regenerative medicine in the 1980s and 1990s.

In 2012, Professor Shinya Yamanaka won the Nobel Prize in Physiology or Medicine that year for his research on "somatic cell reprogramming technology." This also made then-Prime Minister Shinzo Abe of Japan have high expectations for induced pluripotent stem cell research and promised to invest 110 billion yen (approximately 5.323 billion yuan) in the next decade to support the development of regenerative medicine.

In 2014, Japan began implementing the "Act on the Safety of Regenerative Medicine" and the "Pharmaceuticals and Medical Devices Act."

According to the provisions of the "Act on the Safety of Regenerative Medicine," regenerative medical treatments are classified into three categories according to different treatment risks, namely Class I regenerative medicine (including induced pluripotent stem cells, embryonic stem cells, and allogeneic stem cells), Class II regenerative medicine (including autologous stem cells, such as autologous adipose-derived stem cells), Class III regenerative medicine (such as dendritic cells, NK cells, and T cells).

Source: Xikang Wanjia

However, Li Ming, the CEO of the AESOMED brand focusing on exosome anti-aging, said in his personal video account that there are many "very strange" regulations in the "Act on the Safety of Regenerative Medicine" for biopharmaceutical people. For example, it allows Class II and III therapies to skip the Phase III clinical trial, and only needs to prove the preparation ability.

The WeChat public account CELL Class Representative analyzed this: "Japan prioritizes 'clinical demand efficiency' and uses the policy flexibility to develop individualized therapies. (Therefore), it classifies autologous adipose-derived stem cells as Class II (medium risk) and allogeneic stem cells as Class III (high risk). Medical institutions can start treatment after completing the filing, without the traditional drug approval process."

"(Japan's) requirements for safety are far less strict than we imagined. This regulatory model puts commercial promotion before scientific verification. So you can see that Japan's cell anti-aging industry is very prosperous, with various stem cell clinics blooming everywhere, but the actual technical level and safety are worrying." Li Ming said so in his video account.

In summary, Japan has a legal and refined risk classification, and low-risk autologous cell therapies can be clinically applied and charged after filing; moreover, the access speed of cell therapy products in Japan is relatively faster, and it pays more attention to rapid transformation and practical application.

But even so, "compliance" does not mean "high quality": even if a Japanese institution is legal and compliant, it does not completely mean that the quality, operation specification, or efficacy of the cell preparations it uses has reached the highest standard.

Different from Japan's "lenient" stem cell regulatory system, China's regulation is more cautious. In addition to being more prudent in the dual-track exploration of "drugs" and "medical technologies," currently allogeneic stem cell products need to undergo strict pre-market approval as drugs. The overall approval threshold is higher, and more emphasis is placed on full safety and efficacy verification before market entry.

According to the 21st Century Business Herald, Hainan passed the "Regulations on Promoting New Biomedical Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port" at the end of 2024, which once again strongly supports the transformation and application of new biomedical technologies such as stem cells from the policy and legal level. The "Regulations" consist of 28 articles, covering key links such as clinical trials, transformation and application, and price application, and came into effect on February 1, 2025.

Source: Hainan Provincial People's Government

The "Regulations" clearly state that in the pilot zone, it focuses on supporting the clinical research and transformation and application of new biomedical technologies such as cell therapy, gene therapy, and tissue engineering. However, the "Regulations" do not formulate specific indications, nor do they clearly mention the application of stem cells in anti-aging research.

The founder of a beauty brand told Jumeili that the stem cell treatment carried out in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan does have its particularity in terms of management category and project nature. It is not completely equivalent to the strict "clinical research" filing in the Chinese mainland, nor is it a completely marketed "drug." Instead, it is in an exploratory stage that combines "clinical research" and "transformation and application" with the help of the special policies of the Hainan Free Trade Port and the Lecheng Pilot Zone. It is neither a completely open market behavior nor a traditional and strict pure clinical research, but an intermediate path that takes into account the early accessibility of drugs for patients and data collection and verification.

Currently in Hainan, some approved institutions are also conducting application research on stem cells in skin repair, facial rejuvenation, etc. It should be particularly noted that the national regulatory authorities are very cautious in regulating such applications.

The current situation of China's exploration of regenerative medicine

It should be clear that although this incident exposes that the long-term and wide application safety of stem cell technology, as a cutting-edge scientific field, still needs to be fully verified, its scientific value and development prospects are still broad.

According to the prediction of Japan's Ministry of Economy, Trade and Industry, the scale of Japan's regenerative medical market will increase to 2.5 trillion yen (approximately 111.286 billion yuan) in 2050.

Source: Japan's Ministry of Economy, Trade and Industry

Focusing on the domestic market, according to the prediction of the Leopard Research Institute, the scale of China's regenerative medicine market is expected to increase to 92.66 billion yuan in 2030. The compound annual growth rate from 2026 - 2030 is 15%.

It is worth noting that in January this year, in the field of serious medical treatment, the first domestic stem cell therapy product - Amymeitosai Injection (trade name: Ruibosheng) was officially approved for marketing.

In addition, from the perspective of enterprises, regenerative medicine is also an important field where many domestic and foreign beauty leading enterprises are betting. Taking L'Oréal as an example, its four major research directions are: glycobiology, microbiome, exposome, and regenerative medicine.

In July this year, L'Oréal, together with many global dermatology and regenerative medicine experts, published a review in the international journal "Journal of Cosmetic Dermatology," systematically sorting out the six key directions affecting "skin longevity."

Domestically, Bloomage Biotechnology started to layout the research in the field of regenerative medicine in 2018 and elevated it to the corporate strategic level in 2020. In 2023, the Bloomage Biotechnology Regenerative Medicine R & D Center in Shanghai was officially opened. At the 2024 Jumeili Conference, Zhao Yan, the chairperson and president of Bloomage Biotechnology even shared with the public: Regenerative medicine is Bloomage Biotechnology's answer to precise cell regulation.

In addition, Gao Lang, the founder and chairperson of Gaolang Holdings also said in an interview with the video account @Qinwen and His Friends: "Regenerative medical skincare is a huge trend. In terms of the efficiency of solving problems, skincare is inefficient. We can see a big trend that medical aesthetics and skincare are merging, and I think regenerative medicine is a more efficient way. I know that its application scenarios are definitely not limited to consumer medical care. It has strong application scenarios in serious medical treatment. This is what I must do in - depth in the next decade."

However, in terms of stem cell cosmetics, Huang Dingchuan, the president of the Zhejiang Taiwanese Business Association and the chief representative of the American SAGE Medical Beauty Group has a different view. He said: "Putting stem cells in a cream and applying it on the face is a 'nonsense tax' even lower than a IQ tax. Stem cells may not even maintain their activity when stored at -80°C."

It should be noted that at the regulatory level, as early as September 2021, the National Medical Products Administration issued a document to popularize that "stem cell cosmetics" is a false concept. Currently, stem cell technology is still mostly in the clinical research stage in the medical field. There is no research on the application of stem cells in beauty and anti-aging in the stem cell clinical research filed with the health department.

Source: National Medical Products Administration

Therefore, Li Jincong, the founder of the Cosmetics Prohibited Words Network once said in an interview with Jumeili that medical terms such as 'cells' or 'stem cells' should not be associated with cosmetic claims (unless the National Medical Products Administration recognizes this fact). Using a large number of innovative terms or implying medical terms may make ordinary consumers unable to understand or misunderstand, thus being misled to consume, and merchants may also be involved in deceptive behavior.

Previously, Jumeili pointed out in its previous analysis reports that although beauty companies cannot replace biomedical institutions in conducting basic source research, life sciences have always been the key variable driving beauty innovation - whether it is L'Oréal's Pro-Xylane, Estée Lauder's peptide and DNA repair technology, or Bloomage Biotechnology's hyaluronic acid, all are manifestations of the transformation of life science achievements.

Therefore, for beauty enterprises, the more crucial thing is how to timely perceive the cutting - edge trends in life sciences, accurately identify the technical paths that can be transformed and applied in the beauty industry, and efficiently seize the market opportunities brought by them.

From the perspective of policy orientation, the state still holds a cautious and supportive attitude towards the stem cell